Ignite Creation Date:
2025-12-24 @ 2:25 PM
Ignite Modification Date:
2026-01-02 @ 3:29 AM
Study NCT ID:
NCT04024059
Status:
COMPLETED
Last Update Posted:
2025-03-12
First Post:
2019-07-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Contingency Management to Enhance Office-Based Buprenorphine 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': 'ksilverm@jhmi.edu', 'phone': '4436176051', 'title': 'Kenneth Silverman, Ph.D.', 'organization': 'Johns Hopkins University School of Medicine'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '12 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Buprenorphine Adherence and Opiate Abstinence', 'description': 'Participants will receive financial incentives for buprenorphine use and opiate abstinence.\n\nContingency Management for adherence: Incentives contingent on buprenorphine adherence\n\nContingency Management for abstinence: Incentives contingent on opiate abstinence', 'otherNumAtRisk': 123, 'deathsNumAtRisk': 123, 'otherNumAffected': 0, 'seriousNumAtRisk': 123, 'deathsNumAffected': 1, 'seriousNumAffected': 5}, {'id': 'EG001', 'title': 'Buprenorphine Adherence Only', 'description': 'Participants will receive financial incentives for buprenorphine use.\n\nContingency Management for adherence: Incentives contingent on buprenorphine adherence', 'otherNumAtRisk': 128, 'deathsNumAtRisk': 128, 'otherNumAffected': 0, 'seriousNumAtRisk': 128, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG002', 'title': 'Control', 'description': 'Participants will not receive any intervention.', 'otherNumAtRisk': 124, 'deathsNumAtRisk': 124, 'otherNumAffected': 0, 'seriousNumAtRisk': 124, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'seriousEvents': [{'term': 'Breast Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 128, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 124, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Assault', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 128, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 124, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Covid', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 128, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 124, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'endocarditis with heart surgery for pace maker', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 128, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 124, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 128, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 124, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Psychiatric', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 128, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 124, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 128, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 124, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'blood clot in lungs', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 128, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 124, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 128, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 124, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Buprenorphine Adherence as Assessed by the Percentage of Buprenorphine-positive Urine Samples', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '124', 'groupId': 'OG002'}]}, {'units': 'urine samples', 'counts': [{'value': '369', 'groupId': 'OG000'}, {'value': '384', 'groupId': 'OG001'}, {'value': '372', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Buprenorphine Adherence and Opiate Abstinence', 'description': 'Participants will receive financial incentives for buprenorphine use and opiate abstinence.\n\nContingency Management for adherence: Incentives contingent on buprenorphine adherence\n\nContingency Management for abstinence: Incentives contingent on opiate abstinence'}, {'id': 'OG001', 'title': 'Buprenorphine Adherence Only', 'description': 'Participants will receive financial incentives for buprenorphine use.\n\nContingency Management for adherence: Incentives contingent on buprenorphine adherence'}, {'id': 'OG002', 'title': 'Control', 'description': 'Participants will not receive any intervention.'}], 'classes': [{'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '=0.22', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.737', 'ciLowerLimit': '0.719', 'ciUpperLimit': '4.195', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '=0.938', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.035', 'ciLowerLimit': '0.435', 'ciUpperLimit': '2.461', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks', 'description': 'This will be assessed by the percentage of buprenorphine-positive urine samples during the 12-week intervention.', 'unitOfMeasure': 'percentage of urine samples', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'urine samples', 'denomUnitsSelected': 'urine samples'}, {'type': 'PRIMARY', 'title': 'Opiate Abstinence as Assessed by the Percentage of Opiate-negative Urine Samples', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '124', 'groupId': 'OG002'}]}, {'units': 'urine samples', 'counts': [{'value': '369', 'groupId': 'OG000'}, {'value': '384', 'groupId': 'OG001'}, {'value': '372', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Buprenorphine Adherence and Opiate Abstinence', 'description': 'Participants will receive financial incentives for buprenorphine use and opiate abstinence.\n\nContingency Management for adherence: Incentives contingent on buprenorphine adherence\n\nContingency Management for abstinence: Incentives contingent on opiate abstinence'}, {'id': 'OG001', 'title': 'Buprenorphine Adherence Only', 'description': 'Participants will receive financial incentives for buprenorphine use.\n\nContingency Management for adherence: Incentives contingent on buprenorphine adherence'}, {'id': 'OG002', 'title': 'Control', 'description': 'Participants will not receive any intervention.'