Ignite Creation Date:
2025-12-24 @ 10:10 PM
Ignite Modification Date:
2025-12-25 @ 7:46 PM
Study NCT ID:
NCT01032135
Status:
COMPLETED
Last Update Posted:
2017-09-05
First Post:
2009-12-14
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Adaptive Treatment for Alcohol and Cocaine Dependence
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}], 'ancestors': [{'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D062405', 'term': 'Motivational Interviewing'}, {'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}, {'id': 'D003376', 'term': 'Counseling'}, {'id': 'D054539', 'term': 'Medication Therapy Management'}], 'ancestors': [{'id': 'D037001', 'term': 'Directive Counseling'}, {'id': 'D008605', 'term': 'Mental Health Services'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D003153', 'term': 'Community Health Services'}, {'id': 'D010593', 'term': 'Pharmaceutical Services'}, {'id': 'D054524', 'term': 'Medicare Part D'}, {'id': 'D007356', 'term': 'Insurance, Pharmaceutical Services'}, {'id': 'D007348', 'term': 'Insurance, Health'}, {'id': 'D007341', 'term': 'Insurance'}, {'id': 'D005381', 'term': 'Financing, Organized'}, {'id': 'D004467', 'term': 'Economics'}, {'id': 'D004472', 'term': 'Health Care Economics and Organizations'}, {'id': 'D006278', 'term': 'Medicare'}, {'id': 'D010346', 'term': 'Patient Care Management'}, {'id': 'D006298', 'term': 'Health Services Administration'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jimrache@mail.med.upenn.edu', 'phone': '215-746-7704', 'title': 'James McKay, PhD', 'organization': 'University of Pennsylvania'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '24 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Engaged', 'description': 'Engaged at week 2 and remained engaged throughout the 8 weeks of study participation. This group did not receive any treatment intervention.', 'otherNumAtRisk': 227, 'deathsNumAtRisk': 227, 'otherNumAffected': 0, 'seriousNumAtRisk': 227, 'deathsNumAffected': 0, 'seriousNumAffected': 34}, {'id': 'EG001', 'title': 'MI-PC Non-engaged at 2 Weeks', 'description': 'Participants start at IOP, but at 2 weeks are non-engaged.\n\nRandomized to treatment choice:\n\nMotivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.\n\nTelephone counseling: one telephone counseling session per week for 10 weeks.\n\nCognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.\n\nMedication Management: Prescription for naltrexone\n\nIntensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day.', 'otherNumAtRisk': 93, 'deathsNumAtRisk': 93, 'otherNumAffected': 0, 'seriousNumAtRisk': 93, 'deathsNumAffected': 0, 'seriousNumAffected': 16}, {'id': 'EG002', 'title': 'MI-IOP Non-Engaged at 2 Weeks', 'description': 'Participants start at IOP, but at 2 weeks are non-engaged.\n\nRandomized to IOP\n\nMotivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.', 'otherNumAtRisk': 96, 'deathsNumAtRisk': 96, 'otherNumAffected': 0, 'seriousNumAtRisk': 96, 'deathsNumAffected': 0, 'seriousNumAffected': 9}, {'id': 'EG003', 'title': 'MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks', 'description': 'Participants start at IOP, Engaged at 2 weeks but disengage between 3 - 8 weeks.\n\nRandomized to treatment choice:\n\nMotivational Interviewing: 2 sessions at week 2\n\nTelephone counseling: one telephone counseling session per week for 10 weeks.\n\nCognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.\n\nMedication Management: Prescription for naltrexone\n\nIntensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day.', 'otherNumAtRisk': 41, 'deathsNumAtRisk': 41, 'otherNumAffected': 0, 'seriousNumAtRisk': 41, 'deathsNumAffected': 1, 'seriousNumAffected': 4}, {'id': 'EG004', 'title': 'MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks', 'description': 'Initially engaged at IOP, but become non-engaged in weeks 3 - 8.\n\nRandomized to IOP\n\nMotivational Interviewing: 2 sessions at week 2', 'otherNumAtRisk': 43, 'deathsNumAtRisk': 43, 'otherNumAffected': 0, 'seriousNumAtRisk': 43, 'deathsNumAffected': 0, 'seriousNumAffected': 4}], 'seriousEvents': [{'term': 'Hospitalizations', 'notes': 'The SAEs reported ranged from suicide attempts and depression, to detox and overdose, to migraines. The SAEs were found from searches of electronic medical records and were not study related. The participants were not receiving interventions.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 96, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 41, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 43, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Treatment Engagement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}, {'value': '96', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Engaged', 'description': 'Engaged at week 2 and remained engaged throughout the 8 weeks of study participation.\n\nThis group did not receive any treatment intervention.'}, {'id': 'OG001', 'title': 'MI-PC Non-engaged at 2 Weeks', 'description': 'Participants start at IOP, but at 2 weeks are not engaged. Randomized to treatment choice:\n\nMotivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.\n\nTelephone counseling: one telephone counseling session per week for 10 weeks.\n\nCognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.\n\nMedication management: Prescription for naltrexone\n\nIntensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day.'}, {'id': 'OG002', 'title': 'MI-IOP Non-Engaged at 2 Weeks', 'description': 'Participants begin at IOP, but at 2 weeks are determined to no longer be engaged.\n\nRandomized to IOP\n\nMotivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.'}, {'id': 'OG003', 'title': 'MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks', 'description': 'Randomized to treatment choice, but remain attending treatment as usual then dropped out of treatment after randomization.\n\nMotivational Interviewing: 2 sessions at time of disengagement presenting treatment choices to participants.\n\nTelephone counseling: one telephone counseling session per week for 10 weeks.\n\nCognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.\n\nMedication Management: Prescription for Naltrexone'}, {'id': 'OG004', 'title': 'MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks', 'description': 'Initially engaged at IOP, but become nonengaged in weeks 3 - 8.\n\nMotivational Interviewing: 2 sessions at time of disengagement.\n\nReturn to IOP therapy 3 times weekly for three hours a day'}, {'id': 'OG005', 'title': 'MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks', 'description': 'Began study in IOP but was nonengaged at week 2. Randomized to Patient Choice.\n\nMotivational Interviewing: 2 sessions at week 2 presenting treatment choices to participants.\n\nTelephone counseling: one telephone counseling session per week for 10 weeks.\n\nCognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.\n\nMedication Management: Prescription for Naltrexone'}, {'id': 'OG006', 'title': 'No Further Intervention', 'description': 'Not engaged at week 2 and still not engaged at week 8.\n\nRandomized to receive no further study intervention.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.92', 'spread': '3.27', 'groupId': 'OG001'}, {'value': '3.50', 'spread': '3.23', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.11', 'groupIds': ['OG001', 'OG002'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'weeks 3 - 12', 'description': 'Number of treatment sessions attended', 'unitOfMeasure': 'treatment days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Treatment Engagement for Participants Engaged at 2 Weeks, But Disengage Before 8 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}, {'value': '38', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Engaged', 'description': 'Engaged at week 2 and remained engaged throughout the 8 weeks of study participation.\n\nThis group did not receive any treatment intervention.'}, {'id': 'OG001', 'title': 'MI-PC Non-engaged at 2 Weeks', 'description': 'Participants start at IOP, but at 2 weeks are not engaged. Randomized to treatment choice:\n\nMotivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.\n\nTelephone counseling: one telephone counseling session per week for 10 weeks.\n\nCognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.\n\nMedication management: Prescription for naltrexone\n\nIntensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day.'}, {'id': 'OG002', 'title': 'MI-IOP Non-Engaged at 2 Weeks', 'description': 'Participants begin at IOP, but at 2 weeks are determined to no longer be engaged.\n\nRandomized to IOP\n\nMotivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.'}, {'id': 'OG003', 'title': 'MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks', 'description': 'Randomized to treatment choice, but remain attending treatment as usual then dropped out of treatment after randomization.\n\nMotivational Interviewing: 2 sessions at time of disengagement presenting treatment choices to participants.\n\nTelephone counseling: one telephone counseling session per week for 10 weeks.\n\nCognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.\n\nMedication Management: Prescription for Naltrexone'}, {'id': 'OG004', 'title': 'MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks', 'description': 'Initially engaged at IOP, but become nonengaged in weeks 3 - 8.\n\nMotivational Interviewing: 2 sessions at time of disengagement.\n\nReturn to IOP therapy 3 times weekly for three hours a day'}, {'id': 'OG005', 'title': 'MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks', 'description': 'Began study in IOP but was nonengaged at week 2. Randomized to Patient Choice.\n\nMotivational Interviewing: 2 sessions at week 2 presenting treatment choices to participants.\n\nTelephone counseling: one telephone counseling session per week for 10 weeks.\n\nCognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.\n\nMedication Management: Prescription for Naltrexone'}, {'id': 'OG006', 'title': 'No Further Intervention', 'description': 'Not engaged at week 2 and still not engaged at week 8.\n\nRandomized to receive no further study intervention.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.28', 'spread': '1.55', 'groupId': 'OG003'}, {'value': '0.76', 'spread': '1.25', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.02', 'groupIds': ['OG003', 'OG004'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'weeks 9 - 12', 'description': 'Number of treatment sessions attended', 'unitOfMeasure': 'treatment days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Treatment Engagement of Those Non-engaged at 2 Weeks and at 8 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '36', 'groupId': 'OG005'}, {'value': '41', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Engaged', 'description': 'Engaged at week 2 and remained engaged throughout the 8 weeks of study participation.\n\nThis group did not receive any treatment intervention.'}, {'id': 'OG001', 'title': 'MI-PC Non-engaged at 2 Weeks', 'description': 'Participants start at IOP, but at 2 weeks are not engaged. Randomized to treatment choice:\n\nMotivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.\n\nTelephone counseling: one telephone counseling session per week for 10 weeks.\n\nCognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.\n\nMedication management: Prescription for naltrexone\n\nIntensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day.'}, {'id': 'OG002', 'title': 'MI-IOP Non-Engaged at 2 Weeks', 'description': 'Participants begin at IOP, but at 2 weeks are determined to no longer be engaged.\n\nRandomized to IOP\n\nMotivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.'}, {'id': 'OG003', 'title': 'MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks', 'description': 'Randomized to treatment choice, but remain attending treatment as usual then dropped out of treatment after randomization.\n\nMotivational Interviewing: 2 sessions at time of disengagement presenting treatment choices to participants.\n\nTelephone counseling: one telephone counseling session per week for 10 weeks.\n\nCognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.\n\nMedication Management: Prescription for Naltrexone'}, {'id': 'OG004', 'title': 'MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks', 'description': 'Initially engaged at IOP, but become nonengaged in weeks 3 - 8.\n\nMotivational Interviewing: 2 sessions at time of disengagement.\n\nReturn to IOP therapy 3 times weekly for three hours a day'}, {'id': 'OG005', 'title': 'MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks', 'description': 'Began study in IOP but was nonengaged at week 2. Randomized to Patient Choice.\n\nMotivational Interviewing: 2 sessions at week 2 presenting treatment choices to participants.\n\nTelephone counseling: one telephone counseling session per week for 10 weeks.\n\nCognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.\n\nMedication Management: Prescription for Naltrexone'}, {'id': 'OG006', 'title': 'No Further Intervention', 'description': 'Not engaged at week 2 and still not engaged at week 8.\n\nRandomized to receive no further study intervention.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.58', 'spread': '1.11', 'groupId': 'OG005'}, {'value': '0.30', 'spread': '0.76', 'groupId': 'OG006'}]}]}], 'analyses': [{'pValue': '0.005', 'groupIds': ['OG005', 'OG006'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'weeks 9 - 12', 'description': 'Number of treatment sessions attended', 'unitOfMeasure': 'treatment days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Any Drinking Days in Previous Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}, {'value': '63', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}, {'value': '37', 'groupId': 'OG004'}, {'value': '30', 'groupId': 'OG005'}, {'value': '32', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Engaged', 'description': 'Engaged at week 2 and remained engaged throughout the 8 weeks of study participation.\n\nThis group did not receive any treatment intervention.'}, {'id': 'OG001', 'title': 'MI-PC Non-engaged at 2 Weeks', 'description': 'Participants start at IOP, but at 2 weeks are not engaged. Randomized to treatment choice:\n\nMotivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.\n\nTelephone counseling: one telephone counseling session per week for 10 weeks.\n\nCognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.\n\nMedication management: Prescription for naltrexone\n\nIntensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day.'}, {'id': 'OG002', 'title': 'MI-IOP Non-Engaged at 2 Weeks', 'description': 'Participants begin at IOP, but at 2 weeks are determined to no longer be engaged.\n\nRandomized to IOP\n\nMotivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.'}, {'id': 'OG003', 'title': 'MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks', 'description': 'Randomized to treatment choice, but remain attending treatment as usual then dropped out of treatment after randomization.\n\nMotivational Interviewing: 2 sessions at time of disengagement presenting treatment choices to participants.\n\nTelephone counseling: one telephone counseling session per week for 10 weeks.\n\nCognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.\n\nMedication Management: Prescription for Naltrexone'}, {'id': 'OG004', 'title': 'MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks', 'description': 'Initially engaged at IOP, but become nonengaged in weeks 3 - 8.\n\nMotivational Interviewing: 2 sessions at time of disengagement.\n\nReturn to IOP therapy 3 times weekly for three hours a day'}, {'id': 'OG005', 'title': 'MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks', 'description': 'Began study in IOP but was nonengaged at week 2. Randomized to Patient Choice.\n\nMotivational Interviewing: 2 sessions at week 2 presenting treatment choices to participants.\n\nTelephone counseling: one telephone counseling session per week for 10 weeks.\n\nCognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.\n\nMedication Management: Prescription for Naltrexone'}, {'id': 'OG006', 'title': 'No Further Intervention', 'description': 'Not engaged at week 2 and still not engaged at week 8.\n\nRandomized to receive no further study intervention.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.57', 'spread': '0.50', 'groupId': 'OG001'}, {'value': '0.37', 'spread': '0.49', 'groupId': 'OG002'}, {'value': '0.46', 'spread': '0.51', 'groupId': 'OG003'}, {'value': '0.41', 'spread': '0.50', 'groupId': 'OG004'}, {'value': '0.60', 'spread': '0.50', 'groupId': 'OG005'}, {'value': '0.63', 'spread': '0.49', 'groupId': 'OG006'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 2 (weeks 5 - 8 post baseline)', 'description': 'Days of any drinking in previous month, as reported on Time Line Follow Back. This is a dichotomous measure, so the means that are reported are the percentage of people who have had any days of drinking during the follow up period specified. In other words, 0.57 indicates that 57% of the sample drank in the follow up period.', 'unitOfMeasure': 'proportion of participants', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed represents the number that were available to provide research data. Those participants who were engaged and remained engaged in treatment were not included in these analyses.'