Ignite Creation Date:
2025-12-25 @ 1:18 AM
Ignite Modification Date:
2025-12-25 @ 11:26 PM
Study NCT ID:
NCT01442493
Status:
COMPLETED
Last Update Posted:
2017-12-29
First Post:
2011-09-07
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Reengineering Methadone Treatment Study of Patient-centered Methadone Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009293', 'term': 'Opioid-Related Disorders'}], 'ancestors': [{'id': 'D000079524', 'term': 'Narcotic-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'rschwartz@friendsresearch.org', 'phone': '410-837-3977', 'title': 'Robert Schwartz, M.D.', 'phoneExt': '276', 'organization': 'Friends Research Institute'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '1 year', 'description': 'All Serious Adverse Events were considered unrelated to study participation.', 'eventGroups': [{'id': 'EG000', 'title': 'Patient-Centered Methadone Treatment', 'description': "Patient-Centered Methadone Treatment alters the rules and staff roles in methadone treatment as usual in an attempt to increase treatment retention and improve patient outcomes.\n\nPatient-Centered Methadone Treatment: Unlike in treatment as usual, counseling will be encouraged but not required and counselors will be responsible for enforcing the clinic's rules. The rules will be enforced by the Clinical Director. Clinic rules will be modified such that involuntary discharge from treatment will be a rare event.", 'otherNumAtRisk': 146, 'deathsNumAtRisk': 146, 'otherNumAffected': 0, 'seriousNumAtRisk': 146, 'deathsNumAffected': 2, 'seriousNumAffected': 31}, {'id': 'EG001', 'title': 'Methadone Treatment as Usual', 'description': 'Methadone treatment provided as usual in the U.S.\n\nMethadone Treatment as usual: Counseling will be required and counselors will enforce the usual clinic rules. Involuntary discharge may occur for ongoing drug use or rule infractions as usually occurs in the clinic.', 'otherNumAtRisk': 149, 'deathsNumAtRisk': 149, 'otherNumAffected': 0, 'seriousNumAtRisk': 149, 'deathsNumAffected': 4, 'seriousNumAffected': 36}], 'seriousEvents': [{'term': 'Pain in Back, Hip, Jaw, Groin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Soft Tissue Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 149, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 149, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 149, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Knee Surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Seizures', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 149, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 149, 'numAffected': 4}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 149, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fibroids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Trauma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 149, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gout', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Lupus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 149, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Renal Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 149, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 149, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Uterine Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 149, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 149, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Chronic Obstructive Pulmonary Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 149, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Angina', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Tonsillectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 149, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'HIV', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 149, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Spontaneous abortion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 149, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pulmonary Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 149, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diabetes Mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 149, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Altered Mental Status', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 149, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 149, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Suicide attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 149, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Psychiatric Disorder Unspecified', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 149, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Congestive Heart Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 149, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Kidney stone', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 149, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Kidney Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 149, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Varices', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 149, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Infected catheter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 149, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 149, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 149, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Food poisoning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 149, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Poisoning of Unknown Origin and Type', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 149, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pulmonary Edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 149, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Opiate Positive Urine Tests', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Patient-Centered Methadone Treatment', 'description': "Patient-Centered Methadone Treatment alters the rules and staff roles in methadone treatment as usual in an attempt to increase treatment retention and improve patient outcomes.