Ignite Creation Date:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2026-01-02 @ 8:48 AM
Study NCT ID:
NCT04240093
Status:
COMPLETED
Last Update Posted:
2023-05-26
First Post:
2020-01-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
CoMBAT Opioid Use Disorder: A Combined Medication and Behavioral Activation Treatment for People Living With Opioid Use Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009293', 'term': 'Opioid-Related Disorders'}, {'id': 'D055118', 'term': 'Medication Adherence'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}], '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': 'D010349', 'term': 'Patient Compliance'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004304', 'term': 'Dosage Forms'}], 'ancestors': [{'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D013678', 'term': 'Technology, Pharmaceutical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jaclyn_hughto@brown.edu', 'phone': '401-863-6580', 'title': 'Jaclyn White Hughto, PhD, MPH', 'organization': 'Brown University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '6 Months', 'eventGroups': [{'id': 'EG000', 'title': 'Experimental', 'description': 'Experimental: Behavioral Activation (8 sessions) + Substance Abuse and Health Navigation Counseling (2 sessions) + Meds\n\nBehavioral Activation (BA) Therapy: 8 sessions of behavioral activation therapy\n\nSubstance Abuse and Health Navigation Counseling: 2 standard substance abuse and health navigation counseling\n\nMedications for Opioid Use Disorder: Medications for opioid use disorder (i.e., buprenorphine and methadone) as prescribed by a community provider (not provided as part of the study).', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 0, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Standard of Care', 'description': 'Substance Abuse and Health Navigation Counseling (2 sessions) + Meds\n\nSubstance Abuse and Health Navigation Counseling: 2 standard substance abuse and health navigation counseling\n\nMedications for Opioid Use Disorder: Medications for opioid use disorder (i.e., buprenorphine and methadone) as prescribed by a community provider (not provided as part of the study).', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 0, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Missed Medication Doses - Past 30 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CoMBAT (Experimental)', 'description': 'Experimental: Behavioral Activation (8 sessions) + Substance Abuse and Health Navigation Counseling (2 sessions) + Meds\n\nBehavioral Activation (BA) Therapy: 8 sessions of behavioral activation therapy\n\nSubstance Abuse and Health Navigation Counseling: 2 standard substance abuse and health navigation counseling\n\nMedications for Opioid Use Disorder: Medications for opioid use disorder (i.e., buprenorphine and methadone) as prescribed by a community provider (not provided as part of the study).'}, {'id': 'OG001', 'title': 'Standard of Care (SOC; Control)', 'description': 'Substance Abuse and Health Navigation Counseling (2 sessions) + Meds\n\nSubstance Abuse and Health Navigation Counseling: 2 standard substance abuse and health navigation counseling\n\nMedications for Opioid Use Disorder: Medications for opioid use disorder (i.e., buprenorphine and methadone) as prescribed by a community provider (not provided as part of the study).'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.13', 'spread': '3.48', 'groupId': 'OG000'}, {'value': '2.81', 'spread': '3.00', 'groupId': 'OG001'}]}]}, {'title': '3 Month Follow-Up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.71', 'spread': '4.41', 'groupId': 'OG000'}, {'value': '2.25', 'spread': '3.00', 'groupId': 'OG001'}]}]}, {'title': '6 Month Follow-Up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.19', 'spread': '2.43', 'groupId': 'OG000'}, {'value': '1.69', 'spread': '4.29', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.17', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Beta coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.46', 'ciLowerLimit': '-1.11', 'ciUpperLimit': '0.20', 'pValueComment': 'a priori alpha p\\<0.05', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.33', 'groupDescription': 'Hypothesis: The CoMBAT intervention arm would be superior to the Standard of Care control arm with regard to reductions in missed medication doses in the past 30 days at follow-up.', 'statisticalMethod': 'Generalized estimating equations (GEE)', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Generalized estimating equations (GEE) with a poisson distribution controlling for baseline values.', 'nonInferiorityComment': 'This is a pilot intervention trial and was not powered to detect statistical significance.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 3 month follow-up, and 6 month follow-up', 'description': 'Self-reported change in the number of missed methadone or buprenorphine doses in the past 30 days. Raw, unadjusted means at 6-month follow-up are reported.', 'unitOfMeasure': 'Number of missed doses', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat Analysis. For the unadjusted means by time-point data, there were missing data for 2 participants in the CoMBAT experimental arm at the 3-month follow-up visit.'