}, {'type': 'PRIMARY', 'title': 'Any Drinking Days in Previous Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}, {'value': '29', 'groupId': 'OG005'}, {'value': '34', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Engaged', 'description': 'Engaged at week 2 and remained engaged throughout the 8 weeks of study participation.\n\nThis group did not receive any treatment intervention.'}, {'id': 'OG001', 'title': 'MI-PC Non-engaged at 2 Weeks', 'description': 'Participants start at IOP, but at 2 weeks are not engaged. Randomized to treatment choice:\n\nMotivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.\n\nTelephone counseling: one telephone counseling session per week for 10 weeks.\n\nCognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.\n\nMedication management: Prescription for naltrexone\n\nIntensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day.'}, {'id': 'OG002', 'title': 'MI-IOP Non-Engaged at 2 Weeks', 'description': 'Participants begin at IOP, but at 2 weeks are determined to no longer be engaged.\n\nRandomized to IOP\n\nMotivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.'}, {'id': 'OG003', 'title': 'MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks', 'description': 'Randomized to treatment choice, but remain attending treatment as usual then dropped out of treatment after randomization.\n\nMotivational Interviewing: 2 sessions at time of disengagement presenting treatment choices to participants.\n\nTelephone counseling: one telephone counseling session per week for 10 weeks.\n\nCognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.\n\nMedication Management: Prescription for Naltrexone'}, {'id': 'OG004', 'title': 'MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks', 'description': 'Initially engaged at IOP, but become nonengaged in weeks 3 - 8.\n\nMotivational Interviewing: 2 sessions at time of disengagement.\n\nReturn to IOP therapy 3 times weekly for three hours a day'}, {'id': 'OG005', 'title': 'MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks', 'description': 'Began study in IOP but was nonengaged at week 2. Randomized to Patient Choice.\n\nMotivational Interviewing: 2 sessions at week 2 presenting treatment choices to participants.\n\nTelephone counseling: one telephone counseling session per week for 10 weeks.\n\nCognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.\n\nMedication Management: Prescription for Naltrexone'}, {'id': 'OG006', 'title': 'No Further Intervention', 'description': 'Not engaged at week 2 and still not engaged at week 8.\n\nRandomized to receive no further study intervention.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.58', 'spread': '0.50', 'groupId': 'OG001'}, {'value': '0.37', 'spread': '0.49', 'groupId': 'OG002'}, {'value': '0.57', 'spread': '0.50', 'groupId': 'OG003'}, {'value': '0.42', 'spread': '0.50', 'groupId': 'OG004'}, {'value': '0.72', 'spread': '0.45', 'groupId': 'OG005'}, {'value': '0.50', 'spread': '0.51', 'groupId': 'OG006'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 3 (weeks 9 - 12 post baseline)', 'description': 'Any drinking days during previous month, as reported on Time Line Follow Back. This is a dichotomous measure, so the means that are reported are the percentage of people who have had any days of drinking during the follow up period specified. In other words, 0.57 indicates that 57% of the sample drank in the follow up period.', 'unitOfMeasure': 'proportion of participants', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed represents the number that were available to provide research data. Those participants who were engaged and remained engaged in treatment were not included in these analyses.'}, {'type': 'PRIMARY', 'title': 'Any Drinking', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}, {'value': '33', 'groupId': 'OG004'}, {'value': '24', 'groupId': 'OG005'}, {'value': '30', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Engaged', 'description': 'Engaged at week 2 and remained engaged throughout the 8 weeks of study participation.\n\nThis group did not receive any treatment intervention.'}, {'id': 'OG001', 'title': 'MI-PC Non-engaged at 2 Weeks', 'description': 'Participants start at IOP, but at 2 weeks are not engaged. Randomized to treatment choice:\n\nMotivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.\n\nTelephone counseling: one telephone counseling session per week for 10 weeks.\n\nCognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.\n\nMedication management: Prescription for naltrexone\n\nIntensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day.'}, {'id': 'OG002', 'title': 'MI-IOP Non-Engaged at 2 Weeks', 'description': 'Participants begin at IOP, but at 2 weeks are determined to no longer be engaged.\n\nRandomized to IOP\n\nMotivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.'}, {'id': 'OG003', 'title': 'MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks', 'description': 'Randomized to treatment choice, but remain attending treatment as usual then dropped out of treatment after randomization.\n\nMotivational Interviewing: 2 sessions at time of disengagement presenting treatment choices to participants.\n\nTelephone counseling: one telephone counseling session per week for 10 weeks.\n\nCognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.\n\nMedication Management: Prescription for Naltrexone'}, {'id': 'OG004', 'title': 'MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks', 'description': 'Initially engaged at IOP, but become nonengaged in weeks 3 - 8.\n\nMotivational Interviewing: 2 sessions at time of disengagement.\n\nReturn to IOP therapy 3 times weekly for three hours a day'}, {'id': 'OG005', 'title': 'MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks', 'description': 'Began study in IOP but was nonengaged at week 2. Randomized to Patient Choice.\n\nMotivational Interviewing: 2 sessions at week 2 presenting treatment choices to participants.\n\nTelephone counseling: one telephone counseling session per week for 10 weeks.\n\nCognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.\n\nMedication Management: Prescription for Naltrexone'}, {'id': 'OG006', 'title': 'No Further Intervention', 'description': 'Not engaged at week 2 and still not engaged at week 8.\n\nRandomized to receive no further study intervention.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.49', 'spread': '0.50', 'groupId': 'OG001'}, {'value': '0.26', 'spread': '0.44', 'groupId': 'OG002'}, {'value': '0.42', 'spread': '0.50', 'groupId': 'OG003'}, {'value': '0.30', 'spread': '0.47', 'groupId': 'OG004'}, {'value': '0.50', 'spread': '0.51', 'groupId': 'OG005'}, {'value': '0.47', 'spread': '0.51', 'groupId': 'OG006'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 4 (weeks 13 - 15 post baseline)', 'description': 'Any drinking at follow up, as reported on Time Line Follow Back. This is a dichotomous measure, so the means that are reported are the percentage of people who have had any days of drinking during the follow up period specified. In other words, 0.57 indicates that 57% of the sample drank in the follow up period.', 'unitOfMeasure': 'proportion of participants', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed represents the number that were available to provide research data. Those participants who were engaged and remained engaged in treatment were not included in these analyses.'}, {'type': 'PRIMARY', 'title': 'Any Drinking', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}, {'value': '33', 'groupId': 'OG004'}, {'value': '24', 'groupId': 'OG005'}, {'value': '30', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Engaged', 'description': 'Engaged at week 2 and remained engaged throughout the 8 weeks of study participation.\n\nThis group did not receive any treatment intervention.'}, {'id': 'OG001', 'title': 'MI-PC Non-engaged at 2 Weeks', 'description': 'Participants start at IOP, but at 2 weeks are not engaged. Randomized to treatment choice:\n\nMotivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.\n\nTelephone counseling: one telephone counseling session per week for 10 weeks.\n\nCognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.\n\nMedication management: Prescription for naltrexone\n\nIntensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day.'}, {'id': 'OG002', 'title': 'MI-IOP Non-Engaged at 2 Weeks', 'description': 'Participants begin at IOP, but at 2 weeks are determined to no longer be engaged.\n\nRandomized to IOP\n\nMotivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.'}, {'id': 'OG003', 'title': 'MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks', 'description': 'Randomized to treatment choice, but remain attending treatment as usual then dropped out of treatment after randomization.\n\nMotivational Interviewing: 2 sessions at time of disengagement presenting treatment choices to participants.\n\nTelephone counseling: one telephone counseling session per week for 10 weeks.\n\nCognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.\n\nMedication Management: Prescription for Naltrexone'}, {'id': 'OG004', 'title': 'MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks', 'description': 'Initially engaged at IOP, but become nonengaged in weeks 3 - 8.\n\nMotivational Interviewing: 2 sessions at time of disengagement.\n\nReturn to IOP therapy 3 times weekly for three hours a day'}, {'id': 'OG005', 'title': 'MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks', 'description': 'Began study in IOP but was nonengaged at week 2. Randomized to Patient Choice.\n\nMotivational Interviewing: 2 sessions at week 2 presenting treatment choices to participants.\n\nTelephone counseling: one telephone counseling session per week for 10 weeks.\n\nCognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.\n\nMedication Management: Prescription for Naltrexone'}, {'id': 'OG006', 'title': 'No Further Intervention', 'description': 'Not engaged at week 2 and still not engaged at week 8.\n\nRandomized to receive no further study intervention.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.51', 'spread': '0.50', 'groupId': 'OG001'}, {'value': '0.31', 'spread': '0.47', 'groupId': 'OG002'}, {'value': '0.42', 'spread': '0.50', 'groupId': 'OG003'}, {'value': '0.30', 'spread': '0.47', 'groupId': 'OG004'}, {'value': '0.42', 'spread': '0.50', 'groupId': 'OG005'}, {'value': '0.57', 'spread': '0.50', 'groupId': 'OG006'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 5 (weeks 16 - 20 post baseline)', 'description': 'Any drinking at follow up, as reported on Time Line Follow Back, This is a dichotomous measure, so the means that are reported are the percentage of people who have had any days of drinking during the follow up period specified. In other words, 0.57 indicates that 57% of the sample drank in the follow up period.', 'unitOfMeasure': 'proportion of participants', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed represents the number that were available to provide research data. Those participants who were engaged and remained engaged in treatment were not included in these analyses.'}, {'type': 'PRIMARY', 'title': 'Any Drinking', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}, {'value': '33', 'groupId': 'OG004'}, {'value': '24', 'groupId': 'OG005'}, {'value': '30', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Engaged', 'description': 'Engaged at week 2 and remained engaged throughout the 8 weeks of study participation.\n\nThis group did not receive any treatment intervention.'}, {'id': 'OG001', 'title': 'MI-PC Non-engaged at 2 Weeks', 'description': 'Participants start at IOP, but at 2 weeks are not engaged. Randomized to treatment choice:\n\nMotivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.\n\nTelephone counseling: one telephone counseling session per week for 10 weeks.\n\nCognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.\n\nMedication management: Prescription for naltrexone\n\nIntensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day.'}, {'id': 'OG002', 'title': 'MI-IOP Non-Engaged at 2 Weeks', 'description': 'Participants begin at IOP, but at 2 weeks are determined to no longer be engaged.\n\nRandomized to IOP\n\nMotivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.'}, {'id': 'OG003', 'title': 'MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks', 'description': 'Randomized to treatment choice, but remain attending treatment as usual then dropped out of treatment after randomization.\n\nMotivational Interviewing: 2 sessions at time of disengagement presenting treatment choices to participants.\n\nTelephone counseling: one telephone counseling session per week for 10 weeks.\n\nCognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.\n\nMedication Management: Prescription for Naltrexone'}, {'id': 'OG004', 'title': 'MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks', 'description': 'Initially engaged at IOP, but become nonengaged in weeks 3 - 8.\n\nMotivational Interviewing: 2 sessions at time of disengagement.\n\nReturn to IOP therapy 3 times weekly for three hours a day'}, {'id': 'OG005', 'title': 'MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks', 'description': 'Began study in IOP but was nonengaged at week 2. Randomized to Patient Choice.\n\nMotivational Interviewing: 2 sessions at week 2 presenting treatment choices to participants.\n\nTelephone counseling: one telephone counseling session per week for 10 weeks.\n\nCognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.\n\nMedication Management: Prescription for Naltrexone'}, {'id': 'OG006', 'title': 'No Further Intervention', 'description': 'Not engaged at week 2 and still not engaged at week 8.\n\nRandomized to receive no further study intervention.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.56', 'spread': '0.50', 'groupId': 'OG001'}, {'value': '0.31', 'spread': '0.47', 'groupId': 'OG002'}, {'value': '0.50', 'spread': '0.51', 'groupId': 'OG003'}, {'value': '0.27', 'spread': '0.45', 'groupId': 'OG004'}, {'value': '0.42', 'spread': '0.50', 'groupId': 'OG005'}, {'value': '0.63', 'spread': '0.49', 'groupId': 'OG006'}]}]}], 'analyses': [{'pValue': '0.0007', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.40', 'ciLowerLimit': '0.23', 'ciUpperLimit': '0.68', 'groupDescription': 'The statistical analyses used data from all follow up assessments.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.16', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.54', 'ciLowerLimit': '0.23', 'ciUpperLimit': '1.27', 'groupDescription': 'The statistical analyses used data from all follow up assessments.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.79', 'groupIds': ['OG005', 'OG006'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.12', 'ciLowerLimit': '0.48', 'ciUpperLimit': '2.60', 'groupDescription': 'The statistical analyses used data from all follow up assessments.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Month 6 (weeks 21 - 24 post baseline)', 'description': 'Any drinking at follow up, as reported on Time Line Follow Back. This is a dichotomous measure, so the means that are reported are the percentage of people who have had any days of drinking during the follow up period specified. In other words, 0.57 indicates that 57% of the sample drank in the follow up period.', 'unitOfMeasure': 'proportion of participants', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed represents the number that were available to provide research data. Those participants who were engaged and remained engaged in treatment were not included in these analyses.'}, {'type': 'PRIMARY', 'title': 'Percent Days Drinking', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}, {'value': '63', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}, {'value': '37', 'groupId': 'OG004'}, {'value': '30', 'groupId': 'OG005'}, {'value': '32', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Engaged', 'description': 'Engaged at week 2 and remained engaged throughout the 8 weeks of study participation.\n\nThis group did not receive any treatment intervention.'}, {'id': 'OG001', 'title': 'MI-PC Non-engaged at 2 Weeks', 'description': 'Participants start at IOP, but at 2 weeks are not engaged. Randomized to treatment choice:\n\nMotivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.\n\nTelephone counseling: one telephone counseling session per week for 10 weeks.\n\nCognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.\n\nMedication management: Prescription for naltrexone\n\nIntensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day.'}, {'id': 'OG002', 'title': 'MI-IOP Non-Engaged at 2 Weeks', 'description': 'Participants begin at IOP, but at 2 weeks are determined to no longer be engaged.\n\nRandomized to IOP\n\nMotivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.'}, {'id': 'OG003', 'title': 'MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks', 'description': 'Randomized to treatment choice, but remain attending treatment as usual then dropped out of treatment after randomization.\n\nMotivational Interviewing: 2 sessions at time of disengagement presenting treatment choices to participants.\n\nTelephone counseling: one telephone counseling session per week for 10 weeks.\n\nCognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.\n\nMedication Management: Prescription for Naltrexone'}, {'id': 'OG004', 'title': 'MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks', 'description': 'Initially engaged at IOP, but become nonengaged in weeks 3 - 8.\n\nMotivational Interviewing: 2 sessions at time of disengagement.