\n\nPatient-Centered Methadone Treatment: Unlike in treatment as usual, counseling will be encouraged but not required and counselors will be responsible for enforcing the clinic's rules. The rules will be enforced by the Clinical Director. Clinic rules will be modified such that involuntary discharge from treatment will be a rare event."}, {'id': 'OG001', 'title': 'Methadone Treatment as Usual', 'description': 'Methadone treatment provided as usual in the U.S.\n\nMethadone Treatment as usual: Counseling will be required and counselors will enforce the usual clinic rules. Involuntary discharge may occur for ongoing drug use or rule infractions as usually occurs in the clinic.'}], 'classes': [{'categories': [{'measurements': [{'value': '89', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.92', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12-months post-baseline', 'description': 'Number of participants with opiate positive urine tests', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Missing data were counted as positive'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Cocaine Positive Urine Tests', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Patient-Centered Methadone Treatment', 'description': "Patient-Centered Methadone Treatment alters the rules and staff roles in methadone treatment as usual in an attempt to increase treatment retention and improve patient outcomes.\n\nPatient-Centered Methadone Treatment: Unlike in treatment as usual, counseling will be encouraged but not required and counselors will be responsible for enforcing the clinic's rules. The rules will be enforced by the Clinical Director. Clinic rules will be modified such that involuntary discharge from treatment will be a rare event."}, {'id': 'OG001', 'title': 'Methadone Treatment as Usual', 'description': 'Methadone treatment provided as usual in the U.S.\n\nMethadone Treatment as usual: Counseling will be required and counselors will enforce the usual clinic rules. Involuntary discharge may occur for ongoing drug use or rule infractions as usually occurs in the clinic.'}], 'classes': [{'categories': [{'measurements': [{'value': '67', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.06', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12-months post-baseline', 'description': 'Cocaine positive urine drug test', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Missing data were considered positive'}, {'type': 'SECONDARY', 'title': 'Drug Use HIV Risk Behavior', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Patient-Centered Methadone Treatment', 'description': "Patient-Centered Methadone Treatment alters the rules and staff roles in methadone treatment as usual in an attempt to increase treatment retention and improve patient outcomes.\n\nPatient-Centered Methadone Treatment: Unlike in treatment as usual, counseling will be encouraged but not required and counselors will be responsible for enforcing the clinic's rules. The rules will be enforced by the Clinical Director. Clinic rules will be modified such that involuntary discharge from treatment will be a rare event."}, {'id': 'OG001', 'title': 'Methadone Treatment as Usual', 'description': 'Methadone treatment provided as usual in the U.S.\n\nMethadone Treatment as usual: Counseling will be required and counselors will enforce the usual clinic rules. Involuntary discharge may occur for ongoing drug use or rule infractions as usually occurs in the clinic.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.72', 'spread': '2.56', 'groupId': 'OG000'}, {'value': '1.36', 'spread': '3.63', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.08', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '12-months post-baseline', 'description': 'HIV Drug Use Risk Assessment Battery Score ranges from 0 to 22. A higher score is considered to be associated with higher risk.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Baseline values were used when 12 month data were missing.'}, {'type': 'SECONDARY', 'title': 'Criminal Behavior', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Patient-Centered Methadone Treatment', 'description': "Patient-Centered Methadone Treatment alters the rules and staff roles in methadone treatment as usual in an attempt to increase treatment retention and improve patient outcomes.\n\nPatient-Centered Methadone Treatment: Unlike in treatment as usual, counseling will be encouraged but not required and counselors will be responsible for enforcing the clinic's rules. The rules will be enforced by the Clinical Director. Clinic rules will be modified such that involuntary discharge from treatment will be a rare event."}, {'id': 'OG001', 'title': 'Methadone Treatment as Usual', 'description': 'Methadone treatment provided as usual in the U.S.\n\nMethadone Treatment as usual: Counseling will be required and counselors will enforce the usual clinic rules. Involuntary discharge may occur for ongoing drug use or rule infractions as usually occurs in the clinic.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.99', 'spread': '.75', 'groupId': 'OG000'}, {'value': '3.72', 'spread': '.93', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.54', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '12-months post-baseline', 'description': 'Days of criminal behavior', 'unitOfMeasure': 'Number of Days in the Past 30 days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Global Score on the World Health Organization Quality of Life Measure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Patient-Centered Methadone Treatment', 'description': "Patient-Centered Methadone Treatment alters the rules and staff roles in methadone treatment as usual in an attempt to increase treatment retention and improve patient outcomes.\n\nPatient-Centered Methadone Treatment: Unlike in treatment as usual, counseling will be encouraged but not required and counselors will be responsible for enforcing the clinic's rules. The rules will be enforced by the Clinical Director. Clinic rules will be modified such that involuntary discharge from treatment will be a rare event."