}], 'classes': [{'categories': [{'measurements': [{'value': '83', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '=0.202', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.783', 'ciLowerLimit': '0.733', 'ciUpperLimit': '4.336', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '=.474', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.38', 'ciLowerLimit': '0.571', 'ciUpperLimit': '3.336', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks', 'description': 'This will be assessed by the percentage of opiate-negative urine samples during the 12-week intervention.', 'unitOfMeasure': 'percentage of urine samples', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'urine samples', 'denomUnitsSelected': 'urine samples'}, {'type': 'SECONDARY', 'title': 'Buprenorphine Diversion as Assessed by Percentage of Participants Reporting Any Diversion of Buprenorphine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '124', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Buprenorphine Adherence and Opiate Abstinence', 'description': 'Participants will receive financial incentives for buprenorphine use and opiate abstinence.\n\nContingency Management for adherence: Incentives contingent on buprenorphine adherence\n\nContingency Management for abstinence: Incentives contingent on opiate abstinence'}, {'id': 'OG001', 'title': 'Buprenorphine Adherence Only', 'description': 'Participants will receive financial incentives for buprenorphine use.\n\nContingency Management for adherence: Incentives contingent on buprenorphine adherence'}, {'id': 'OG002', 'title': 'Control', 'description': 'Participants will not receive any intervention.'}], 'classes': [{'categories': [{'measurements': [{'value': '16.12', 'groupId': 'OG000'}, {'value': '16.28', 'groupId': 'OG001'}, {'value': '18.82', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '=0.328', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.669', 'ciLowerLimit': '0.299', 'ciUpperLimit': '1.497', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '=0.435', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.724', 'ciLowerLimit': '0.322', 'ciUpperLimit': '1.627', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks', 'description': 'This is the percentage of participants reporting any diversion of buprenorphine at each assessment during the 12-week intervention.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Buprenorphine Adherence and Opiate Abstinence', 'description': 'Participants will receive financial incentives for buprenorphine use and opiate abstinence.\n\nContingency Management for adherence: Incentives contingent on buprenorphine adherence\n\nContingency Management for abstinence: Incentives contingent on opiate abstinence'}, {'id': 'FG001', 'title': 'Buprenorphine Adherence Only', 'description': 'Participants will receive financial incentives for buprenorphine use.\n\nContingency Management for adherence: Incentives contingent on buprenorphine adherence'}, {'id': 'FG002', 'title': 'Control', 'description': 'Participants will not receive any intervention.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '123'}, {'groupId': 'FG001', 'numSubjects': '128'}, {'groupId': 'FG002', 'numSubjects': '124'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '112'}, {'groupId': 'FG001', 'numSubjects': '126'}, {'groupId': 'FG002', 'numSubjects': '119'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '5'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'BG000'}, {'value': '128', 'groupId': 'BG001'}, {'value': '124', 'groupId': 'BG002'}, {'value': '375', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Buprenorphine Adherence and Opiate Abstinence', 'description': 'Participants will receive financial incentives for buprenorphine use and opiate abstinence.\n\nContingency Management for adherence: Incentives contingent on buprenorphine adherence\n\nContingency Management for abstinence: Incentives contingent on opiate abstinence'}, {'id': 'BG001', 'title': 'Buprenorphine Adherence Only', 'description': 'Participants will receive financial incentives for buprenorphine use.\n\nContingency Management for adherence: Incentives contingent on buprenorphine adherence'}, {'id': 'BG002', 'title': 'Control', 'description': 'Participants will not receive any intervention.'}, {'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': '119', 'groupId': 'BG000'}, {'value': '127', 'groupId': 'BG001'}, {'value': '124', 'groupId': 'BG002'}, {'value': '370', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '42', 'spread': '11', 'groupId': 'BG000'}, {'value': '42', 'spread': '10', 'groupId': 'BG001'}, {'value': '41', 'spread': '10', 'groupId': 'BG002'}, {'value': '42', 'spread': '10', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}, {'value': '151', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '82', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '76', 'groupId': 'BG002'}, {'value': '224', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '122', 'groupId': 'BG000'}, {'value': '126', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}, {'value': '368', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}, {'value': '93', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '82', 'groupId': 'BG000'}, {'value': '97', 'groupId': 'BG001'}, {'value': '84', 'groupId': 'BG002'}, {'value': '263', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '123', 'groupId': 'BG000'}, {'value': '128', 'groupId': 'BG001'}, {'value': '124', 'groupId': 'BG002'}, {'value': '375', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-04-12', 'size': 470132, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-12-05T17:17', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 375}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2024-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-06', 'studyFirstSubmitDate': '2019-07-16', 'resultsFirstSubmitDate': '2025-01-08', 'studyFirstSubmitQcDate': '2019-07-16', 'lastUpdatePostDateStruct': {'date': '2025-03-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-03-06', 'studyFirstPostDateStruct': {'date': '2019-07-18', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-03-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Buprenorphine Adherence as Assessed by the Percentage of Buprenorphine-positive Urine Samples', 'timeFrame': '12 weeks', 'description': 'This will be assessed by the percentage of buprenorphine-positive urine samples during the 12-week intervention.'