\n\nReturn to IOP therapy 3 times weekly for three hours a day'}, {'id': 'OG005', 'title': 'MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks', 'description': 'Began study in IOP but was nonengaged at week 2. Randomized to Patient Choice.\n\nMotivational Interviewing: 2 sessions at week 2 presenting treatment choices to participants.\n\nTelephone counseling: one telephone counseling session per week for 10 weeks.\n\nCognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.\n\nMedication Management: Prescription for Naltrexone'}, {'id': 'OG006', 'title': 'No Further Intervention', 'description': 'Not engaged at week 2 and still not engaged at week 8.\n\nRandomized to receive no further study intervention.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.81', 'spread': '18.10', 'groupId': 'OG001'}, {'value': '12.93', 'spread': '26.81', 'groupId': 'OG002'}, {'value': '17.35', 'spread': '29.12', 'groupId': 'OG003'}, {'value': '8.11', 'spread': '15.12', 'groupId': 'OG004'}, {'value': '20.00', 'spread': '28.15', 'groupId': 'OG005'}, {'value': '17.30', 'spread': '25.80', 'groupId': 'OG006'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 2 (weeks 5 - 8 post baseline)', 'description': 'Percent days of any drinking at follow up, from Time Line Follow Back', 'unitOfMeasure': 'percentage of days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed represents the number that were available to provide research data. Those participants who were engaged and remained engaged in treatment were not included in these analyses.'}, {'type': 'PRIMARY', 'title': 'Percent Days Drinking', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}, {'value': '29', 'groupId': 'OG005'}, {'value': '34', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Engaged', 'description': 'Engaged at week 2 and remained engaged throughout the 8 weeks of study participation.\n\nThis group did not receive any treatment intervention.'}, {'id': 'OG001', 'title': 'MI-PC Non-engaged at 2 Weeks', 'description': 'Participants start at IOP, but at 2 weeks are not engaged. Randomized to treatment choice:\n\nMotivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.\n\nTelephone counseling: one telephone counseling session per week for 10 weeks.\n\nCognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.\n\nMedication management: Prescription for naltrexone\n\nIntensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day.'}, {'id': 'OG002', 'title': 'MI-IOP Non-Engaged at 2 Weeks', 'description': 'Participants begin at IOP, but at 2 weeks are determined to no longer be engaged.\n\nRandomized to IOP\n\nMotivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.'}, {'id': 'OG003', 'title': 'MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks', 'description': 'Randomized to treatment choice, but remain attending treatment as usual then dropped out of treatment after randomization.\n\nMotivational Interviewing: 2 sessions at time of disengagement presenting treatment choices to participants.\n\nTelephone counseling: one telephone counseling session per week for 10 weeks.\n\nCognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.\n\nMedication Management: Prescription for Naltrexone'}, {'id': 'OG004', 'title': 'MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks', 'description': 'Initially engaged at IOP, but become nonengaged in weeks 3 - 8.\n\nMotivational Interviewing: 2 sessions at time of disengagement.\n\nReturn to IOP therapy 3 times weekly for three hours a day'}, {'id': 'OG005', 'title': 'MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks', 'description': 'Began study in IOP but was nonengaged at week 2. Randomized to Patient Choice.\n\nMotivational Interviewing: 2 sessions at week 2 presenting treatment choices to participants.\n\nTelephone counseling: one telephone counseling session per week for 10 weeks.\n\nCognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.\n\nMedication Management: Prescription for Naltrexone'}, {'id': 'OG006', 'title': 'No Further Intervention', 'description': 'Not engaged at week 2 and still not engaged at week 8.\n\nRandomized to receive no further study intervention.'}], 'classes': [{'categories': [{'measurements': [{'value': '14.51', 'spread': '26.89', 'groupId': 'OG001'}, {'value': '9.10', 'spread': '21.68', 'groupId': 'OG002'}, {'value': '15.31', 'spread': '25.49', 'groupId': 'OG003'}, {'value': '8.23', 'spread': '15.24', 'groupId': 'OG004'}, {'value': '20.02', 'spread': '29.61', 'groupId': 'OG005'}, {'value': '11.66', 'spread': '23.50', 'groupId': 'OG006'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 3 (weeks 9 - 12 post baseline)', 'description': 'Percent days of any drinking at follow up, from Time Line Follow Back', 'unitOfMeasure': 'percentage of days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed represents the number that were available to provide research data. Those participants who were engaged and remained engaged in treatment were not included in these analyses.'}, {'type': 'PRIMARY', 'title': 'Percent Days Drinking', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}, {'value': '33', 'groupId': 'OG004'}, {'value': '23', 'groupId': 'OG005'}, {'value': '30', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Engaged', 'description': 'Engaged at week 2 and remained engaged throughout the 8 weeks of study participation.\n\nThis group did not receive any treatment intervention.'}, {'id': 'OG001', 'title': 'MI-PC Non-engaged at 2 Weeks', 'description': 'Participants start at IOP, but at 2 weeks are not engaged. Randomized to treatment choice:\n\nMotivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.\n\nTelephone counseling: one telephone counseling session per week for 10 weeks.\n\nCognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.\n\nMedication management: Prescription for naltrexone\n\nIntensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day.'}, {'id': 'OG002', 'title': 'MI-IOP Non-Engaged at 2 Weeks', 'description': 'Participants begin at IOP, but at 2 weeks are determined to no longer be engaged.\n\nRandomized to IOP\n\nMotivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.'}, {'id': 'OG003', 'title': 'MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks', 'description': 'Randomized to treatment choice, but remain attending treatment as usual then dropped out of treatment after randomization.\n\nMotivational Interviewing: 2 sessions at time of disengagement presenting treatment choices to participants.\n\nTelephone counseling: one telephone counseling session per week for 10 weeks.\n\nCognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.\n\nMedication Management: Prescription for Naltrexone'}, {'id': 'OG004', 'title': 'MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks', 'description': 'Initially engaged at IOP, but become nonengaged in weeks 3 - 8.\n\nMotivational Interviewing: 2 sessions at time of disengagement.\n\nReturn to IOP therapy 3 times weekly for three hours a day'}, {'id': 'OG005', 'title': 'MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks', 'description': 'Began study in IOP but was nonengaged at week 2. Randomized to Patient Choice.\n\nMotivational Interviewing: 2 sessions at week 2 presenting treatment choices to participants.\n\nTelephone counseling: one telephone counseling session per week for 10 weeks.\n\nCognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.\n\nMedication Management: Prescription for Naltrexone'}, {'id': 'OG006', 'title': 'No Further Intervention', 'description': 'Not engaged at week 2 and still not engaged at week 8.\n\nRandomized to receive no further study intervention.'}], 'classes': [{'categories': [{'measurements': [{'value': '15.76', 'spread': '26.16', 'groupId': 'OG001'}, {'value': '8.96', 'spread': '24.65', 'groupId': 'OG002'}, {'value': '21.13', 'spread': '37.69', 'groupId': 'OG003'}, {'value': '13.42', 'spread': '29.38', 'groupId': 'OG004'}, {'value': '6.37', 'spread': '11.55', 'groupId': 'OG005'}, {'value': '18.81', 'spread': '31.37', 'groupId': 'OG006'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 4 (weeks 13 - 16 post baseline)', 'description': 'Percent days of any drinking at follow up, from Time Line Follow Back', 'unitOfMeasure': 'percentage of days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed represents the number that were available to provide research data. Those participants who were engaged and remained engaged in treatment were not included in these analyses.'}, {'type': 'PRIMARY', 'title': 'Percent Days Drinking', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}, {'value': '33', 'groupId': 'OG004'}, {'value': '23', 'groupId': 'OG005'}, {'value': '30', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Engaged', 'description': 'Engaged at week 2 and remained engaged throughout the 8 weeks of study participation.\n\nThis group did not receive any treatment intervention.'}, {'id': 'OG001', 'title': 'MI-PC Non-engaged at 2 Weeks', 'description': 'Participants start at IOP, but at 2 weeks are not engaged. Randomized to treatment choice:\n\nMotivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.\n\nTelephone counseling: one telephone counseling session per week for 10 weeks.\n\nCognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.\n\nMedication management: Prescription for naltrexone\n\nIntensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day.'}, {'id': 'OG002', 'title': 'MI-IOP Non-Engaged at 2 Weeks', 'description': 'Participants begin at IOP, but at 2 weeks are determined to no longer be engaged.\n\nRandomized to IOP\n\nMotivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.'}, {'id': 'OG003', 'title': 'MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks', 'description': 'Randomized to treatment choice, but remain attending treatment as usual then dropped out of treatment after randomization.\n\nMotivational Interviewing: 2 sessions at time of disengagement presenting treatment choices to participants.\n\nTelephone counseling: one telephone counseling session per week for 10 weeks.\n\nCognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.\n\nMedication Management: Prescription for Naltrexone'}, {'id': 'OG004', 'title': 'MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks', 'description': 'Initially engaged at IOP, but become nonengaged in weeks 3 - 8.\n\nMotivational Interviewing: 2 sessions at time of disengagement.\n\nReturn to IOP therapy 3 times weekly for three hours a day'}, {'id': 'OG005', 'title': 'MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks', 'description': 'Began study in IOP but was nonengaged at week 2. Randomized to Patient Choice.\n\nMotivational Interviewing: 2 sessions at week 2 presenting treatment choices to participants.\n\nTelephone counseling: one telephone counseling session per week for 10 weeks.\n\nCognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.\n\nMedication Management: Prescription for Naltrexone'}, {'id': 'OG006', 'title': 'No Further Intervention', 'description': 'Not engaged at week 2 and still not engaged at week 8.\n\nRandomized to receive no further study intervention.'}], 'classes': [{'categories': [{'measurements': [{'value': '18.37', 'spread': '29.86', 'groupId': 'OG001'}, {'value': '8.22', 'spread': '19.78', 'groupId': 'OG002'}, {'value': '20.24', 'spread': '33.31', 'groupId': 'OG003'}, {'value': '11.47', 'spread': '28.57', 'groupId': 'OG004'}, {'value': '6.99', 'spread': '15.09', 'groupId': 'OG005'}, {'value': '20.60', 'spread': '27.90', 'groupId': 'OG006'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 5 (weeks 17 - 20 post baseline)', 'description': 'Percent days of any drinking at follow up, fromTime Line Follow Back', 'unitOfMeasure': 'percentage of days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed represents the number that were available to provide research data. Those participants who were engaged and remained engaged in treatment were not included in these analyses.'}, {'type': 'PRIMARY', 'title': 'Percent Days Drinking', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}, {'value': '33', 'groupId': 'OG004'}, {'value': '23', 'groupId': 'OG005'}, {'value': '30', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Engaged', 'description': 'Engaged at week 2 and remained engaged throughout the 8 weeks of study participation.\n\nThis group did not receive any treatment intervention.'}, {'id': 'OG001', 'title': 'MI-PC Non-engaged at 2 Weeks', 'description': 'Participants start at IOP, but at 2 weeks are not engaged. Randomized to treatment choice:\n\nMotivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.\n\nTelephone counseling: one telephone counseling session per week for 10 weeks.\n\nCognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.\n\nMedication management: Prescription for naltrexone\n\nIntensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day.'}, {'id': 'OG002', 'title': 'MI-IOP Non-Engaged at 2 Weeks', 'description': 'Participants begin at IOP, but at 2 weeks are determined to no longer be engaged.\n\nRandomized to IOP\n\nMotivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.'}, {'id': 'OG003', 'title': 'MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks', 'description': 'Randomized to treatment choice, but remain attending treatment as usual then dropped out of treatment after randomization.\n\nMotivational Interviewing: 2 sessions at time of disengagement presenting treatment choices to participants.\n\nTelephone counseling: one telephone counseling session per week for 10 weeks.\n\nCognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.\n\nMedication Management: Prescription for Naltrexone'}, {'id': 'OG004', 'title': 'MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks', 'description': 'Initially engaged at IOP, but become nonengaged in weeks 3 - 8.\n\nMotivational Interviewing: 2 sessions at time of disengagement.\n\nReturn to IOP therapy 3 times weekly for three hours a day'}, {'id': 'OG005', 'title': 'MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks', 'description': 'Began study in IOP but was nonengaged at week 2. Randomized to Patient Choice.\n\nMotivational Interviewing: 2 sessions at week 2 presenting treatment choices to participants.\n\nTelephone counseling: one telephone counseling session per week for 10 weeks.\n\nCognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.\n\nMedication Management: Prescription for Naltrexone'}, {'id': 'OG006', 'title': 'No Further Intervention', 'description': 'Not engaged at week 2 and still not engaged at week 8.\n\nRandomized to receive no further study intervention.'}], 'classes': [{'categories': [{'measurements': [{'value': '14.75', 'spread': '26.05', 'groupId': 'OG001'}, {'value': '5.66', 'spread': '16.61', 'groupId': 'OG002'}, {'value': '19.05', 'spread': '34.19', 'groupId': 'OG003'}, {'value': '8.77', 'spread': '24.42', 'groupId': 'OG004'}, {'value': '8.70', 'spread': '21.67', 'groupId': 'OG005'}, {'value': '15.38', 'spread': '23.06', 'groupId': 'OG006'}]}]}], 'analyses': [{'pValue': '0.009', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.08', 'ciLowerLimit': '-1.87', 'ciUpperLimit': '-0.29', 'groupDescription': 'The statistical analyses used data from all follow up assessments.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.23', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.84', 'ciLowerLimit': '-2.20', 'ciUpperLimit': '0.52', 'groupDescription': 'The statistical analyses used data from all follow up assessments.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.58', 'groupIds': ['OG005', 'OG006'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.34', 'ciLowerLimit': '-1.52', 'ciUpperLimit': '0.85', 'groupDescription': 'The statistical analyses used data from all follow up assessments.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Month 6 (weeks 21 - 24)', 'description': 'Percent days of any drinking at follow up, from Time Line Follow Back', 'unitOfMeasure': 'percentage of days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed represents the number that were available to provide research data. Those participants who were engaged and remained engaged in treatment were not included in these analyses.'}, {'type': 'PRIMARY', 'title': 'Any Heavy Drinking Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}, {'value': '63', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}, {'value': '37', 'groupId': 'OG004'}, {'value': '30', 'groupId': 'OG005'}, {'value': '32', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Engaged', 'description': 'Engaged at week 2 and remained engaged throughout the 8 weeks of study participation.\n\nThis group did not receive any treatment intervention.'}, {'id': 'OG001', 'title': 'MI-PC Non-engaged at 2 Weeks', 'description': 'Participants start at IOP, but at 2 weeks are not engaged. Randomized to treatment choice:\n\nMotivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.\n\nTelephone counseling: one telephone counseling session per week for 10 weeks.\n\nCognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.\n\nMedication management: Prescription for naltrexone\n\nIntensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day.'}, {'id': 'OG002', 'title': 'MI-IOP Non-Engaged at 2 Weeks', 'description': 'Participants begin at IOP, but at 2 weeks are determined to no longer be engaged.\n\nRandomized to IOP\n\nMotivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.'