}, {'id': 'OG001', 'title': 'Methadone Treatment as Usual', 'description': 'Methadone treatment provided as usual in the U.S.\n\nMethadone Treatment as usual: Counseling will be required and counselors will enforce the usual clinic rules. Involuntary discharge may occur for ongoing drug use or rule infractions as usually occurs in the clinic.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.70', 'spread': '0.91', 'groupId': 'OG000'}, {'value': '3.47', 'spread': '1.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.04', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '12-months post-baseline', 'description': 'Scale from 1 through 5. A higher score reflects a better quality of life.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Baseline values were used when 12 month data were missing'}, {'type': 'SECONDARY', 'title': 'Number of Participants Meeting DSM-IV Opiate Dependence Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Patient-Centered Methadone Treatment', 'description': "Patient-Centered Methadone Treatment alters the rules and staff roles in methadone treatment as usual in an attempt to increase treatment retention and improve patient outcomes.\n\nPatient-Centered Methadone Treatment: Unlike in treatment as usual, counseling will be encouraged but not required and counselors will be responsible for enforcing the clinic's rules. The rules will be enforced by the Clinical Director. Clinic rules will be modified such that involuntary discharge from treatment will be a rare event."}, {'id': 'OG001', 'title': 'Methadone Treatment as Usual', 'description': 'Methadone treatment provided as usual in the U.S.\n\nMethadone Treatment as usual: Counseling will be required and counselors will enforce the usual clinic rules. Involuntary discharge may occur for ongoing drug use or rule infractions as usually occurs in the clinic.'}], 'classes': [{'categories': [{'measurements': [{'value': '88', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.11', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12-months post-baseline', 'description': 'Diagnostic and Statistical Manual (DSM)-IV criteria for opiate dependence', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Baseline values were used when 12 month data were missing'}, {'type': 'SECONDARY', 'title': 'Number of Participants Meeting DSM-IV Cocaine Dependence Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Patient-Centered Methadone Treatment', 'description': "Patient-Centered Methadone Treatment alters the rules and staff roles in methadone treatment as usual in an attempt to increase treatment retention and improve patient outcomes.\n\nPatient-Centered Methadone Treatment: Unlike in treatment as usual, counseling will be encouraged but not required and counselors will be responsible for enforcing the clinic's rules. The rules will be enforced by the Clinical Director. Clinic rules will be modified such that involuntary discharge from treatment will be a rare event."}, {'id': 'OG001', 'title': 'Methadone Treatment as Usual', 'description': 'Methadone treatment provided as usual in the U.S.\n\nMethadone Treatment as usual: Counseling will be required and counselors will enforce the usual clinic rules. Involuntary discharge may occur for ongoing drug use or rule infractions as usually occurs in the clinic.'}], 'classes': [{'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.21', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12-months post-baseline', 'description': 'Number of participants meeting DSM-IV cocaine dependence criteria', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Baseline values were used when 12 month data were missing'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Patient-Centered Methadone Treatment', 'description': "Patient-Centered Methadone Treatment alters the rules and staff roles in methadone treatment as usual in an attempt to increase treatment retention and improve patient outcomes.\n\nPatient-Centered Methadone Treatment: Unlike in treatment as usual, counseling will be encouraged but not required and counselors will be responsible for enforcing the clinic's rules. The rules will be enforced by the Clinical Director. Clinic rules will be modified such that involuntary discharge from treatment will be a rare event."}, {'id': 'FG001', 'title': 'Methadone Treatment as Usual', 'description': 'Methadone treatment provided as usual in the U.S.\n\nMethadone Treatment as usual: Counseling will be required and counselors will enforce the usual clinic rules. Involuntary discharge may occur for ongoing drug use or rule infractions as usually occurs in the clinic.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '149'}, {'groupId': 'FG001', 'numSubjects': '151'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '146'}, {'groupId': 'FG001', 'numSubjects': '149'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'withdrawn from study', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'BG000'}, {'value': '149', 'groupId': 'BG001'}, {'value': '295', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Patient-Centered Methadone Treatment', 'description': "Patient-Centered Methadone Treatment alters the rules and staff roles in methadone treatment as usual in an attempt to increase treatment retention and improve patient outcomes.\n\nPatient-Centered Methadone Treatment: Unlike in treatment as usual, counseling will be encouraged but not required and counselors will be responsible for enforcing the clinic's rules. The rules will be enforced by the Clinical Director. Clinic rules will be modified such that involuntary discharge from treatment will be a rare event."}, {'id': 'BG001', 'title': 'Methadone Treatment as Usual', 'description': 'Methadone treatment provided as usual in the U.S.\n\nMethadone Treatment as usual: Counseling will be required and counselors will enforce the usual clinic rules. Involuntary discharge may occur for ongoing drug use or rule infractions as usually occurs in the clinic.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '43.5', 'spread': '10.3', 'groupId': 'BG000'}, {'value': '42.0', 'spread': '9.8', 'groupId': 'BG001'}, {'value': '42.7', 'spread': '10.