Ignite Creation Date:
2025-12-24 @ 7:48 PM
Ignite Modification Date:
2025-12-25 @ 5:25 PM
Study NCT ID:
NCT00634803
Status:
COMPLETED
Last Update Posted:
2021-08-02
First Post:
2008-01-02
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Clinical Trial of Integrated Treatment for Pain and Opioid Dependence
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009293', 'term': 'Opioid-Related Disorders'}, {'id': 'D059350', 'term': 'Chronic Pain'}], 'ancestors': [{'id': 'D000079524', 'term': 'Narcotic-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002047', 'term': 'Buprenorphine'}, {'id': 'D020399', 'term': 'Practice Management'}], 'ancestors': [{'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010616', 'term': 'Phenanthrenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D011364', 'term': 'Professional Practice'}, {'id': 'D009934', 'term': 'Organization and Administration'}, {'id': 'D006298', 'term': 'Health Services Administration'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'richard.schottenfeld@yale.edu', 'phone': '203-974-7349', 'title': 'Richard S. Schottenfeld, M.D.', 'organization': 'Yale University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Up to the end of study (month 3)', 'eventGroups': [{'id': 'EG000', 'title': 'CBT for POD', 'description': 'Integrated cognitive behavioral therapy for chronic pain and opioid dependence\n\nCBT: Cognitive behavioral therapy\n\nBuprenorphine: buprenorphine/naloxone', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 0, 'seriousNumAtRisk': 30, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Educational Counseling for POD', 'description': 'Educational Counseling is a didactic, lecture-discussion format to supplement the information and advice provided by physicians in physician management (PM)\n\nBuprenorphine: buprenorphine/naloxone\n\nEducational Counseling: Didactic, lecture-discussion format to supplement information and advice provided by physicians', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 0, 'seriousNumAtRisk': 30, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Physician Management', 'description': 'PM is a relatively brief intervention that approximates the medically focused advice and brief counseling about medical issues that is typically provided by physicians to patients with chronic pain or other chronic medical conditions, such as diabetes or asthma.\n\nBuprenorphine: buprenorphine/naloxone\n\nPhysician Management: Brief physician counseling', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 0, 'seriousNumAtRisk': 30, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Pain Intensity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CBT for POD', 'description': 'Integrated cognitive behavioral therapy for chronic pain and opioid dependence\n\nCBT: Cognitive behavioral therapy\n\nBuprenorphine: buprenorphine/naloxone'}, {'id': 'OG001', 'title': 'Educational Counseling for POD', 'description': 'Educational Counseling is a didactic, lecture-discussion format to supplement the information and advice provided by physicians in physician management (PM)\n\nBuprenorphine: buprenorphine/naloxone\n\nEducational Counseling: Didactic, lecture-discussion format to supplement information and advice provided by physicians'}, {'id': 'OG002', 'title': 'Physician Management', 'description': 'PM is a relatively brief intervention that approximates the medically focused advice and brief counseling about medical issues that is typically provided by physicians to patients with chronic pain or other chronic medical conditions, such as diabetes or asthma.\n\nBuprenorphine: buprenorphine/naloxone\n\nPhysician Management: Brief physician counseling'}], 'classes': [{'title': 'Intake/Induction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5.43', 'spread': '1.34', 'groupId': 'OG000'}, {'value': '5.92', 'spread': '1.57', 'groupId': 'OG001'}, {'value': '5.28', 'spread': '1.34', 'groupId': 'OG002'}]}]}, {'title': 'Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.75', 'spread': '1.62', 'groupId': 'OG000'}, {'value': '5.02', 'spread': '1.45', 'groupId': 'OG001'}, {'value': '4.53', 'spread': '1.46', 'groupId': 'OG002'}]}]}, {'title': 'Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.79', 'spread': '1.50', 'groupId': 'OG000'}, {'value': '4.98', 'spread': '1.76', 'groupId': 'OG001'}, {'value': '4.72', 'spread': '1.81', 'groupId': 'OG002'}]}]}, {'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.41', 'spread': '1.67', 'groupId': 'OG000'}, {'value': '4.62', 'spread': '1.91', 'groupId': 'OG001'}, {'value': '4.84', 'spread': '1.91', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months', 'description': 'Pain intensity comprises the average of 4 items related to current pain and past-week average pain, pain at its worst, and pain at its least. Pain intensity is scored on 0-10 scale (average score ranges from 0-10), where higher scores indicate higher pain intensity.Originally labeled as Pain Reduction at 16 weeks- 3 months was the correct timeframe.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population is the intention to treat population and all observations across time periods were used in the analysis.'