}, {'id': 'OG003', 'title': 'MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks', 'description': 'Randomized to treatment choice, but remain attending treatment as usual then dropped out of treatment after randomization.\n\nMotivational Interviewing: 2 sessions at time of disengagement presenting treatment choices to participants.\n\nTelephone counseling: one telephone counseling session per week for 10 weeks.\n\nCognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.\n\nMedication Management: Prescription for Naltrexone'}, {'id': 'OG004', 'title': 'MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks', 'description': 'Initially engaged at IOP, but become nonengaged in weeks 3 - 8.\n\nMotivational Interviewing: 2 sessions at time of disengagement.\n\nReturn to IOP therapy 3 times weekly for three hours a day'}, {'id': 'OG005', 'title': 'MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks', 'description': 'Began study in IOP but was nonengaged at week 2. Randomized to Patient Choice.\n\nMotivational Interviewing: 2 sessions at week 2 presenting treatment choices to participants.\n\nTelephone counseling: one telephone counseling session per week for 10 weeks.\n\nCognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.\n\nMedication Management: Prescription for Naltrexone'}, {'id': 'OG006', 'title': 'No Further Intervention', 'description': 'Not engaged at week 2 and still not engaged at week 8.\n\nRandomized to receive no further study intervention.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.49', 'spread': '0.50', 'groupId': 'OG001'}, {'value': '0.24', 'spread': '0.43', 'groupId': 'OG002'}, {'value': '0.36', 'spread': '0.49', 'groupId': 'OG003'}, {'value': '0.24', 'spread': '0.43', 'groupId': 'OG004'}, {'value': '0.47', 'spread': '0.51', 'groupId': 'OG005'}, {'value': '0.34', 'spread': '0.48', 'groupId': 'OG006'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 2 (weeks 5 - 8 post baseline)', 'description': 'days of five or more drinks per drinking day for men, four or more drinks per drinking day for women, at follow up, from Time Line Follow Back. This is a dichotomous measure, so the means that are reported are the percentage of people who have had any days of heavy drinking during the follow up period specified. In other words, 0.57 indicates that 57% of the sample engaged in heavy drinking in the follow up period.', 'unitOfMeasure': 'proportion of participants', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed represents the number that were available to provide research data. Those participants who were engaged and remained engaged in treatment were not included in these analyses.'}, {'type': 'PRIMARY', 'title': 'Any Heavy Drinking Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}, {'value': '29', 'groupId': 'OG005'}, {'value': '34', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Engaged', 'description': 'Engaged at week 2 and remained engaged throughout the 8 weeks of study participation.\n\nThis group did not receive any treatment intervention.'}, {'id': 'OG001', 'title': 'MI-PC Non-engaged at 2 Weeks', 'description': 'Participants start at IOP, but at 2 weeks are not engaged. Randomized to treatment choice:\n\nMotivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.\n\nTelephone counseling: one telephone counseling session per week for 10 weeks.\n\nCognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.\n\nMedication management: Prescription for naltrexone\n\nIntensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day.'}, {'id': 'OG002', 'title': 'MI-IOP Non-Engaged at 2 Weeks', 'description': 'Participants begin at IOP, but at 2 weeks are determined to no longer be engaged.\n\nRandomized to IOP\n\nMotivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.'}, {'id': 'OG003', 'title': 'MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks', 'description': 'Randomized to treatment choice, but remain attending treatment as usual then dropped out of treatment after randomization.\n\nMotivational Interviewing: 2 sessions at time of disengagement presenting treatment choices to participants.\n\nTelephone counseling: one telephone counseling session per week for 10 weeks.\n\nCognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.\n\nMedication Management: Prescription for Naltrexone'}, {'id': 'OG004', 'title': 'MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks', 'description': 'Initially engaged at IOP, but become nonengaged in weeks 3 - 8.\n\nMotivational Interviewing: 2 sessions at time of disengagement.\n\nReturn to IOP therapy 3 times weekly for three hours a day'}, {'id': 'OG005', 'title': 'MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks', 'description': 'Began study in IOP but was nonengaged at week 2. Randomized to Patient Choice.\n\nMotivational Interviewing: 2 sessions at week 2 presenting treatment choices to participants.\n\nTelephone counseling: one telephone counseling session per week for 10 weeks.\n\nCognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.\n\nMedication Management: Prescription for Naltrexone'}, {'id': 'OG006', 'title': 'No Further Intervention', 'description': 'Not engaged at week 2 and still not engaged at week 8.\n\nRandomized to receive no further study intervention.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.44', 'spread': '0.50', 'groupId': 'OG001'}, {'value': '0.26', 'spread': '0.44', 'groupId': 'OG002'}, {'value': '0.36', 'spread': '0.49', 'groupId': 'OG003'}, {'value': '0.33', 'spread': '0.48', 'groupId': 'OG004'}, {'value': '0.55', 'spread': '0.51', 'groupId': 'OG005'}, {'value': '0.32', 'spread': '0.47', 'groupId': 'OG006'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 3 (weeks 9 - 12 post baseline)', 'description': 'five or more drinks per drinking day for men, four or more drinks per drinking day for women, at follow up, from Time Line Follow Back. This is a dichotomous measure, so the means that are reported are the percentage of people who have had any days of heavy drinking during the follow up period specified. In other words, 0.57 indicates that 57% of the sample engaged in heavy drinking in the follow up period.', 'unitOfMeasure': 'proportion of participants', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed represents the number that were available to provide research data. Those participants who were engaged and remained engaged in treatment were not included in these analyses.'}, {'type': 'PRIMARY', 'title': 'Any Heavy Drinking Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}, {'value': '33', 'groupId': 'OG004'}, {'value': '24', 'groupId': 'OG005'}, {'value': '30', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Engaged', 'description': 'Engaged at week 2 and remained engaged throughout the 8 weeks of study participation.\n\nThis group did not receive any treatment intervention.'}, {'id': 'OG001', 'title': 'MI-PC Non-engaged at 2 Weeks', 'description': 'Participants start at IOP, but at 2 weeks are not engaged. Randomized to treatment choice:\n\nMotivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.\n\nTelephone counseling: one telephone counseling session per week for 10 weeks.\n\nCognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.\n\nMedication management: Prescription for naltrexone\n\nIntensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day.'}, {'id': 'OG002', 'title': 'MI-IOP Non-Engaged at 2 Weeks', 'description': 'Participants begin at IOP, but at 2 weeks are determined to no longer be engaged.\n\nRandomized to IOP\n\nMotivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.'}, {'id': 'OG003', 'title': 'MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks', 'description': 'Randomized to treatment choice, but remain attending treatment as usual then dropped out of treatment after randomization.\n\nMotivational Interviewing: 2 sessions at time of disengagement presenting treatment choices to participants.\n\nTelephone counseling: one telephone counseling session per week for 10 weeks.\n\nCognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.\n\nMedication Management: Prescription for Naltrexone'}, {'id': 'OG004', 'title': 'MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks', 'description': 'Initially engaged at IOP, but become nonengaged in weeks 3 - 8.\n\nMotivational Interviewing: 2 sessions at time of disengagement.\n\nReturn to IOP therapy 3 times weekly for three hours a day'}, {'id': 'OG005', 'title': 'MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks', 'description': 'Began study in IOP but was nonengaged at week 2. Randomized to Patient Choice.\n\nMotivational Interviewing: 2 sessions at week 2 presenting treatment choices to participants.\n\nTelephone counseling: one telephone counseling session per week for 10 weeks.\n\nCognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.\n\nMedication Management: Prescription for Naltrexone'}, {'id': 'OG006', 'title': 'No Further Intervention', 'description': 'Not engaged at week 2 and still not engaged at week 8.\n\nRandomized to receive no further study intervention.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.37', 'spread': '0.49', 'groupId': 'OG001'}, {'value': '0.15', 'spread': '0.36', 'groupId': 'OG002'}, {'value': '0.38', 'spread': '0.49', 'groupId': 'OG003'}, {'value': '0.24', 'spread': '0.44', 'groupId': 'OG004'}, {'value': '0.38', 'spread': '0.49', 'groupId': 'OG005'}, {'value': '0.27', 'spread': '0.45', 'groupId': 'OG006'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 4 (weeks 13 - 16 post baseline)', 'description': 'five or more drinks per drinking day for men, four or more drinks per drinking day for women at follow up, from Time Line Follow Back. This is a dichotomous measure, so the means that are reported are the percentage of people who have had any days of heavy drinking during the follow up period specified. In other words, 0.57 indicates that 57% of the sample engaged in heavy drinking in the follow up period.', 'unitOfMeasure': 'proportion of participants', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed represents the number that were available to provide research data. Those participants who were engaged and remained engaged in treatment were not included in these analyses.'}, {'type': 'PRIMARY', 'title': 'Any Heavy Drinking Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}, {'value': '33', 'groupId': 'OG004'}, {'value': '24', 'groupId': 'OG005'}, {'value': '30', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Engaged', 'description': 'Engaged at week 2 and remained engaged throughout the 8 weeks of study participation.\n\nThis group did not receive any treatment intervention.'}, {'id': 'OG001', 'title': 'MI-PC Non-engaged at 2 Weeks', 'description': 'Participants start at IOP, but at 2 weeks are not engaged. Randomized to treatment choice:\n\nMotivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.\n\nTelephone counseling: one telephone counseling session per week for 10 weeks.\n\nCognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.\n\nMedication management: Prescription for naltrexone\n\nIntensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day.'}, {'id': 'OG002', 'title': 'MI-IOP Non-Engaged at 2 Weeks', 'description': 'Participants begin at IOP, but at 2 weeks are determined to no longer be engaged.\n\nRandomized to IOP\n\nMotivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.'}, {'id': 'OG003', 'title': 'MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks', 'description': 'Randomized to treatment choice, but remain attending treatment as usual then dropped out of treatment after randomization.\n\nMotivational Interviewing: 2 sessions at time of disengagement presenting treatment choices to participants.\n\nTelephone counseling: one telephone counseling session per week for 10 weeks.\n\nCognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.\n\nMedication Management: Prescription for Naltrexone'}, {'id': 'OG004', 'title': 'MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks', 'description': 'Initially engaged at IOP, but become nonengaged in weeks 3 - 8.\n\nMotivational Interviewing: 2 sessions at time of disengagement.\n\nReturn to IOP therapy 3 times weekly for three hours a day'}, {'id': 'OG005', 'title': 'MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks', 'description': 'Began study in IOP but was nonengaged at week 2. Randomized to Patient Choice.\n\nMotivational Interviewing: 2 sessions at week 2 presenting treatment choices to participants.\n\nTelephone counseling: one telephone counseling session per week for 10 weeks.\n\nCognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.\n\nMedication Management: Prescription for Naltrexone'}, {'id': 'OG006', 'title': 'No Further Intervention', 'description': 'Not engaged at week 2 and still not engaged at week 8.\n\nRandomized to receive no further study intervention.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.37', 'spread': '0.49', 'groupId': 'OG001'}, {'value': '0.19', 'spread': '0.39', 'groupId': 'OG002'}, {'value': '0.38', 'spread': '0.49', 'groupId': 'OG003'}, {'value': '0.24', 'spread': '0.44', 'groupId': 'OG004'}, {'value': '0.25', 'spread': '0.44', 'groupId': 'OG005'}, {'value': '0.33', 'spread': '0.48', 'groupId': 'OG006'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 5 (weeks 17 to 20 post baseline)', 'description': 'five or more drinks per day for men, four or more drinks per day for women, from Time Line Follow Back. This is a dichotomous measure, so the means that are reported are the percentage of people who have had any days of heavy drinking during the follow up period specified. In other words, 0.57 indicates that 57% of the sample engaged in heavy drinking in the follow up period.', 'unitOfMeasure': 'proportion of participants', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed represents the number that were available to provide research data. Those participants who were engaged and remained engaged in treatment were not included in these analyses.'}, {'type': 'PRIMARY', 'title': 'Any Heavy Drinking Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}, {'value': '33', 'groupId': 'OG004'}, {'value': '24', 'groupId': 'OG005'}, {'value': '30', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Engaged', 'description': 'Engaged at week 2 and remained engaged throughout the 8 weeks of study participation.\n\nThis group did not receive any treatment intervention.'}, {'id': 'OG001', 'title': 'MI-PC Non-engaged at 2 Weeks', 'description': 'Participants start at IOP, but at 2 weeks are not engaged. Randomized to treatment choice:\n\nMotivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.\n\nTelephone counseling: one telephone counseling session per week for 10 weeks.\n\nCognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.\n\nMedication management: Prescription for naltrexone\n\nIntensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day.'}, {'id': 'OG002', 'title': 'MI-IOP Non-Engaged at 2 Weeks', 'description': 'Participants begin at IOP, but at 2 weeks are determined to no longer be engaged.\n\nRandomized to IOP\n\nMotivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.'}, {'id': 'OG003', 'title': 'MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks', 'description': 'Randomized to treatment choice, but remain attending treatment as usual then dropped out of treatment after randomization.\n\nMotivational Interviewing: 2 sessions at time of disengagement presenting treatment choices to participants.\n\nTelephone counseling: one telephone counseling session per week for 10 weeks.\n\nCognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.\n\nMedication Management: Prescription for Naltrexone'}, {'id': 'OG004', 'title': 'MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks', 'description': 'Initially engaged at IOP, but become nonengaged in weeks 3 - 8.\n\nMotivational Interviewing: 2 sessions at time of disengagement.\n\nReturn to IOP therapy 3 times weekly for three hours a day'}, {'id': 'OG005', 'title': 'MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks', 'description': 'Began study in IOP but was nonengaged at week 2. Randomized to Patient Choice.\n\nMotivational Interviewing: 2 sessions at week 2 presenting treatment choices to participants.\n\nTelephone counseling: one telephone counseling session per week for 10 weeks.\n\nCognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.\n\nMedication Management: Prescription for Naltrexone'}, {'id': 'OG006', 'title': 'No Further Intervention', 'description': 'Not engaged at week 2 and still not engaged at week 8.\n\nRandomized to receive no further study intervention.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.43', 'spread': '0.50', 'groupId': 'OG001'}, {'value': '0.17', 'spread': '0.38', 'groupId': 'OG002'}, {'value': '0.38', 'spread': '0.49', 'groupId': 'OG003'}, {'value': '0.21', 'spread': '0.42', 'groupId': 'OG004'}, {'value': '0.25', 'spread': '0.44', 'groupId': 'OG005'}, {'value': '0.37', 'spread': '0.49', 'groupId': 'OG006'}]}]}], 'analyses': [{'pValue': '0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.33', 'ciLowerLimit': '0.19', 'ciUpperLimit': '0.58', 'groupDescription': 'The statistical analyses used data from all follow up assessments.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.36', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.67', 'ciLowerLimit': '0.29', 'ciUpperLimit': '1.54', 'groupDescription': 'The statistical analyses used data from all follow up assessments.