}, {'type': 'PRIMARY', 'title': 'Number of Missed Medication-related Visits - Past 30 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CoMBAT (Experimental)', 'description': 'Experimental: Behavioral Activation (8 sessions) + Substance Abuse and Health Navigation Counseling (2 sessions) + Meds\n\nBehavioral Activation (BA) Therapy: 8 sessions of behavioral activation therapy\n\nSubstance Abuse and Health Navigation Counseling: 2 standard substance abuse and health navigation counseling\n\nMedications for Opioid Use Disorder: Medications for opioid use disorder (i.e., buprenorphine and methadone) as prescribed by a community provider (not provided as part of the study).'}, {'id': 'OG001', 'title': 'Standard of Care (SOC; Control)', 'description': 'Substance Abuse and Health Navigation Counseling (2 sessions) + Meds\n\nSubstance Abuse and Health Navigation Counseling: 2 standard substance abuse and health navigation counseling\n\nMedications for Opioid Use Disorder: Medications for opioid use disorder (i.e., buprenorphine and methadone) as prescribed by a community provider (not provided as part of the study).'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.13', 'spread': '1.20', 'groupId': 'OG000'}, {'value': '0.94', 'spread': '0.85', 'groupId': 'OG001'}]}]}, {'title': '3 Month Follow-Up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.14', 'spread': '0.36', 'groupId': 'OG000'}, {'value': '0.25', 'spread': '0.45', 'groupId': 'OG001'}]}]}, {'title': '6 Month Follow-Up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.06', 'spread': '0.03', 'groupId': 'OG000'}, {'value': '0.06', 'spread': '0.35', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.90', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Beta coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.18', 'ciLowerLimit': '-3.09', 'ciUpperLimit': '2.72', 'pValueComment': 'a priori alpha p\\<0.05', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.48', 'groupDescription': 'Hypothesis: The CoMBAT intervention arm would be superior to the Standard of Care control arm with regard to reductions in missed medication-related visits in the past 30 days at follow-up.', 'statisticalMethod': 'Generalized estimating equation (GEE)', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Generalized estimating equations (GEE) with a Poisson distribution controlling for baseline values.', 'nonInferiorityComment': 'This pilot feasibility and acceptability study was not powered to detect a statistically significant effect.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 3 month follow-up, and 6 month follow-up', 'description': 'Self-reported change in the number of medication-related clinic visits missed in the past 30 days from baseline to follow-up.', 'unitOfMeasure': 'Number of missed visits', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat Analysis. For the unadjusted means by time-point data, there were missing data for 2 participants in the CoMBAT experimental arm at the 3-month follow-up visit.'}, {'type': 'SECONDARY', 'title': 'Fentanyl and Opiate-positive Urine Toxicology Screen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CoMBAT (Experimental)', 'description': 'Experimental: Behavioral Activation (8 sessions) + Substance Abuse and Health Navigation Counseling (2 sessions) + Meds\n\nBehavioral Activation (BA) Therapy: 8 sessions of behavioral activation therapy\n\nSubstance Abuse and Health Navigation Counseling: 2 standard substance abuse and health navigation counseling\n\nMedications for Opioid Use Disorder: Medications for opioid use disorder (i.e., buprenorphine and methadone) as prescribed by a community provider (not provided as part of the study).'}, {'id': 'OG001', 'title': 'Standard of Care (SOC; Control)', 'description': 'Substance Abuse and Health Navigation Counseling (2 sessions) + Meds\n\nSubstance Abuse and Health Navigation Counseling: 2 standard substance abuse and health navigation counseling\n\nMedications for Opioid Use Disorder: Medications for opioid use disorder (i.e., buprenorphine and methadone) as prescribed by a community provider (not provided as part of the study).'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': '3 Month Follow-Up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': '6 Month Follow-Up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.02', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Beta coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.71', 'ciLowerLimit': '-8.72', 'ciUpperLimit': '-0.70', 'pValueComment': 'A priori alpha p\\<0.05', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.05', 'groupDescription': 'Hypothesis: Fewer participants in the CoMBAT experimental arm will have a positive opioid toxicology screen at the 6-month follow-up compared to participants in the SOC control arm.', 'statisticalMethod': 'Generalized estimating equations (GEE)', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Generalized estimating equation (GEE) modeling with a binomial distribution, controlling for baseline values.', 'nonInferiorityComment': 'As a pilot feasibility and acceptability trial, this study was not powered to detect a statistically significant effect.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, 3 month follow-up, and 6 month follow-up', 'description': 'Fentanyl or opiate-positive urine screen (opiates refer to natural opioids such as heroin, morphine so buprenorphine, methadone, and other synthetic opioids are not included)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat Analysis. For the raw count data, there were missing data for 2 participants in the CoMBAT experimental arm at the 3-month follow-up visit.