}, {'type': 'PRIMARY', 'title': 'Number of Opioid-negative Urine Toxicology Tests', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CBT for POD', 'description': 'Integrated cognitive behavioral therapy for chronic pain and opioid dependence\n\nCBT: Cognitive behavioral therapy\n\nBuprenorphine: buprenorphine/naloxone'}, {'id': 'OG001', 'title': 'Educational Counseling for POD', 'description': 'Educational Counseling is a didactic, lecture-discussion format to supplement the information and advice provided by physicians in physician management (PM)\n\nBuprenorphine: buprenorphine/naloxone\n\nEducational Counseling: Didactic, lecture-discussion format to supplement information and advice provided by physicians'}, {'id': 'OG002', 'title': 'Physician Management', 'description': 'PM is a relatively brief intervention that approximates the medically focused advice and brief counseling about medical issues that is typically provided by physicians to patients with chronic pain or other chronic medical conditions, such as diabetes or asthma.\n\nBuprenorphine: buprenorphine/naloxone\n\nPhysician Management: Brief physician counseling'}], 'classes': [{'title': 'Intake/Induction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.67', 'spread': '0.55', 'groupId': 'OG000'}, {'value': '0.67', 'spread': '0.48', 'groupId': 'OG001'}, {'value': '0.55', 'spread': '0.69', 'groupId': 'OG002'}]}]}, {'title': 'Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.67', 'spread': '1.42', 'groupId': 'OG000'}, {'value': '2.80', 'spread': '1.27', 'groupId': 'OG001'}, {'value': '2.48', 'spread': '1.70', 'groupId': 'OG002'}]}]}, {'title': 'Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.96', 'spread': '1.48', 'groupId': 'OG000'}, {'value': '3.30', 'spread': '1.14', 'groupId': 'OG001'}, {'value': '2.56', 'spread': '1.72', 'groupId': 'OG002'}]}]}, {'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.80', 'spread': '1.38', 'groupId': 'OG000'}, {'value': '3.25', 'spread': '1.22', 'groupId': 'OG001'}, {'value': '2.04', 'spread': '1.71', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 Months', 'description': 'Reduced illicit opioid use is defined as the number of documented opioid negative urine tests in each of the time periods.This measures the reduction in illicit opioid use - more opioid-negative tests means greater reductions in illicit opioid use. The highest possible score is 4- which would indicate 4 negative urine tests during the assessment period. Originally titled "Reduced illicit opioid use" and the timeframe was listed as 16 weeks.', 'unitOfMeasure': 'opioid negative urine tests', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population is the intention to treat population and all observations across time periods were used in the analysis. Participants may have contributed to this outcome but were lost to follow up during the time period and were not measured on pain related outcomes.'}, {'type': 'PRIMARY', 'title': 'Pain Interference', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CBT for POD', 'description': 'Integrated cognitive behavioral therapy for chronic pain and opioid dependence\n\nCBT: Cognitive behavioral therapy\n\nBuprenorphine: buprenorphine/naloxone'}, {'id': 'OG001', 'title': 'Educational Counseling for POD', 'description': 'Educational Counseling is a didactic, lecture-discussion format to supplement the information and advice provided by physicians in physician management (PM)\n\nBuprenorphine: buprenorphine/naloxone\n\nEducational Counseling: Didactic, lecture-discussion format to supplement information and advice provided by physicians'}, {'id': 'OG002', 'title': 'Physician Management', 'description': 'PM is a relatively brief intervention that approximates the medically focused advice and brief counseling about medical issues that is typically provided by physicians to patients with chronic pain or other chronic medical conditions, such as diabetes or asthma.\n\nBuprenorphine: buprenorphine/naloxone\n\nPhysician Management: Brief physician counseling'}], 'classes': [{'title': 'Intake/Induction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5.75', 'spread': '2.12', 'groupId': 'OG000'}, {'value': '5.48', 'spread': '2.23', 'groupId': 'OG001'}, {'value': '5.01', 'spread': '2.19', 'groupId': 'OG002'}]}]}, {'title': 'Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.15', 'spread': '2.09', 'groupId': 'OG000'}, {'value': '3.74', 'spread': '1.82', 'groupId': 'OG001'}, {'value': '3.32', 'spread': '2.12', 'groupId': 'OG002'}]}]}, {'title': 'Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.08', 'spread': '2.06', 'groupId': 'OG000'}, {'value': '3.61', 'spread': '1.97', 'groupId': 'OG001'}, {'value': '3.45', 'spread': '2.45', 'groupId': 'OG002'}]}]}, {'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.22', 'spread': '1.94', 'groupId': 'OG000'}, {'value': '3.23', 'spread': '2.27', 'groupId': 'OG001'}, {'value': '3.87', 'spread': '2.56', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 Months', 'description': 'Pain interference comprises the average of 7 items related to past-week pain-related interference in general activity, walking, work, mood, enjoyment of life, relations with others, and sleep. Each item is scored on a 0-10 scale (averaged 0-10), where higher scores indicate higher pain interference.