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.45', 'groupIds': ['OG005', 'OG006'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.43', 'ciLowerLimit': '0.58', 'ciUpperLimit': '3.54', 'groupDescription': 'The statistical analyses used data from all follow up assessments.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Month 6 (weeks 21 - 24 post baseline)', 'description': 'five or more drinks per day for men, four or more drinks per day for women, from Time Line Follow Back. This is a dichotomous measure, so the means that are reported are the percentage of people who have had any days of heavy drinking during the follow up period specified. In other words, 0.57 indicates that 57% of the sample engaged in heavy drinking in the follow up period.', 'unitOfMeasure': 'proportion of participants', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed represents the number that were available to provide research data. Those participants who were engaged and remained engaged in treatment were not included in these analyses.'}, {'type': 'PRIMARY', 'title': 'Percent Days Heavy Drinking', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}, {'value': '63', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}, {'value': '37', 'groupId': 'OG004'}, {'value': '30', 'groupId': 'OG005'}, {'value': '32', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Engaged', 'description': 'Engaged at week 2 and remained engaged throughout the 8 weeks of study participation.\n\nThis group did not receive any treatment intervention.'}, {'id': 'OG001', 'title': 'MI-PC Non-engaged at 2 Weeks', 'description': 'Participants start at IOP, but at 2 weeks are not engaged. Randomized to treatment choice:\n\nMotivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.\n\nTelephone counseling: one telephone counseling session per week for 10 weeks.\n\nCognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.\n\nMedication management: Prescription for naltrexone\n\nIntensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day.'}, {'id': 'OG002', 'title': 'MI-IOP Non-Engaged at 2 Weeks', 'description': 'Participants begin at IOP, but at 2 weeks are determined to no longer be engaged.\n\nRandomized to IOP\n\nMotivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.'}, {'id': 'OG003', 'title': 'MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks', 'description': 'Randomized to treatment choice, but remain attending treatment as usual then dropped out of treatment after randomization.\n\nMotivational Interviewing: 2 sessions at time of disengagement presenting treatment choices to participants.\n\nTelephone counseling: one telephone counseling session per week for 10 weeks.\n\nCognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.\n\nMedication Management: Prescription for Naltrexone'}, {'id': 'OG004', 'title': 'MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks', 'description': 'Initially engaged at IOP, but become nonengaged in weeks 3 - 8.\n\nMotivational Interviewing: 2 sessions at time of disengagement.\n\nReturn to IOP therapy 3 times weekly for three hours a day'}, {'id': 'OG005', 'title': 'MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks', 'description': 'Began study in IOP but was nonengaged at week 2. Randomized to Patient Choice.\n\nMotivational Interviewing: 2 sessions at week 2 presenting treatment choices to participants.\n\nTelephone counseling: one telephone counseling session per week for 10 weeks.\n\nCognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.\n\nMedication Management: Prescription for Naltrexone'}, {'id': 'OG006', 'title': 'No Further Intervention', 'description': 'Not engaged at week 2 and still not engaged at week 8.\n\nRandomized to receive no further study intervention.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.73', 'spread': '18.28', 'groupId': 'OG001'}, {'value': '7.14', 'spread': '20.11', 'groupId': 'OG002'}, {'value': '10.59', 'spread': '22.13', 'groupId': 'OG003'}, {'value': '6.37', 'spread': '14.85', 'groupId': 'OG004'}, {'value': '12.98', 'spread': '22.48', 'groupId': 'OG005'}, {'value': '10.49', 'spread': '21.16', 'groupId': 'OG006'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 2 (weeks 5 - 8 post baseline)', 'description': 'Percent days heavy drinking at follow up, from Time Line Follow Back\n\n\\*heavy drinking is defined as five or more drinks per day for men, four or more for women', 'unitOfMeasure': 'percentage of days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed represents the number that were available to provide research data. Those participants who were engaged and remained engaged in treatment were not included in these analyses.'}, {'type': 'PRIMARY', 'title': 'Percent Days Heavy Drinking', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}, {'value': '29', 'groupId': 'OG005'}, {'value': '34', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Engaged', 'description': 'Engaged at week 2 and remained engaged throughout the 8 weeks of study participation.\n\nThis group did not receive any treatment intervention.'}, {'id': 'OG001', 'title': 'MI-PC Non-engaged at 2 Weeks', 'description': 'Participants start at IOP, but at 2 weeks are not engaged. Randomized to treatment choice:\n\nMotivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.\n\nTelephone counseling: one telephone counseling session per week for 10 weeks.\n\nCognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.\n\nMedication management: Prescription for naltrexone\n\nIntensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day.'}, {'id': 'OG002', 'title': 'MI-IOP Non-Engaged at 2 Weeks', 'description': 'Participants begin at IOP, but at 2 weeks are determined to no longer be engaged.\n\nRandomized to IOP\n\nMotivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.'}, {'id': 'OG003', 'title': 'MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks', 'description': 'Randomized to treatment choice, but remain attending treatment as usual then dropped out of treatment after randomization.\n\nMotivational Interviewing: 2 sessions at time of disengagement presenting treatment choices to participants.\n\nTelephone counseling: one telephone counseling session per week for 10 weeks.\n\nCognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.\n\nMedication Management: Prescription for Naltrexone'}, {'id': 'OG004', 'title': 'MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks', 'description': 'Initially engaged at IOP, but become nonengaged in weeks 3 - 8.\n\nMotivational Interviewing: 2 sessions at time of disengagement.\n\nReturn to IOP therapy 3 times weekly for three hours a day'}, {'id': 'OG005', 'title': 'MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks', 'description': 'Began study in IOP but was nonengaged at week 2. Randomized to Patient Choice.\n\nMotivational Interviewing: 2 sessions at week 2 presenting treatment choices to participants.\n\nTelephone counseling: one telephone counseling session per week for 10 weeks.\n\nCognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.\n\nMedication Management: Prescription for Naltrexone'}, {'id': 'OG006', 'title': 'No Further Intervention', 'description': 'Not engaged at week 2 and still not engaged at week 8.\n\nRandomized to receive no further study intervention.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.58', 'spread': '22.61', 'groupId': 'OG001'}, {'value': '6.05', 'spread': '17.92', 'groupId': 'OG002'}, {'value': '12.37', 'spread': '24.33', 'groupId': 'OG003'}, {'value': '5.65', 'spread': '14.09', 'groupId': 'OG004'}, {'value': '14.16', 'spread': '24.53', 'groupId': 'OG005'}, {'value': '3.99', 'spread': '9.04', 'groupId': 'OG006'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 3 (weeks 9 - 12 post baseline)', 'description': 'Percent days heavy drinking at follow up, from Time Line Follow Back\n\n\\* heavy drinking is defined as five or more drinks per day for men, four or more for women.', 'unitOfMeasure': 'percentage of days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed represents the number that were available to provide research data. Those participants who were engaged and remained engaged in treatment were not included in these analyses.'}, {'type': 'PRIMARY', 'title': 'Percent Days Heavy Drinking', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}, {'value': '33', 'groupId': 'OG004'}, {'value': '23', 'groupId': 'OG005'}, {'value': '30', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Engaged', 'description': 'Engaged at week 2 and remained engaged throughout the 8 weeks of study participation.\n\nThis group did not receive any treatment intervention.'}, {'id': 'OG001', 'title': 'MI-PC Non-engaged at 2 Weeks', 'description': 'Participants start at IOP, but at 2 weeks are not engaged. Randomized to treatment choice:\n\nMotivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.\n\nTelephone counseling: one telephone counseling session per week for 10 weeks.\n\nCognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.\n\nMedication management: Prescription for naltrexone\n\nIntensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day.'}, {'id': 'OG002', 'title': 'MI-IOP Non-Engaged at 2 Weeks', 'description': 'Participants begin at IOP, but at 2 weeks are determined to no longer be engaged.\n\nRandomized to IOP\n\nMotivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.'}, {'id': 'OG003', 'title': 'MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks', 'description': 'Randomized to treatment choice, but remain attending treatment as usual then dropped out of treatment after randomization.\n\nMotivational Interviewing: 2 sessions at time of disengagement presenting treatment choices to participants.\n\nTelephone counseling: one telephone counseling session per week for 10 weeks.\n\nCognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.\n\nMedication Management: Prescription for Naltrexone'}, {'id': 'OG004', 'title': 'MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks', 'description': 'Initially engaged at IOP, but become nonengaged in weeks 3 - 8.\n\nMotivational Interviewing: 2 sessions at time of disengagement.\n\nReturn to IOP therapy 3 times weekly for three hours a day'}, {'id': 'OG005', 'title': 'MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks', 'description': 'Began study in IOP but was nonengaged at week 2. Randomized to Patient Choice.\n\nMotivational Interviewing: 2 sessions at week 2 presenting treatment choices to participants.\n\nTelephone counseling: one telephone counseling session per week for 10 weeks.\n\nCognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.\n\nMedication Management: Prescription for Naltrexone'}, {'id': 'OG006', 'title': 'No Further Intervention', 'description': 'Not engaged at week 2 and still not engaged at week 8.\n\nRandomized to receive no further study intervention.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.56', 'spread': '23.55', 'groupId': 'OG001'}, {'value': '7.01', 'spread': '23.15', 'groupId': 'OG002'}, {'value': '20.98', 'spread': '37.77', 'groupId': 'OG003'}, {'value': '8.98', 'spread': '24.84', 'groupId': 'OG004'}, {'value': '5.75', 'spread': '11.73', 'groupId': 'OG005'}, {'value': '13.93', 'spread': '30.18', 'groupId': 'OG006'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 4 (weeks 13 - 16 post baseline)', 'description': 'Percent days heavy drinking at follow up, from Time Line Follow Back\n\n\\*heavy drinking is defined as five or more drinks per drinking day for men, four or more for women', 'unitOfMeasure': 'percentage of days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed represents the number that were available to provide research data. Those participants who were engaged and remained engaged in treatment were not included in these analyses.'}, {'type': 'PRIMARY', 'title': 'Percent Days Heavy Drinking', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}, {'value': '33', 'groupId': 'OG004'}, {'value': '23', 'groupId': 'OG005'}, {'value': '30', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Engaged', 'description': 'Engaged at week 2 and remained engaged throughout the 8 weeks of study participation.\n\nThis group did not receive any treatment intervention.'}, {'id': 'OG001', 'title': 'MI-PC Non-engaged at 2 Weeks', 'description': 'Participants start at IOP, but at 2 weeks are not engaged. Randomized to treatment choice:\n\nMotivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.\n\nTelephone counseling: one telephone counseling session per week for 10 weeks.\n\nCognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.\n\nMedication management: Prescription for naltrexone\n\nIntensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day.'}, {'id': 'OG002', 'title': 'MI-IOP Non-Engaged at 2 Weeks', 'description': 'Participants begin at IOP, but at 2 weeks are determined to no longer be engaged.\n\nRandomized to IOP\n\nMotivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.'}, {'id': 'OG003', 'title': 'MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks', 'description': 'Randomized to treatment choice, but remain attending treatment as usual then dropped out of treatment after randomization.\n\nMotivational Interviewing: 2 sessions at time of disengagement presenting treatment choices to participants.\n\nTelephone counseling: one telephone counseling session per week for 10 weeks.\n\nCognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.\n\nMedication Management: Prescription for Naltrexone'}, {'id': 'OG004', 'title': 'MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks', 'description': 'Initially engaged at IOP, but become nonengaged in weeks 3 - 8.\n\nMotivational Interviewing: 2 sessions at time of disengagement.\n\nReturn to IOP therapy 3 times weekly for three hours a day'}, {'id': 'OG005', 'title': 'MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks', 'description': 'Began study in IOP but was nonengaged at week 2. Randomized to Patient Choice.\n\nMotivational Interviewing: 2 sessions at week 2 presenting treatment choices to participants.\n\nTelephone counseling: one telephone counseling session per week for 10 weeks.\n\nCognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.\n\nMedication Management: Prescription for Naltrexone'}, {'id': 'OG006', 'title': 'No Further Intervention', 'description': 'Not engaged at week 2 and still not engaged at week 8.\n\nRandomized to receive no further study intervention.'}], 'classes': [{'categories': [{'measurements': [{'value': '13.49', 'spread': '27.37', 'groupId': 'OG001'}, {'value': '5.73', 'spread': '18.48', 'groupId': 'OG002'}, {'value': '20.09', 'spread': '33.40', 'groupId': 'OG003'}, {'value': '8.33', 'spread': '24.48', 'groupId': 'OG004'}, {'value': '5.43', 'spread': '15.19', 'groupId': 'OG005'}, {'value': '15.12', 'spread': '28.18', 'groupId': 'OG006'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 5 ( weeks 17 - 20 post baseline)', 'description': 'Percent days heavy drinking at follow up, from Time Line Follow Back\n\n\\* heavy drinking is defined as five or more drinks per drinking day for men, four or more for women', 'unitOfMeasure': 'percentage of days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed represents the number that were available to provide research data. Those participants who were engaged and remained engaged in treatment were not included in these analyses.'}, {'type': 'PRIMARY', 'title': 'Percent Days Heavy Drinking', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}, {'value': '33', 'groupId': 'OG004'}, {'value': '23', 'groupId': 'OG005'}, {'value': '30', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Engaged', 'description': 'Engaged at week 2 and remained engaged throughout the 8 weeks of study participation.\n\nThis group did not receive any treatment intervention.'}, {'id': 'OG001', 'title': 'MI-PC Non-engaged at 2 Weeks', 'description': 'Participants start at IOP, but at 2 weeks are not engaged. Randomized to treatment choice:\n\nMotivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.\n\nTelephone counseling: one telephone counseling session per week for 10 weeks.\n\nCognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.\n\nMedication management: Prescription for naltrexone\n\nIntensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day.'}, {'id': 'OG002', 'title': 'MI-IOP Non-Engaged at 2 Weeks', 'description': 'Participants begin at IOP, but at 2 weeks are determined to no longer be engaged.\n\nRandomized to IOP\n\nMotivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.'}, {'id': 'OG003', 'title': 'MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks', 'description': 'Randomized to treatment choice, but remain attending treatment as usual then dropped out of treatment after randomization.\n\nMotivational Interviewing: 2 sessions at time of disengagement presenting treatment choices to participants.\n\nTelephone counseling: one telephone counseling session per week for 10 weeks.\n\nCognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.\n\nMedication Management: Prescription for Naltrexone'}, {'id': 'OG004', 'title': 'MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks', 'description': 'Initially engaged at IOP, but become nonengaged in weeks 3 - 8.\n\nMotivational Interviewing: 2 sessions at time of disengagement.\n\nReturn to IOP therapy 3 times weekly for three hours a day'}, {'id': 'OG005', 'title': 'MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks', 'description': 'Began study in IOP but was nonengaged at week 2. Randomized to Patient Choice.