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Experimental', 'description': 'Experimental: Behavioral Activation (8 sessions) + Substance Abuse and Health Navigation Counseling (2 sessions) + Meds\n\nBehavioral Activation (BA) Therapy: 8 sessions of behavioral activation therapy\n\nSubstance Abuse and Health Navigation Counseling: 2 standard substance abuse and health navigation counseling\n\nMedications for Opioid Use Disorder: Medications for opioid use disorder (i.e., buprenorphine and methadone) as prescribed by a community provider (not provided as part of the study).'}, {'id': 'FG001', 'title': 'Standard of Care', 'description': 'Substance Abuse and Health Navigation Counseling (2 sessions) + Meds\n\nSubstance Abuse and Health Navigation Counseling: 2 standard substance abuse and health navigation counseling\n\nMedications for Opioid Use Disorder: Medications for opioid use disorder (i.e., buprenorphine and methadone) as prescribed by a community provider (not provided as part of the study).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': '3 Month Follow-Up', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': '6 Month Follow Up', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants were recruited via ads posted online (i.e., Craigslist) and in-person at outpatient substance use treatment clinics and community organizations serving people who use drugs in Rhode Island and Massachusetts. Substance use treatment providers and staff also provided direct referrals and snowball sampling was used.', 'preAssignmentDetails': 'A total of 44 individuals consented; of these, 12 individuals were lost to follow-up prior to randomization, resulting in a randomized sample of 32 participants (16 CoMBAT experimental arm; 16 Standard of Care control arm).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Experimental', 'description': 'Experimental: Behavioral Activation (8 sessions) + Substance Abuse and Health Navigation Counseling (2 sessions) + Meds\n\nBehavioral Activation (BA) Therapy: 8 sessions of behavioral activation therapy\n\nSubstance Abuse and Health Navigation Counseling: 2 standard substance abuse and health navigation counseling\n\nMedications for Opioid Use Disorder: Medications for opioid use disorder (i.e., buprenorphine and methadone) as prescribed by a community provider (not provided as part of the study).'}, {'id': 'BG001', 'title': 'Standard of Care', 'description': 'Substance Abuse and Health Navigation Counseling (2 sessions) + Meds\n\nSubstance Abuse and Health Navigation Counseling: 2 standard substance abuse and health navigation counseling\n\nMedications for Opioid Use Disorder: Medications for opioid use disorder (i.e., buprenorphine and methadone) as prescribed by a community provider (not provided as part of the study).'}, {'id': 'BG002', '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'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '39.9', 'spread': '10.98', 'groupId': 'BG000'}, {'value': '39.4', 'spread': '11.6', 'groupId': 'BG001'}, {'value': '39.6', 'spread': '11.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Medication Type', 'classes': [{'categories': [{'title': 'Methadone', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}, {'title': 'Buprenorphine', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Baseline data are reported for all enrolled and randomized participants (n=32).'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-03-14', 'size': 149914, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-12-01T10:27', 'hasProtocol': True}, {'date': '2023-04-21', 'size': 55417, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_002.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-05-23T12:22', 'hasProtocol': False}, {'date': '2020-12-14', 'size': 162097, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2021-12-01T10:27', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Two-arm RTC, randomized 1:1 to two arms: (1) the CoMBAT intervention (behavioral activation and substance abuse/health navigation) counseling, which lasts ten sessions; and (2) the standard of care comparison condition, including two equivalent substance abuse/ health navigation counseling sessions.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-11-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2022-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-25', 'studyFirstSubmitDate': '2020-01-21', 'resultsFirstSubmitDate': '2023-04-26', 'studyFirstSubmitQcDate': '2020-01-21', 'lastUpdatePostDateStruct': {'date': '2023-05-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-05-25', 'studyFirstPostDateStruct': {'date': '2020-01-27', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-05-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Missed Medication Doses - Past 30 Days', 'timeFrame': 'Baseline, 3 month follow-up, and 6 month follow-up', 'description': 'Self-reported change in the number of missed methadone or buprenorphine doses in the past 30 days. Raw, unadjusted means at 6-month follow-up are reported.'}, {'measure': 'Number of Missed Medication-related Visits - Past 30 Days', 'timeFrame': 'Baseline, 3 month follow-up, and 6 month follow-up', 'description': 'Self-reported change in the number of medication-related clinic visits missed in the past 30 days from baseline to follow-up.'