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population is the intention to treat population and all observations across time periods were used in the analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'CBT for POD', 'description': 'Integrated cognitive behavioral therapy for chronic pain and opioid dependence\n\nCBT: Cognitive behavioral therapy\n\nBuprenorphine: buprenorphine/naloxone'}, {'id': 'FG001', 'title': 'Educational Counseling for POD', 'description': 'Educational Counseling is a didactic, lecture-discussion format to supplement the information and advice provided by physicians in physician management (PM)\n\nBuprenorphine: buprenorphine/naloxone\n\nEducational Counseling: Didactic, lecture-discussion format to supplement information and advice provided by physicians'}, {'id': 'FG002', 'title': 'Physician Management', 'description': 'PM is a relatively brief intervention that approximates the medically focused advice and brief counseling about medical issues that is typically provided by physicians to patients with chronic pain or other chronic medical conditions, such as diabetes or asthma.\n\nBuprenorphine: buprenorphine/naloxone\n\nPhysician Management: Brief physician counseling'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '30'}, {'groupId': 'FG002', 'numSubjects': '30'}]}, {'type': 'Month 1', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '29'}, {'groupId': 'FG002', 'numSubjects': '29'}]}, {'type': 'Month 2', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '26'}, {'groupId': 'FG002', 'numSubjects': '28'}]}, {'type': 'Month 3', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '23'}, {'groupId': 'FG002', 'numSubjects': '26'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '23'}, {'groupId': 'FG002', 'numSubjects': '23'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '7'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '90', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'CBT for POD', 'description': 'Integrated cognitive behavioral therapy for chronic pain and opioid dependence\n\nCBT: Cognitive behavioral therapy\n\nBuprenorphine: buprenorphine/naloxone'}, {'id': 'BG001', 'title': 'Educational Counseling for POD', 'description': 'Educational Counseling is a didactic, lecture-discussion format to supplement the information and advice provided by physicians in physician management (PM)\n\nBuprenorphine: buprenorphine/naloxone\n\nEducational Counseling: Didactic, lecture-discussion format to supplement information and advice provided by physicians'}, {'id': 'BG002', 'title': 'Physician Management', 'description': 'PM is a relatively brief intervention that approximates the medically focused advice and brief counseling about medical issues that is typically provided by physicians to patients with chronic pain or other chronic medical conditions, such as diabetes or asthma.\n\nBuprenorphine: buprenorphine/naloxone\n\nPhysician Management: Brief physician counseling'}, {'id': 'BG003', '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'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '90', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '35.3', 'spread': '9.4', 'groupId': 'BG000'}, {'value': '37.0', 'spread': '9.9', 'groupId': 'BG001'}, {'value': '35.3', 'spread': '10.00', 'groupId': 'BG002'}, {'value': '35.8', 'spread': '9.8', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '39', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '51', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '90', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-29', 'studyFirstSubmitDate': '2008-01-02', 'resultsFirstSubmitDate': '2020-08-16', 'studyFirstSubmitQcDate': '2008-03-06', 'lastUpdatePostDateStruct': {'date': '2021-08-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-08-16', 'studyFirstPostDateStruct': {'date': '2008-03-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain Intensity', 'timeFrame': '3 months', 'description': 'Pain intensity comprises the average of 4 items related to current pain and past-week average pain, pain at its worst, and pain at its least. Pain intensity is scored on 0-10 scale (average score ranges from 0-10), where higher scores indicate higher pain intensity.Originally labeled as Pain Reduction at 16 weeks- 3 months was the correct timeframe.'}, {'measure': 'Number of Opioid-negative Urine Toxicology Tests', 'timeFrame': '3 Months', 'description': 'Reduced illicit opioid use is defined as the number of documented opioid negative urine tests in each of the time periods.This measures the reduction in illicit opioid use - more opioid-negative tests means greater reductions in illicit opioid use. The highest possible score is 4- which would indicate 4 negative urine tests during the assessment period. Originally titled "Reduced illicit opioid use" and the timeframe was listed as 16 weeks.'}, {'measure': 'Pain Interference', 'timeFrame': '3 Months', 'description': 'Pain interference comprises the average of 7 items related to past-week pain-related interference in general activity, walking, work, mood, enjoyment of life, relations with others, and sleep. Each item is scored on a 0-10 scale (averaged 0-10), where higher scores indicate higher pain interference.