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '121', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '92', 'groupId': 'BG000'}, {'value': '82', 'groupId': 'BG001'}, {'value': '174', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Black', 'categories': [{'measurements': [{'value': '90', 'groupId': 'BG000'}, {'value': '81', 'groupId': 'BG001'}, {'value': '171', 'groupId': 'BG002'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '122', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '146', 'groupId': 'BG000'}, {'value': '149', 'groupId': 'BG001'}, {'value': '295', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 300}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-12-05', 'studyFirstSubmitDate': '2011-09-07', 'resultsFirstSubmitDate': '2017-02-01', 'studyFirstSubmitQcDate': '2011-09-27', 'lastUpdatePostDateStruct': {'date': '2017-12-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-06-29', 'studyFirstPostDateStruct': {'date': '2011-09-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-09-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Opiate Positive Urine Tests', 'timeFrame': '12-months post-baseline', 'description': 'Number of participants with opiate positive urine tests'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Cocaine Positive Urine Tests', 'timeFrame': '12-months post-baseline', 'description': 'Cocaine positive urine drug test'}, {'measure': 'Drug Use HIV Risk Behavior', 'timeFrame': '12-months post-baseline', 'description': 'HIV Drug Use Risk Assessment Battery Score ranges from 0 to 22. A higher score is considered to be associated with higher risk.'}, {'measure': 'Criminal Behavior', 'timeFrame': '12-months post-baseline', 'description': 'Days of criminal behavior'}, {'measure': 'Global Score on the World Health Organization Quality of Life Measure', 'timeFrame': '12-months post-baseline', 'description': 'Scale from 1 through 5. A higher score reflects a better quality of life.'}, {'measure': 'Number of Participants Meeting DSM-IV Opiate Dependence Criteria', 'timeFrame': '12-months post-baseline', 'description': 'Diagnostic and Statistical Manual (DSM)-IV criteria for opiate dependence'}, {'measure': 'Number of Participants Meeting DSM-IV Cocaine Dependence Criteria', 'timeFrame': '12-months post-baseline', 'description': 'Number of participants meeting DSM-IV cocaine dependence criteria'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Methadone Treatment', 'Opiate dependence', 'Services research'], 'conditions': ['Opiate Dependence']}, 'referencesModule': {'references': [{'pmid': '29536342', 'type': 'DERIVED', 'citation': "Mitchell SG, Monico LB, Lertch E, Kelly SM, Gryczynski J, Jaffe JH, O'Grady KE, Schwartz RP. Counseling Staff's Views of Patient-Centered Methadone Treatment: Changing Program Rules and Staff Roles. J Behav Health Serv Res. 2018 Jul;45(3):506-515. doi: 10.1007/s11414-018-9603-1."}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to determine whether a change in the rules and staff roles in methadone treatment programs will result in greater lengths of stay in treatment and lower rates of heroin and cocaine use, crime and HIV-risk behavior as compared to methadone treatment as usual.', 'detailedDescription': 'Early drop-out and premature discharge from methadone treatment is common in the United States and may be associated with drug use and its associated problems. The purpose of this study is to evaluate the effectiveness of a novel approach to the organization methadone treatment in which the patient rules and staff roles of the clinic will be modified for study participants as compared to patients receiving standard methadone treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* opiate dependence\n* newly admitted to methadone treatment\n\nExclusion Criteria:\n\n* pregnancy'}, 'identificationModule': {'nctId': 'NCT01442493', 'briefTitle': 'Reengineering Methadone Treatment Study of Patient-centered Methadone Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Friends Research Institute, Inc.'}, 'officialTitle': 'Reengineering Methadone Treatment: A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': '2R01DA015842', 'link': 'https://reporter.nih.gov/quickSearch/2R01DA015842', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patient-Centered Methadone Treatment', 'description': 'Patient-Centered Methadone Treatment alters the rules and staff roles in methadone treatment as usual in an attempt to increase treatment retention and improve patient outcomes.', 'interventionNames': ['Other: Patient-Centered Methadone Treatment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Methadone Treatment as Usual', 'description': 'Methadone treatment provided as usual in the U.S.', 'interventionNames': ['Other: Methadone Treatment as usual']}], 'interventions': [{'name': 'Patient-Centered Methadone Treatment', 'type': 'OTHER', 'description': "Unlike in treatment as usual, counseling will be encouraged but not required and counselors will be responsible for enforcing the clinic's rules. The rules will be enforced by the Clinical Director. Clinic rules will be modified such that involuntary discharge from treatment will be a rare event.", 'armGroupLabels': ['Patient-Centered Methadone Treatment']}, {'name': 'Methadone Treatment as usual', 'type': 'OTHER', 'description': 'Counseling will be required and counselors will enforce the usual clinic rules. Involuntary discharge may occur for ongoing drug use or rule infractions as usually occurs in the clinic.', 'armGroupLabels': ['Methadone Treatment as Usual']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21218', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Institutes for Behavior Resources REACH', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '21223', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'University of Maryland Drug Treatment Center', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Robert P Schwartz, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Friends Research Institute, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Friends Research Institute, Inc.', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}