\n\nMotivational Interviewing: 2 sessions at week 2 presenting treatment choices to participants.\n\nTelephone counseling: one telephone counseling session per week for 10 weeks.\n\nCognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.\n\nMedication Management: Prescription for Naltrexone'}, {'id': 'OG006', 'title': 'No Further Intervention', 'description': 'Not engaged at week 2 and still not engaged at week 8.\n\nRandomized to receive no further study intervention.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.30', 'spread': '23.91', 'groupId': 'OG001'}, {'value': '3.77', 'spread': '15.34', 'groupId': 'OG002'}, {'value': '18.3', 'spread': '34.52', 'groupId': 'OG003'}, {'value': '5.74', 'spread': '19.25', 'groupId': 'OG004'}, {'value': '7.61', 'spread': '21.73', 'groupId': 'OG005'}, {'value': '10.87', 'spread': '22.86', 'groupId': 'OG006'}]}]}], 'analyses': [{'pValue': '0.003', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.09', 'ciLowerLimit': '-1.80', 'ciUpperLimit': '-0.39', 'groupDescription': 'The statistical analyses used data from all follow up assessments.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.10', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.02', 'ciLowerLimit': '-1.10', 'ciUpperLimit': '1.14', 'groupDescription': 'The statistical analyses used data from all follow up assessments.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Month 6 (weeks 21 - 24 post baseline)', 'description': 'Percent days heavy drinking at follow up, from Time Line Follow Back\n\n\\*heavy drinking is defined as five or more drinks per drinking day for men, four or more for women', 'unitOfMeasure': 'percentage of days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed represents the number that were available to provide research data. Those participants who were engaged and remained engaged in treatment were not included in these analyses.'}, {'type': 'PRIMARY', 'title': 'Any Cocaine Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}, {'value': '33', 'groupId': 'OG004'}, {'value': '29', 'groupId': 'OG005'}, {'value': '35', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Engaged', 'description': 'Engaged at week 2 and remained engaged throughout the 8 weeks of study participation.\n\nThis group did not receive any treatment intervention.'}, {'id': 'OG001', 'title': 'MI-PC Non-engaged at 2 Weeks', 'description': 'Participants start at IOP, but at 2 weeks are not engaged. Randomized to treatment choice:\n\nMotivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.\n\nTelephone counseling: one telephone counseling session per week for 10 weeks.\n\nCognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.\n\nMedication management: Prescription for naltrexone\n\nIntensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day.'}, {'id': 'OG002', 'title': 'MI-IOP Non-Engaged at 2 Weeks', 'description': 'Participants begin at IOP, but at 2 weeks are determined to no longer be engaged.\n\nRandomized to IOP\n\nMotivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.'}, {'id': 'OG003', 'title': 'MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks', 'description': 'Randomized to treatment choice, but remain attending treatment as usual then dropped out of treatment after randomization.\n\nMotivational Interviewing: 2 sessions at time of disengagement presenting treatment choices to participants.\n\nTelephone counseling: one telephone counseling session per week for 10 weeks.\n\nCognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.\n\nMedication Management: Prescription for Naltrexone'}, {'id': 'OG004', 'title': 'MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks', 'description': 'Initially engaged at IOP, but become nonengaged in weeks 3 - 8.\n\nMotivational Interviewing: 2 sessions at time of disengagement.\n\nReturn to IOP therapy 3 times weekly for three hours a day'}, {'id': 'OG005', 'title': 'MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks', 'description': 'Began study in IOP but was nonengaged at week 2. Randomized to Patient Choice.\n\nMotivational Interviewing: 2 sessions at week 2 presenting treatment choices to participants.\n\nTelephone counseling: one telephone counseling session per week for 10 weeks.\n\nCognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.\n\nMedication Management: Prescription for Naltrexone'}, {'id': 'OG006', 'title': 'No Further Intervention', 'description': 'Not engaged at week 2 and still not engaged at week 8.\n\nRandomized to receive no further study intervention.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.45', 'spread': '0.50', 'groupId': 'OG001'}, {'value': '0.42', 'spread': '0.50', 'groupId': 'OG002'}, {'value': '0.31', 'spread': '0.47', 'groupId': 'OG003'}, {'value': '0.36', 'spread': '0.49', 'groupId': 'OG004'}, {'value': '0.66', 'spread': '0.48', 'groupId': 'OG005'}, {'value': '0.46', 'spread': '0.51', 'groupId': 'OG006'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 3 (weeks 9 - 12 post baseline)', 'description': 'Any cocaine using self report, binary measure of percent days cocaine use.', 'unitOfMeasure': 'proportion of participants', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed represents the number that were available to provide research data. Those participants who were engaged and remained engaged in treatment were not included in these analyses.'}, {'type': 'PRIMARY', 'title': 'Any Cocaine Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}, {'value': '30', 'groupId': 'OG004'}, {'value': '24', 'groupId': 'OG005'}, {'value': '31', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Engaged', 'description': 'Engaged at week 2 and remained engaged throughout the 8 weeks of study participation.\n\nThis group did not receive any treatment intervention.'}, {'id': 'OG001', 'title': 'MI-PC Non-engaged at 2 Weeks', 'description': 'Participants start at IOP, but at 2 weeks are not engaged. Randomized to treatment choice:\n\nMotivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.\n\nTelephone counseling: one telephone counseling session per week for 10 weeks.\n\nCognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.\n\nMedication management: Prescription for naltrexone\n\nIntensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day.'}, {'id': 'OG002', 'title': 'MI-IOP Non-Engaged at 2 Weeks', 'description': 'Participants begin at IOP, but at 2 weeks are determined to no longer be engaged.\n\nRandomized to IOP\n\nMotivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.'}, {'id': 'OG003', 'title': 'MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks', 'description': 'Randomized to treatment choice, but remain attending treatment as usual then dropped out of treatment after randomization.\n\nMotivational Interviewing: 2 sessions at time of disengagement presenting treatment choices to participants.\n\nTelephone counseling: one telephone counseling session per week for 10 weeks.\n\nCognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.\n\nMedication Management: Prescription for Naltrexone'}, {'id': 'OG004', 'title': 'MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks', 'description': 'Initially engaged at IOP, but become nonengaged in weeks 3 - 8.\n\nMotivational Interviewing: 2 sessions at time of disengagement.\n\nReturn to IOP therapy 3 times weekly for three hours a day'}, {'id': 'OG005', 'title': 'MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks', 'description': 'Began study in IOP but was nonengaged at week 2. Randomized to Patient Choice.\n\nMotivational Interviewing: 2 sessions at week 2 presenting treatment choices to participants.\n\nTelephone counseling: one telephone counseling session per week for 10 weeks.\n\nCognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.\n\nMedication Management: Prescription for Naltrexone'}, {'id': 'OG006', 'title': 'No Further Intervention', 'description': 'Not engaged at week 2 and still not engaged at week 8.\n\nRandomized to receive no further study intervention.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.43', 'spread': '0.50', 'groupId': 'OG001'}, {'value': '0.29', 'spread': '0.46', 'groupId': 'OG002'}, {'value': '0.39', 'spread': '0.50', 'groupId': 'OG003'}, {'value': '0.23', 'spread': '0.43', 'groupId': 'OG004'}, {'value': '0.63', 'spread': '0.49', 'groupId': 'OG005'}, {'value': '0.45', 'spread': '0.51', 'groupId': 'OG006'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 4 (weeks 13 - 16 post baseline)', 'description': 'Any cocaine using self report, binary measure of percent days cocaine use', 'unitOfMeasure': 'proportion of participants', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed represents the number that were available to provide research data. Those participants who were engaged and remained engaged in treatment were not included in these analyses.'}, {'type': 'PRIMARY', 'title': 'Any Cocaine Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}, {'value': '30', 'groupId': 'OG004'}, {'value': '24', 'groupId': 'OG005'}, {'value': '31', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Engaged', 'description': 'Engaged at week 2 and remained engaged throughout the 8 weeks of study participation.\n\nThis group did not receive any treatment intervention.'}, {'id': 'OG001', 'title': 'MI-PC Non-engaged at 2 Weeks', 'description': 'Participants start at IOP, but at 2 weeks are not engaged. Randomized to treatment choice:\n\nMotivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.\n\nTelephone counseling: one telephone counseling session per week for 10 weeks.\n\nCognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.\n\nMedication management: Prescription for naltrexone\n\nIntensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day.'}, {'id': 'OG002', 'title': 'MI-IOP Non-Engaged at 2 Weeks', 'description': 'Participants begin at IOP, but at 2 weeks are determined to no longer be engaged.\n\nRandomized to IOP\n\nMotivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.'}, {'id': 'OG003', 'title': 'MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks', 'description': 'Randomized to treatment choice, but remain attending treatment as usual then dropped out of treatment after randomization.\n\nMotivational Interviewing: 2 sessions at time of disengagement presenting treatment choices to participants.\n\nTelephone counseling: one telephone counseling session per week for 10 weeks.\n\nCognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.\n\nMedication Management: Prescription for Naltrexone'}, {'id': 'OG004', 'title': 'MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks', 'description': 'Initially engaged at IOP, but become nonengaged in weeks 3 - 8.\n\nMotivational Interviewing: 2 sessions at time of disengagement.\n\nReturn to IOP therapy 3 times weekly for three hours a day'}, {'id': 'OG005', 'title': 'MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks', 'description': 'Began study in IOP but was nonengaged at week 2. Randomized to Patient Choice.\n\nMotivational Interviewing: 2 sessions at week 2 presenting treatment choices to participants.\n\nTelephone counseling: one telephone counseling session per week for 10 weeks.\n\nCognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.\n\nMedication Management: Prescription for Naltrexone'}, {'id': 'OG006', 'title': 'No Further Intervention', 'description': 'Not engaged at week 2 and still not engaged at week 8.\n\nRandomized to receive no further study intervention.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.45', 'spread': '0.50', 'groupId': 'OG001'}, {'value': '0.35', 'spread': '0.48', 'groupId': 'OG002'}, {'value': '0.35', 'spread': '0.49', 'groupId': 'OG003'}, {'value': '0.23', 'spread': '0.43', 'groupId': 'OG004'}, {'value': '0.58', 'spread': '0.50', 'groupId': 'OG005'}, {'value': '0.42', 'spread': '0.50', 'groupId': 'OG006'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 5 (weeks 17 - 20 post baseline)', 'description': 'Any cocaine using self report, binary measure of percent days cocaine use', 'unitOfMeasure': 'proportion of participants', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed represents the number that were available to provide research data. Those participants who were engaged and remained engaged in treatment were not included in these analyses.'}, {'type': 'PRIMARY', 'title': 'Any Cocaine Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '65', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}, {'value': '30', 'groupId': 'OG004'}, {'value': '24', 'groupId': 'OG005'}, {'value': '31', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Engaged', 'description': 'Engaged at week 2 and remained engaged throughout the 8 weeks of study participation.\n\nThis group did not receive any treatment intervention.'}, {'id': 'OG001', 'title': 'MI-PC Non-engaged at 2 Weeks', 'description': 'Participants start at IOP, but at 2 weeks are not engaged. Randomized to treatment choice:\n\nMotivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.\n\nTelephone counseling: one telephone counseling session per week for 10 weeks.\n\nCognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.\n\nMedication management: Prescription for naltrexone\n\nIntensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day.'}, {'id': 'OG002', 'title': 'MI-IOP Non-Engaged at 2 Weeks', 'description': 'Participants begin at IOP, but at 2 weeks are determined to no longer be engaged.\n\nRandomized to IOP\n\nMotivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.'}, {'id': 'OG003', 'title': 'MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks', 'description': 'Randomized to treatment choice, but remain attending treatment as usual then dropped out of treatment after randomization.\n\nMotivational Interviewing: 2 sessions at time of disengagement presenting treatment choices to participants.\n\nTelephone counseling: one telephone counseling session per week for 10 weeks.\n\nCognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.\n\nMedication Management: Prescription for Naltrexone'}, {'id': 'OG004', 'title': 'MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks', 'description': 'Initially engaged at IOP, but become nonengaged in weeks 3 - 8.\n\nMotivational Interviewing: 2 sessions at time of disengagement.\n\nReturn to IOP therapy 3 times weekly for three hours a day'}, {'id': 'OG005', 'title': 'MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks', 'description': 'Began study in IOP but was nonengaged at week 2. Randomized to Patient Choice.\n\nMotivational Interviewing: 2 sessions at week 2 presenting treatment choices to participants.\n\nTelephone counseling: one telephone counseling session per week for 10 weeks.\n\nCognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.\n\nMedication Management: Prescription for Naltrexone'}, {'id': 'OG006', 'title': 'No Further Intervention', 'description': 'Not engaged at week 2 and still not engaged at week 8.\n\nRandomized to receive no further study intervention.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.35', 'spread': '0.48', 'groupId': 'OG001'}, {'value': '0.49', 'spread': '0.50', 'groupId': 'OG002'}, {'value': '0.35', 'spread': '0.49', 'groupId': 'OG003'}, {'value': '0.30', 'spread': '0.47', 'groupId': 'OG004'}, {'value': '0.54', 'spread': '0.51', 'groupId': 'OG005'}, {'value': '0.58', 'spread': '0.50', 'groupId': 'OG006'}]}]}], 'analyses': [{'pValue': '0.13', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.66', 'ciLowerLimit': '0.38', 'ciUpperLimit': '1.14', 'groupDescription': 'The statistical analyses used data from all follow up assessments.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.71', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.83', 'ciLowerLimit': '0.33', 'ciUpperLimit': '2.12', 'groupDescription': 'The statistical analyses used data from all follow up assessments.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.36', 'groupIds': ['OG005', 'OG006'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.48', 'ciLowerLimit': '0.64', 'ciUpperLimit': '3.40', 'groupDescription': 'The statistical analyses used data from all follow up assessments.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Month 6 (weeks 21 - 24 post baseline)', 'description': 'Any cocaine using self report, binary measure of percent days cocaine use', 'unitOfMeasure': 'proportion of participants', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed represents the number that were available to provide research data. Those participants who were engaged and remained engaged in treatment were not included in these analyses.'}, {'type': 'PRIMARY', 'title': 'Percent Days Cocaine Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}, {'value': '33', 'groupId': 'OG004'}, {'value': '30', 'groupId': 'OG005'}, {'value': '35', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Engaged', 'description': 'Engaged at week 2 and remained engaged throughout the 8 weeks of study participation.\n\nThis group did not receive any treatment intervention.'}, {'id': 'OG001', 'title': 'MI-PC Non-engaged at 2 Weeks', 'description': 'Participants start at IOP, but at 2 weeks are not engaged. Randomized to treatment choice:\n\nMotivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.\n\nTelephone counseling: one telephone counseling session per week for 10 weeks.\n\nCognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.\n\nMedication management: Prescription for naltrexone\n\nIntensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day.'