}, {'measure': 'Opiate Abstinence as Assessed by the Percentage of Opiate-negative Urine Samples', 'timeFrame': '12 weeks', 'description': 'This will be assessed by the percentage of opiate-negative urine samples during the 12-week intervention.'}], 'secondaryOutcomes': [{'measure': 'Buprenorphine Diversion as Assessed by Percentage of Participants Reporting Any Diversion of Buprenorphine', 'timeFrame': '12 weeks', 'description': 'This is the percentage of participants reporting any diversion of buprenorphine at each assessment during the 12-week intervention.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Opioid-use Disorder']}, 'descriptionModule': {'briefSummary': 'Contingency Management interventions provide incentives to substance abuse patients when patients meet therapeutic goals. This project will compare the effectiveness of two Contingency Management interventions (which the investigators have named "Buprenorphine Adherence and Opiate Abstinence" and "Buprenorphine Adherence Only") and Standard Medical Management for treating adults with opioid use disorder. Participants (N=375) will be randomly assigned to one of the three groups. Buprenorphine Adherence and Opiate Abstinence and Buprenorphine Adherence Only participants will receive incentives for daily buprenorphine use. Buprenorphine Adherence and Opiate Abstinence participants also will receive incentives for providing opiate-negative saliva samples. Daily buprenorphine use and opiate abstinence will both be remotely verified using smartphone-enabled video directly observed therapy (Video DOT). All participants will be receiving or referred to receive buprenorphine treatment and will complete assessments every 4 weeks during a 12-week intervention period.', 'detailedDescription': 'Opioid use has increased to epidemic levels in the United States and has been associated with a dramatic increase in overdose deaths. Buprenorphine is a safe, well-tolerated, and evidence-based medication for opioid use disorder that can be prescribed in office-based treatment settings. Office-based buprenorphine could be an effective way to expand treatment for opioid use disorder, and thereby combat the opioid epidemic. However, office-based buprenorphine has three limitations that must be addressed to facilitate the safe and effective expansion of buprenorphine treatment: 1) Many patients discontinue buprenorphine treatment prematurely, 2) some patients divert buprenorphine for illicit use, and 3) many patients continue to use illicit opioids during buprenorphine treatment. This project will address these limitations by using a psychosocial approach known as Contingency Management. Contingency Management interventions provide incentives to substance abuse patients when patients meet therapeutic goals. This project will compare the effectiveness of two Contingency Management interventions (which the investigators have named "Buprenorphine Adherence and Opiate Abstinence" and "Buprenorphine Adherence Only") and Standard Medical Management for treating adults with opioid use disorder. Participants (N=375) will be randomly assigned to one of the three groups. Buprenorphine Adherence and Opiate Abstinence and Buprenorphine Adherence Only participants will receive incentives for daily buprenorphine use. Buprenorphine Adherence and Opiate Abstinence participants also will receive incentives for providing opiate-negative saliva samples. Daily buprenorphine use and opiate abstinence will both be remotely verified using smartphone-enabled video directly observed therapy (Video DOT). All participants will be receiving or referred to receive buprenorphine treatment and will complete assessments every 4 weeks during a 12-week intervention period. If the proposed intervention is effective, it could encourage medical professionals to prescribe buprenorphine, and improve patients\' access to and success in office-based buprenorphine treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Opioid use disorder\n* Enrolled in buprenorphine treatment\n\nExclusion Criteria:\n\n* Unwilling or unable to use a smartphone'}, 'identificationModule': {'nctId': 'NCT04024059', 'briefTitle': 'Contingency Management to Enhance Office-Based Buprenorphine Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins University'}, 'officialTitle': 'Contingency Management to Enhance Office-Based Buprenorphine Treatment', 'orgStudyIdInfo': {'id': 'IRB00220692'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Buprenorphine Adherence and Opiate Abstinence', 'description': 'Participants will receive financial incentives for buprenorphine use and opiate abstinence.', 'interventionNames': ['Behavioral: Contingency Management for adherence', 'Behavioral: Contingency Management for abstinence']}, {'type': 'EXPERIMENTAL', 'label': 'Buprenorphine Adherence Only', 'description': 'Participants will receive financial incentives for buprenorphine use.', 'interventionNames': ['Behavioral: Contingency Management for adherence']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Participants will not receive any intervention.'}], 'interventions': [{'name': 'Contingency Management for adherence', 'type': 'BEHAVIORAL', 'description': 'Incentives contingent on buprenorphine adherence', 'armGroupLabels': ['Buprenorphine Adherence Only', 'Buprenorphine Adherence and Opiate Abstinence']}, {'name': 'Contingency Management for abstinence', 'type': 'BEHAVIORAL', 'description': 'Incentives contingent on opiate abstinence', 'armGroupLabels': ['Buprenorphine Adherence and Opiate Abstinence']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21224', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Center for Learning and Health', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Kenneth Silverman, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Patient-Centered Outcomes Research Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}