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Opiate Dependence', 'Chronic Pain']}, 'referencesModule': {'references': [{'pmid': '27574837', 'type': 'DERIVED', 'citation': 'Barry DT, Cutter CJ, Beitel M, Kerns RD, Liong C, Schottenfeld RS. Psychiatric Disorders Among Patients Seeking Treatment for Co-Occurring Chronic Pain and Opioid Use Disorder. J Clin Psychiatry. 2016 Oct;77(10):1413-1419. doi: 10.4088/JCP.15m09963.'}]}, 'descriptionModule': {'briefSummary': 'This study is designed to develop an effective psychotherapy for chronic pain and opioid dependence.', 'detailedDescription': 'This study aims to develop a novel manualized intervention using tailored cognitive-behavioral treatment (CBT) and buprenorphine medication to effectively treat the co-occurring disorders of non-malignant pain and opioid dependence (POD).\n\nSpecific Aims:\n\n1. To conduct a pre-pilot phase with 16 patients with POD receiving buprenorphine maintenance treatment (BMT). In the pre-pilot phase, we will also explore the effects of different daily buprenorphine dosages on pain and opiate use.\n2. To conduct a pilot randomized, clinical trial to obtain data regarding the feasibility, acceptability and efficacy (compared to Physician Management(PM) only) of manual-guided CBT or Educational Counseling (EC) for patients with POD treated with BMT (N=75).\n\nThe secondary outcomes: Development of a Treatment Manual and Development and Modification of Initial Therapy Training and Process Rating Measures were process measures and not been to be included as measures associated with RCT. These outcomes were removed when the RCT results were entered. In addition, outcomes were renamed for clarification.\n\nAt results entry, the timeframe (16 weeks) was also corrected to account for the actual timeframe used for analysis in the study. The 16-week study period listed in the protocol included a 2-week buprenorphine induction period (before randomization) and up to a 2-week post-conclusion of the clinical trial continuation on buprenorphine and referral to continuing treatment. In prior studies with buprenorphine, the study team had observed an artificially high attrition during the last 2 weeks of the planned study protocol, when participants were attempting to transition to available clinical treatments outside of the study. Consequently, as per the original study protocol for this study, the plan was to analyze intake and induction data (as baseline data) and then the data from the first 12-weeks post-randomization.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age or older\n* prescription opioid addiction criteria\n* moderate to severe chronic pain\n* seeking or interested in buprenorphine maintenance\n* understand English\n\nExclusion Criteria:\n\n* methadone maintenance at a dose greater than 40 mg daily\n* current suicide or homicide risk\n* life-threatening or unstable medical problem\n* pregnancy'}, 'identificationModule': {'nctId': 'NCT00634803', 'acronym': 'POD', 'briefTitle': 'Clinical Trial of Integrated Treatment for Pain and Opioid Dependence', 'organization': {'class': 'OTHER', 'fullName': 'Yale University'}, 'officialTitle': 'Clinical Trial of Integrated Treatment for Pain and Opioid Dependence', 'orgStudyIdInfo': {'id': '0608001776'}, 'secondaryIdInfos': [{'id': '1R01DA024695-01A2', 'link': 'https://reporter.nih.gov/quickSearch/1R01DA024695-01A2', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CBT for POD', 'description': 'Integrated cognitive behavioral therapy for chronic pain and opioid dependence', 'interventionNames': ['Behavioral: CBT', 'Drug: Buprenorphine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Educational Counseling for POD', 'description': 'Educational Counseling is a didactic, lecture-discussion format to supplement the information and advice provided by physicians in physician management (PM)', 'interventionNames': ['Drug: Buprenorphine', 'Other: Educational Counseling']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Physician Management', 'description': 'PM is a relatively brief intervention that approximates the medically focused advice and brief counseling about medical issues that is typically provided by physicians to patients with chronic pain or other chronic medical conditions, such as diabetes or asthma.', 'interventionNames': ['Drug: Buprenorphine', 'Other: Physician Management']}], 'interventions': [{'name': 'CBT', 'type': 'BEHAVIORAL', 'description': 'Cognitive behavioral therapy', 'armGroupLabels': ['CBT for POD']}, {'name': 'Buprenorphine', 'type': 'DRUG', 'description': 'buprenorphine/naloxone', 'armGroupLabels': ['CBT for POD', 'Educational Counseling for POD', 'Physician Management']}, {'name': 'Educational Counseling', 'type': 'OTHER', 'description': 'Didactic, lecture-discussion format to supplement information and advice provided by physicians', 'armGroupLabels': ['Educational Counseling for POD']}, {'name': 'Physician Management', 'type': 'OTHER', 'description': 'Brief physician counseling', 'armGroupLabels': ['Physician Management']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06519', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Methadone Research Unit', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}], 'overallOfficials': [{'name': 'Richard S Schottenfeld, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yale University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yale University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}