}, {'id': 'OG002', 'title': 'MI-IOP Non-Engaged at 2 Weeks', 'description': 'Participants begin at IOP, but at 2 weeks are determined to no longer be engaged.\n\nRandomized to IOP\n\nMotivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.'}, {'id': 'OG003', 'title': 'MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks', 'description': 'Randomized to treatment choice, but remain attending treatment as usual then dropped out of treatment after randomization.\n\nMotivational Interviewing: 2 sessions at time of disengagement presenting treatment choices to participants.\n\nTelephone counseling: one telephone counseling session per week for 10 weeks.\n\nCognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.\n\nMedication Management: Prescription for Naltrexone'}, {'id': 'OG004', 'title': 'MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks', 'description': 'Initially engaged at IOP, but become nonengaged in weeks 3 - 8.\n\nMotivational Interviewing: 2 sessions at time of disengagement.\n\nReturn to IOP therapy 3 times weekly for three hours a day'}, {'id': 'OG005', 'title': 'MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks', 'description': 'Began study in IOP but was nonengaged at week 2. Randomized to Patient Choice.\n\nMotivational Interviewing: 2 sessions at week 2 presenting treatment choices to participants.\n\nTelephone counseling: one telephone counseling session per week for 10 weeks.\n\nCognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.\n\nMedication Management: Prescription for Naltrexone'}, {'id': 'OG006', 'title': 'No Further Intervention', 'description': 'Not engaged at week 2 and still not engaged at week 8.\n\nRandomized to receive no further study intervention.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.61', 'spread': '25.38', 'groupId': 'OG001'}, {'value': '9.35', 'spread': '20.19', 'groupId': 'OG002'}, {'value': '11.68', 'spread': '25.33', 'groupId': 'OG003'}, {'value': '3.90', 'spread': '7.54', 'groupId': 'OG004'}, {'value': '18.45', 'spread': '28.68', 'groupId': 'OG005'}, {'value': '12.35', 'spread': '23.39', 'groupId': 'OG006'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 3 (weeks 9 - 12 post baseline)', 'description': 'Percent days of any cocaine use, self reported', 'unitOfMeasure': 'percentage of days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed represents the number that were available to provide research data. Those participants who were engaged and remained engaged in treatment were not included in these analyses.'}, {'type': 'PRIMARY', 'title': 'Percent Days Cocaine Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}, {'value': '31', 'groupId': 'OG004'}, {'value': '25', 'groupId': 'OG005'}, {'value': '33', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Engaged', 'description': 'Engaged at week 2 and remained engaged throughout the 8 weeks of study participation.\n\nThis group did not receive any treatment intervention.'}, {'id': 'OG001', 'title': 'MI-PC Non-engaged at 2 Weeks', 'description': 'Participants start at IOP, but at 2 weeks are not engaged. Randomized to treatment choice:\n\nMotivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.\n\nTelephone counseling: one telephone counseling session per week for 10 weeks.\n\nCognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.\n\nMedication management: Prescription for naltrexone\n\nIntensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day.'}, {'id': 'OG002', 'title': 'MI-IOP Non-Engaged at 2 Weeks', 'description': 'Participants begin at IOP, but at 2 weeks are determined to no longer be engaged.\n\nRandomized to IOP\n\nMotivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.'}, {'id': 'OG003', 'title': 'MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks', 'description': 'Randomized to treatment choice, but remain attending treatment as usual then dropped out of treatment after randomization.\n\nMotivational Interviewing: 2 sessions at time of disengagement presenting treatment choices to participants.\n\nTelephone counseling: one telephone counseling session per week for 10 weeks.\n\nCognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.\n\nMedication Management: Prescription for Naltrexone'}, {'id': 'OG004', 'title': 'MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks', 'description': 'Initially engaged at IOP, but become nonengaged in weeks 3 - 8.\n\nMotivational Interviewing: 2 sessions at time of disengagement.\n\nReturn to IOP therapy 3 times weekly for three hours a day'}, {'id': 'OG005', 'title': 'MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks', 'description': 'Began study in IOP but was nonengaged at week 2. Randomized to Patient Choice.\n\nMotivational Interviewing: 2 sessions at week 2 presenting treatment choices to participants.\n\nTelephone counseling: one telephone counseling session per week for 10 weeks.\n\nCognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.\n\nMedication Management: Prescription for Naltrexone'}, {'id': 'OG006', 'title': 'No Further Intervention', 'description': 'Not engaged at week 2 and still not engaged at week 8.\n\nRandomized to receive no further study intervention.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.87', 'spread': '23.78', 'groupId': 'OG001'}, {'value': '12.60', 'spread': '28.40', 'groupId': 'OG002'}, {'value': '14.60', 'spread': '27.00', 'groupId': 'OG003'}, {'value': '4.26', 'spread': '17.99', 'groupId': 'OG004'}, {'value': '19.14', 'spread': '33.07', 'groupId': 'OG005'}, {'value': '15.26', 'spread': '28.28', 'groupId': 'OG006'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 5 (weeks 17 - 20 post baseline)', 'description': 'Percent days of any cocaine use, self reported', 'unitOfMeasure': 'percentage of days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed represents the number that were available to provide research data. Those participants who were engaged and remained engaged in treatment were not included in these analyses.'}, {'type': 'PRIMARY', 'title': 'Percent Days Cocaine Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}, {'value': '31', 'groupId': 'OG004'}, {'value': '25', 'groupId': 'OG005'}, {'value': '33', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Engaged', 'description': 'Engaged at week 2 and remained engaged throughout the 8 weeks of study participation.\n\nThis group did not receive any treatment intervention.'}, {'id': 'OG001', 'title': 'MI-PC Non-engaged at 2 Weeks', 'description': 'Participants start at IOP, but at 2 weeks are not engaged. Randomized to treatment choice:\n\nMotivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.\n\nTelephone counseling: one telephone counseling session per week for 10 weeks.\n\nCognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.\n\nMedication management: Prescription for naltrexone\n\nIntensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day.'}, {'id': 'OG002', 'title': 'MI-IOP Non-Engaged at 2 Weeks', 'description': 'Participants begin at IOP, but at 2 weeks are determined to no longer be engaged.\n\nRandomized to IOP\n\nMotivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.'}, {'id': 'OG003', 'title': 'MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks', 'description': 'Randomized to treatment choice, but remain attending treatment as usual then dropped out of treatment after randomization.\n\nMotivational Interviewing: 2 sessions at time of disengagement presenting treatment choices to participants.\n\nTelephone counseling: one telephone counseling session per week for 10 weeks.\n\nCognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.\n\nMedication Management: Prescription for Naltrexone'}, {'id': 'OG004', 'title': 'MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks', 'description': 'Initially engaged at IOP, but become nonengaged in weeks 3 - 8.\n\nMotivational Interviewing: 2 sessions at time of disengagement.\n\nReturn to IOP therapy 3 times weekly for three hours a day'}, {'id': 'OG005', 'title': 'MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks', 'description': 'Began study in IOP but was nonengaged at week 2. Randomized to Patient Choice.\n\nMotivational Interviewing: 2 sessions at week 2 presenting treatment choices to participants.\n\nTelephone counseling: one telephone counseling session per week for 10 weeks.\n\nCognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.\n\nMedication Management: Prescription for Naltrexone'}, {'id': 'OG006', 'title': 'No Further Intervention', 'description': 'Not engaged at week 2 and still not engaged at week 8.\n\nRandomized to receive no further study intervention.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.76', 'spread': '16.00', 'groupId': 'OG001'}, {'value': '9.50', 'spread': '24.27', 'groupId': 'OG002'}, {'value': '10.09', 'spread': '22.40', 'groupId': 'OG003'}, {'value': '4.95', 'spread': '13.19', 'groupId': 'OG004'}, {'value': '15.57', 'spread': '28.02', 'groupId': 'OG005'}, {'value': '13.35', 'spread': '26.10', 'groupId': 'OG006'}]}]}], 'analyses': [{'pValue': '0.75', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.13', 'ciLowerLimit': '-0.94', 'ciUpperLimit': '0.60', 'groupDescription': 'The statistical analyses used data from all follow up assessments.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.16', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.84', 'ciLowerLimit': '-1.98', 'ciUpperLimit': '0.30', 'groupDescription': 'The statistical analyses used data from all follow up assessments.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.42', 'groupIds': ['OG005', 'OG006'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.60', 'ciLowerLimit': '-0.85', 'ciUpperLimit': '2.04', 'groupDescription': 'The statistical analyses used data from all follow up assessments.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Month 6 (weeks 21 - 24 post baseline)', 'description': 'Percent days of any cocaine use, self reported', 'unitOfMeasure': 'percentage of days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed represents the number that were available to provide research data. Those participants who were engaged and remained engaged in treatment were not included in these analyses.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Engaged', 'description': 'Engaged at week 2 and remained engaged throughout the 8 weeks of study participation.\n\nThis group did not receive any treatment intervention.'}, {'id': 'FG001', 'title': 'MI-PC Non-engaged at 2 Weeks', 'description': 'Participants start at IOP, but at 2 weeks are not engaged. Randomized to treatment choice:\n\nMotivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.\n\nTelephone counseling: one telephone counseling session per week for 10 weeks.\n\nCognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.\n\nMedication management: Prescription for naltrexone\n\nIntensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day.'}, {'id': 'FG002', 'title': 'MI-IOP Non-Engaged at 2 Weeks', 'description': 'Participants begin at IOP, but at 2 weeks are determined to no longer be engaged.\n\nRandomized to IOP\n\nMotivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.'}, {'id': 'FG003', 'title': 'MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks', 'description': 'Randomized to treatment choice, but remain attending treatment as usual then dropped out of treatment after randomization.\n\nMotivational Interviewing: 2 sessions at time of disengagement presenting treatment choices to participants.\n\nTelephone counseling: one telephone counseling session per week for 10 weeks.\n\nCognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.\n\nMedication Management: Prescription for Naltrexone'}, {'id': 'FG004', 'title': 'MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks', 'description': 'Initially engaged at IOP, but become nonengaged in weeks 3 - 8.\n\nMotivational Interviewing: 2 sessions at time of disengagement.\n\nReturn to IOP therapy 3 times weekly for three hours a day'}, {'id': 'FG005', 'title': 'MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks', 'description': 'Began study in IOP but was nonengaged at week 2. Randomized to Patient Choice.\n\nMotivational Interviewing: 2 sessions at week 2 presenting treatment choices to participants.\n\nTelephone counseling: one telephone counseling session per week for 10 weeks.\n\nCognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.\n\nMedication Management: Prescription for Naltrexone'}, {'id': 'FG006', 'title': 'No Further Intervention', 'description': 'Not engaged at week 2 and still not engaged at week 8.\n\nRandomized to receive no further study intervention.'}], 'periods': [{'title': '2 Week Randomization', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '311'}, {'groupId': 'FG001', 'numSubjects': '93'}, {'groupId': 'FG002', 'numSubjects': '96'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '311'}, {'groupId': 'FG001', 'numSubjects': '93'}, {'groupId': 'FG002', 'numSubjects': '96'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}]}, {'title': '8 Week Randomization', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '227'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '41'}, {'groupId': 'FG004', 'numSubjects': '43'}, {'groupId': 'FG005', 'numSubjects': '48'}, {'groupId': 'FG006', 'numSubjects': '54'}]}, {'type': '12 Week Follow up', 'achievements': [{'comment': "These participants were'nt included in analyses as they didn't meet criteria for study intervention.", 'groupId': 'FG000', 'numSubjects': '217'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '34'}, {'groupId': 'FG004', 'numSubjects': '38'}, {'groupId': 'FG005', 'numSubjects': '36'}, {'groupId': 'FG006', 'numSubjects': '41'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': "These participants were'nt included in analyses as they didn't meet criteria for study intervention.", 'groupId': 'FG000', 'numSubjects': '201'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '30'}, {'groupId': 'FG004', 'numSubjects': '34'}, {'groupId': 'FG005', 'numSubjects': '31'}, {'groupId': 'FG006', 'numSubjects': '36'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '11'}, {'groupId': 'FG004', 'numSubjects': '9'}, {'groupId': 'FG005', 'numSubjects': '17'}, {'groupId': 'FG006', 'numSubjects': '18'}]}]}], 'preAssignmentDetails': 'All participants were enrolled when they entered IOP treatment. We collected baseline measures and monitored their treatment attendance. At 2 weeks, we determined whether they were engaged or nonengaged and randomized all participants at that time. Only those that were nonengaged at week 2 and still nonengaged at week 8 were rerandomized at week 8.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '227', 'groupId': 'BG000'}, {'value': '93', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}, {'value': '41', 'groupId': 'BG003'}, {'value': '43', 'groupId': 'BG004'}, {'value': '500', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'Engaged', 'description': 'Participants began treatment in IOP, consistently remained engaged in IOP throughout the study time period. This group did not reach the threshold of needing study intervention.'}, {'id': 'BG001', 'title': 'MI-PC Non-Engaged', 'description': 'Participants began treatment in IOP but were not engaged at week 2. Randomized to receive patient choice.\n\nMotivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.\n\nTelephone counseling: one telephone counseling session per week for 10 weeks.\n\nCognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.\n\nmedication management: Prescription for naltrexone\n\nIntensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day.'}, {'id': 'BG002', 'title': 'MI-IOP Non-Engaged', 'description': 'Participants began treatment in IOP but were not engaged at week 2. Randomized back to IOP.\n\nMotivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.'}, {'id': 'BG003', 'title': 'MI-PC Engaged at 2 Weeks, Non-engaged Before 8 Weeks', 'description': 'Participants began treatment in IOP and were engaged at week 2. However, they dropped out of treatment between weeks 3 - 8. Randomized to Patient Choice.\n\nMotivational Interviewing: 2 sessions at week 2.\n\nTelephone counseling: one telephone counseling session per week for 10 weeks.\n\nCognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.\n\nmedication management: Prescription for naltrexone\n\nIntensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day.'}, {'id': 'BG004', 'title': 'MI-IOP Engaged at 2 Weeks, Non-engaged Before 8 Weeks', 'description': 'Participants began treatment in IOP and were engaged at week 2. However, they dropped out of treatment between weeks 3 - 8. Randomized back to IOP.\n\nMotivational Interviewing: 2 sessions at week 2.'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '224', 'groupId': 'BG000'}, {'value': '91', 'groupId': 'BG001'}, {'value': '94', 'groupId': 'BG002'}, {'value': '41', 'groupId': 'BG003'}, {'value': '43', 'groupId': 'BG004'}, {'value': '493', 'groupId': 'BG005'}]}, {'title': '>=65 years', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '7', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '49.4', 'spread': '8.35', 'groupId': 'BG000'}, {'value': '48.02', 'spread': '9.84', 'groupId': 'BG001'}, {'value': '47.7', 'spread': '9.38', 'groupId': 'BG002'}, {'value': '47.8', 'spread': '9.42', 'groupId': 'BG003'}, {'value': '48.5', 'spread': '9.64', 'groupId': 'BG004'}, {'value': '48.29', 'spread': '8.92', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}, {'value': '95', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '191', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '75', 'groupId': 'BG002'}, {'value': '33', 'groupId': 'BG003'}, {'value': '34', 'groupId': 'BG004'}, {'value': '405', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '227', 'groupId': 'BG000'}, {'value': '93', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}, {'value': '41', 'groupId': 'BG003'}, {'value': '43', 'groupId': 'BG004'}, {'value': '500', 'groupId': 'BG005'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 500}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-01', 'studyFirstSubmitDate': '2009-12-14', 'resultsFirstSubmitDate': '2017-03-28', 'studyFirstSubmitQcDate': '2009-12-14', 'lastUpdatePostDateStruct': {'date': '2017-09-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-03-28', 'studyFirstPostDateStruct': {'date': '2009-12-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-05-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Treatment Engagement', 'timeFrame': 'weeks 3 - 12', 'description': 'Number of treatment sessions attended'}, {'measure': 'Treatment Engagement for Participants Engaged at 2 Weeks, But Disengage Before 8 Weeks', 'timeFrame': 'weeks 9 - 12', 'description': 'Number of treatment sessions attended'}, {'measure': 'Treatment Engagement of Those Non-engaged at 2 Weeks and at 8 Weeks', 'timeFrame': 'weeks 9 - 12', 'description': 'Number of treatment sessions attended'}, {'measure': 'Any Drinking Days in Previous Month', 'timeFrame': 'Month 2 (weeks 5 - 8 post baseline)', 'description': 'Days of any drinking in previous month, as reported on Time Line Follow Back. This is a dichotomous measure, so the means that are reported are the percentage of people who have had any days of drinking during the follow up period specified. In other words, 0.57 indicates that 57% of the sample drank in the follow up period.'}, {'measure': 'Any Drinking Days in Previous Month', 'timeFrame': 'Month 3 (weeks 9 - 12 post baseline)', 'description': 'Any drinking days during previous month, as reported on Time Line Follow Back. This is a dichotomous measure, so the means that are reported are the percentage of people who have had any days of drinking during the follow up period specified. In other words, 0.57 indicates that 57% of the sample drank in the follow up period.'}, {'measure': 'Any Drinking', 'timeFrame': 'Month 4 (weeks 13 - 15 post baseline)', 'description': 'Any drinking at follow up, as reported on Time Line Follow Back. This is a dichotomous measure, so the means that are reported are the percentage of people who have had any days of drinking during the follow up period specified. In other words, 0.57 indicates that 57% of the sample drank in the follow up period.'}, {'measure': 'Any Drinking', 'timeFrame': 'Month 5 (weeks 16 - 20 post baseline)', 'description': 'Any drinking at follow up, as reported on Time Line Follow Back, This is a dichotomous measure, so the means that are reported are the percentage of people who have had any days of drinking during the follow up period specified. In other words, 0.57 indicates that 57% of the sample drank in the follow up period.'}, {'measure': 'Any Drinking', 'timeFrame': 'Month 6 (weeks 21 - 24 post baseline)', 'description': 'Any drinking at follow up, as reported on Time Line Follow Back. This is a dichotomous measure, so the means that are reported are the percentage of people who have had any days of drinking during the follow up period specified. In other words, 0.57 indicates that 57% of the sample drank in the follow up period.'}, {'measure': 'Percent Days Drinking', 'timeFrame': 'Month 2 (weeks 5 - 8 post baseline)', 'description': 'Percent days of any drinking at follow up, from Time Line Follow Back'}, {'measure': 'Percent Days Drinking', 'timeFrame': 'Month 3 (weeks 9 - 12 post baseline)', 'description': 'Percent days of any drinking at follow up, from Time Line Follow Back'}, {'measure': 'Percent Days Drinking', 'timeFrame': 'Month 4 (weeks 13 - 16 post baseline)', 'description': 'Percent days of any drinking at follow up, from Time Line Follow Back'}, {'measure': 'Percent Days Drinking', 'timeFrame': 'Month 5 (weeks 17 - 20 post baseline)', 'description': 'Percent days of any drinking at follow up, fromTime Line Follow Back'}, {'measure': 'Percent Days Drinking', 'timeFrame': 'Month 6 (weeks 21 - 24)', 'description': 'Percent days of any drinking at follow up, from Time Line Follow Back'}, {'measure': 'Any Heavy Drinking Days', 'timeFrame': 'Month 2 (weeks 5 - 8 post baseline)', 'description': 'days of five or more drinks per drinking day for men, four or more drinks per drinking day for women, at follow up, from Time Line Follow Back. This is a dichotomous measure, so the means that are reported are the percentage of people who have had any days of heavy drinking during the follow up period specified. In other words, 0.57 indicates that 57% of the sample engaged in heavy drinking in the follow up period.'}, {'measure': 'Any Heavy Drinking Days', 'timeFrame': 'Month 3 (weeks 9 - 12 post baseline)', 'description': 'five or more drinks per drinking day for men, four or more drinks per drinking day for women, at follow up, from Time Line Follow Back. This is a dichotomous measure, so the means that are reported are the percentage of people who have had any days of heavy drinking during the follow up period specified. In other words, 0.57 indicates that 57% of the sample engaged in heavy drinking in the follow up period.'}, {'measure': 'Any Heavy Drinking Days', 'timeFrame': 'Month 4 (weeks 13 - 16 post baseline)', 'description': 'five or more drinks per drinking day for men, four or more drinks per drinking day for women at follow up, from Time Line Follow Back. This is a dichotomous measure, so the means that are reported are the percentage of people who have had any days of heavy drinking during the follow up period specified. In other words, 0.57 indicates that 57% of the sample engaged in heavy drinking in the follow up period.'}, {'measure': 'Any Heavy Drinking Days', 'timeFrame': 'Month 5 (weeks 17 to 20 post baseline)', 'description': 'five or more drinks per day for men, four or more drinks per day for women, from Time Line Follow Back. This is a dichotomous measure, so the means that are reported are the percentage of people who have had any days of heavy drinking during the follow up period specified. In other words, 0.57 indicates that 57% of the sample engaged in heavy drinking in the follow up period.'}, {'measure': 'Any Heavy Drinking Days', 'timeFrame': 'Month 6 (weeks 21 - 24 post baseline)', 'description': 'five or more drinks per day for men, four or more drinks per day for women, from Time Line Follow Back. This is a dichotomous measure, so the means that are reported are the percentage of people who have had any days of heavy drinking during the follow up period specified. In other words, 0.57 indicates that 57% of the sample engaged in heavy drinking in the follow up period.'}, {'measure': 'Percent Days Heavy Drinking', 'timeFrame': 'Month 2 (weeks 5 - 8 post baseline)', 'description': 'Percent days heavy drinking at follow up, from Time Line Follow Back\n\n\\*heavy drinking is defined as five or more drinks per day for men, four or more for women'}, {'measure': 'Percent Days Heavy Drinking', 'timeFrame': 'Month 3 (weeks 9 - 12 post baseline)', 'description': 'Percent days heavy drinking at follow up, from Time Line Follow Back\n\n\\* heavy drinking is defined as five or more drinks per day for men, four or more for women.'}, {'measure': 'Percent Days Heavy Drinking', 'timeFrame': 'Month 4 (weeks 13 - 16 post baseline)', 'description': 'Percent days heavy drinking at follow up, from Time Line Follow Back\n\n\\*heavy drinking is defined as five or more drinks per drinking day for men, four or more for women'}, {'measure': 'Percent Days Heavy Drinking', 'timeFrame': 'Month 5 ( weeks 17 - 20 post baseline)', 'description': 'Percent days heavy drinking at follow up, from Time Line Follow Back\n\n\\* heavy drinking is defined as five or more drinks per drinking day for men, four or more for women'}, {'measure': 'Percent Days Heavy Drinking', 'timeFrame': 'Month 6 (weeks 21 - 24 post baseline)', 'description': 'Percent days heavy drinking at follow up, from Time Line Follow Back\n\n\\*heavy drinking is defined as five or more drinks per drinking day for men, four or more for women'}, {'measure': 'Any Cocaine Use', 'timeFrame': 'Month 3 (weeks 9 - 12 post baseline)', 'description': 'Any cocaine using self report, binary measure of percent days cocaine use.'}, {'measure': 'Any Cocaine Use', 'timeFrame': 'Month 4 (weeks 13 - 16 post baseline)', 'description': 'Any cocaine using self report, binary measure of percent days cocaine use'}, {'measure': 'Any Cocaine Use', 'timeFrame': 'Month 5 (weeks 17 - 20 post baseline)', 'description': 'Any cocaine using self report, binary measure of percent days cocaine use'}, {'measure': 'Any Cocaine Use', 'timeFrame': 'Month 6 (weeks 21 - 24 post baseline)', 'description': 'Any cocaine using self report, binary measure of percent days cocaine use'}, {'measure': 'Percent Days Cocaine Use', 'timeFrame': 'Month 3 (weeks 9 - 12 post baseline)', 'description': 'Percent days of any cocaine use, self reported'}, {'measure': 'Percent Days Cocaine Use', 'timeFrame': 'Month 5 (weeks 17 - 20 post baseline)', 'description': 'Percent days of any cocaine use, self reported'}, {'measure': 'Percent Days Cocaine Use', 'timeFrame': 'Month 6 (weeks 21 - 24 post baseline)', 'description': 'Percent days of any cocaine use, self reported'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Substance Use Disorders']}, 'descriptionModule': {'briefSummary': '1. Primary objective #1: Determine the relative effectiveness of MI-IOP and MI-PC in the full study sample with regard to treatment engagement over weeks 1-12 and cocaine/alcohol use over weeks 1-24.\n\n * Hypothesis 1: An intervention that explores several possible treatment options with the patient and provides the chosen option (e.g., MI-PC) will produce higher rates of treatment engagement than an intervention focused on engagement in IOP only (e.g., MI-IOP).\n * Hypothesis 2: An intervention that explores several possible treatment options with the patient and provides the chosen option (e.g., MI-PC) will produce better cocaine/alcohol use outcomes than an intervention focused on engagement in IOP only (MI-IOP).\n * Secondary analysis 1: Among the Non-engaged patients, determine rates of selection of each of the three options in MI-PC, retention rates within each option, and cocaine/alcohol use outcomes in each option.\n * Secondary analysis 2: Among the Engaged patients, determine rates of selection of each of the three options in MI-PC, retention rates within each option, and cocaine/alcohol use outcomes in each option.\n2. Primary objective #2: Determine whether the relative effectiveness of MI-IOP and MI-PC varies as a function of engagement group, with regard to treatment engagement over weeks 1-12 and cocaine/alcohol use outcomes over weeks 1-24.\n\n * Hypothesis 1: The predicted main effect on retention favoring MI-PC over MI-IOP will be significantly larger among patients in the Non-engaged group than among those in the Engaged group.\n * Hypothesis 2: The predicted main effect on cocaine/alcohol use outcomes favoring MI-PC over MI-IOP will be significantly larger among patients in the Non-engaged group than among those in the Engaged group.', 'detailedDescription': '3\\. Secondary objective #1: Examine outcomes on three secondary measures: percent days abstinent from all substances, negative consequences of drug use, and HIV high risk behaviors.\n\n* Hypothesis 1: Outcomes on the secondary measures will be better in MI-PC than in MI-IOP.\n\n 4\\. Secondary objective #2: Test hypotheses concerning potential mediators of the predicted main effect favoring MI-PC over MI-IOP.\n* Hypothesis 1: The predicted advantage of MI-PC over MI-IOP will be mediated by greater increases in motivation, self-efficacy, commitment to abstinence, and self-help involvement in MI-PC.\n\n 5\\. Secondary objective #3: Test hypotheses concerning effect of additional MI intervention after initial non-engagement persists through 12 weeks.\n* Hypothesis 1: A second telephone MI intervention will produce higher rates of subsequent engagement and less cocaine use than no further MI.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. meet DSM-IV criteria for lifetime cocaine or alcohol dependence and have used cocaine or alcohol in the prior 6 months;\n2. be \\> 18 years of age;\n3. be judged clinically appropriate for IOP (e.g., no current psychotic disorder or evidence of severe dementia, and no acute medical problem requiring inpatient treatment;\n4. have no regular IV heroin use during the past year;\n5. have access to a telephone;\n6. be willing to be randomized and participate in research; and\n7. no current participation in methadone or other forms of DA treatment, other than IOP. Finally, because of study follow-up requirements, subjects will\n8. be required to be metropolitan area residents, and\n9. be able to provide the name, verified telephone number, and address of at least two contacts who can provide locator information on the patient during follow-up. We will include patients with dependence on other substances, provided that they are cocaine dependent and meet other inclusion criteria.\n\nExclusion Criteria:\n\n1. have a current psychotic disorder (as assessed with the psychotic screen from the MINI) or evidence of dementia severe enough to prevent participation in outpatient treatment;\n2. have acute medical problem requiring immediate inpatient treatment; or\n3. are currently participating in methadone or other forms of DA treatment, other than IOP.'}, 'identificationModule': {'nctId': 'NCT01032135', 'briefTitle': 'Adaptive Treatment for Alcohol and Cocaine Dependence', 'nctIdAliases': ['NCT02689674'], 'organization': {'class': 'OTHER', 'fullName': 'University of Pennsylvania'}, 'officialTitle': 'Adaptive Treatment for Alcohol and Cocaine Dependence', 'orgStudyIdInfo': {'id': '807092'}, 'secondaryIdInfos': [{'id': 'IND: 101,486'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1-MI-IOP Engaged', 'description': 'Randomized to treatment as usual, and they attend regularly but dropped out of treatment after randomization.', 'interventionNames': ['Behavioral: Motivational Interviewing']}, {'type': 'EXPERIMENTAL', 'label': '2-MI-IOP Non-Engaged', 'description': 'Randomized to treatment as usual, and do not attend.', 'interventionNames': ['Behavioral: Motivational Interviewing', 'Behavioral: Telephone counseling', 'Behavioral: Cognitive Behavioral Therapy (CBT) Counseling', 'Drug: medication management', 'Behavioral: Intensive OutPatient Therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': '3-MI-PC Engaged', 'description': 'Randomized to treatment choice, but remain attending treatment as usual then dropped out of treatment after randomization.', 'interventionNames': ['Behavioral: Motivational Interviewing', 'Behavioral: Telephone counseling', 'Behavioral: Cognitive Behavioral Therapy (CBT) Counseling']}, {'type': 'EXPERIMENTAL', 'label': '4-MI-PC Non-engaged', 'description': 'Randomized to treatment choice, and do not attend treatment as usual, so the choice option is used.', 'interventionNames': ['Behavioral: Motivational Interviewing', 'Behavioral: Telephone counseling', 'Behavioral: Cognitive Behavioral Therapy (CBT) Counseling', 'Drug: medication management', 'Behavioral: Intensive OutPatient Therapy']}], 'interventions': [{'name': 'Motivational Interviewing', 'type': 'BEHAVIORAL', 'otherNames': ['MI'], 'description': '2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.', 'armGroupLabels': ['1-MI-IOP Engaged', '2-MI-IOP Non-Engaged', '3-MI-PC Engaged', '4-MI-PC Non-engaged']}, {'name': 'Telephone counseling', 'type': 'BEHAVIORAL', 'otherNames': ['Telephone based stepped care.'], 'description': 'one telephone counseling session per week for 10 weeks.', 'armGroupLabels': ['2-MI-IOP Non-Engaged', '3-MI-PC Engaged', '4-MI-PC Non-engaged']}, {'name': 'Cognitive Behavioral Therapy (CBT) Counseling', 'type': 'BEHAVIORAL', 'otherNames': ['CBT'], 'description': 'One CBT session per week, for 10 weeks.', 'armGroupLabels': ['2-MI-IOP Non-Engaged', '3-MI-PC Engaged', '4-MI-PC Non-engaged']}, {'name': 'medication management', 'type': 'DRUG', 'otherNames': ['MM'], 'description': 'Prescription for naltrexone', 'armGroupLabels': ['2-MI-IOP Non-Engaged', '4-MI-PC Non-engaged']}, {'name': 'Intensive OutPatient Therapy', 'type': 'BEHAVIORAL', 'otherNames': ['IOP'], 'description': 'Return to IOP, group therapy 3 times weekly for about three hours a day.', 'armGroupLabels': ['2-MI-IOP Non-Engaged', '4-MI-PC Non-engaged']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Presbyterian Medical Center', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'VAMC', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '19123', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'NorthEast Treatment Center', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'James R. McKay, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pennsylvania'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pennsylvania', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}