}], 'secondaryOutcomes': [{'measure': 'Fentanyl and Opiate-positive Urine Toxicology Screen', 'timeFrame': 'Baseline, 3 month follow-up, and 6 month follow-up', 'description': 'Fentanyl or opiate-positive urine screen (opiates refer to natural opioids such as heroin, morphine so buprenorphine, methadone, and other synthetic opioids are not included)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Medications for opioid use disorder', 'Methadone', 'Buprenorphine', 'Behavioral Activation'], 'conditions': ['Opioid-use Disorder', 'Medication Adherence', 'Health Care Utilization']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.fresh-research.com', 'label': 'FRESH Research Lab'}]}, 'descriptionModule': {'briefSummary': 'This study seeks primarily to test, in a two-arm randomized controlled trial (RCT), the feasibility, acceptability, and preliminary efficacy of CoMBAT OUD, an intervention that integrates Behavioral Activation (BA) and substance abuse and health navigation counseling for individuals who are receiving medications for opioid use disorder (i.e., methadone; suboxone) to help them improve engagement in care and opioid use treatment outcomes. Participants will be randomized 1:1 to two arms: (1) the CoMBAT intervention (2 sessions of substance abuse and health navigation counseling + 8 sessions of BA counseling); or the (3) the standard of care (SOC) comparison condition, including two equivalent substance abuse and health navigation counseling. Participants will be followed for 6 months post-randomization, with assessments at months 3 and 6.', 'detailedDescription': 'Opioid use disorder (OUD) is a chronic, relapsing disease and a major source of morbidity and mortality in the United States. Medications for opioid use disorder (i.e., methadone; buprenorphine) have been shown to reduce opioid use in diverse populations; however, long-term use of these medications and engagement in care are often suboptimal. Depression has been shown to contribute to medication discontinuation and care disengagement. Behavioral activation (BA) therapy is an evidence-based, behavioral treatment that has been shown to be effective in treating comorbid depression and substance use in diverse populations with smoking, alcohol, stimulant, and poly-substance use disorder. BA utilizes therapeutic techniques that help patients gradually increase goal-directed, potentially rewarding and pleasurable activities while decreasing the intensity and frequency of adverse events and consequences in order to improve mood. Given that BA utilizes strategies that can support individuals in alleviating depression and build the capacity to navigate life challenges, pairing BA with medications for OUD could help to ensure continued engagement in care and improve OUD treatment outcomes.\n\nThis study, therefore, seeks to determine the feasibility of study procedures, enhance participant acceptability, and demonstrate preliminary efficacy of the CoMBAT (Combined Medication and Behavioral Activation Treatment) intervention. The investigators will enroll individuals currently being treated with methadone or buprenorphine for OUD in a pilot randomized controlled trial (RCT) of the CoMBAT intervention. Prior to randomization, participants will receive 2 health navigation and standard substance abuse counseling sessions. Participants will then be equally randomized to either: 1) the 8-session CoMBAT intervention; or 2) standard of care. The primary outcome is engagement in care. Secondary outcomes include self-reported days of opioid use and opioid-positive urinalysis. Intervention feasibility and acceptability will also be assessed. Participants will complete major assessment visits (survey and toxicology testing) at baseline and 3- and 6-months post-randomization.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 years or older\n* Initiated medications for opioid use \\>= 30 day prior to screening\n* Current depressive symptoms\n* Plans to stay in Rhode Island or Massachusetts for at least 6-months\n* Able to read, speak, and understand English\n* Willing and able to provide informed consent\n\nExclusion Criteria:\n\n* Does not plan to continue taking medications for opioid use disorder\n* Unable to provide informed consent due to severe mental or physical illness, or substance intoxication at the time of interview\n* Discovery of active suicidal ideation at the time of interview\n* In the second or third trimester of pregnancy'}, 'identificationModule': {'nctId': 'NCT04240093', 'acronym': 'CoMBAT_OUD', 'briefTitle': 'CoMBAT Opioid Use Disorder: A Combined Medication and Behavioral Activation Treatment for People Living With Opioid Use Disorder', 'organization': {'class': 'OTHER', 'fullName': 'Brown University'}, 'officialTitle': 'CoMBAT Opioid Use Disorder: A Pilot Randomized Controlled Trial of a Combined Medication and Behavioral Activation Treatment for People Living With Opioid Use Disorder', 'orgStudyIdInfo': {'id': '1906002463'}, 'secondaryIdInfos': [{'id': 'Junior Investigator Award', 'type': 'OTHER_GRANT', 'domain': 'COBRE on Opioids and Overdose'}, {'id': '5P20GM125507-02', 'link': 'https://reporter.nih.gov/quickSearch/5P20GM125507-02', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental', 'description': 'Experimental: Behavioral Activation (8 sessions) + Substance Abuse and Health Navigation Counseling (2 sessions) + Meds', 'interventionNames': ['Behavioral: Behavioral Activation (BA) Therapy', 'Behavioral: Substance Abuse and Health Navigation Counseling', 'Other: Medications for Opioid Use Disorder']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard of Care', 'description': 'Substance Abuse and Health Navigation Counseling (2 sessions) + Meds', 'interventionNames': ['Behavioral: Substance Abuse and Health Navigation Counseling', 'Other: Medications for Opioid Use Disorder']}], 'interventions': [{'name': 'Behavioral Activation (BA) Therapy', 'type': 'BEHAVIORAL', 'description': '8 sessions of behavioral activation therapy', 'armGroupLabels': ['Experimental']}, {'name': 'Substance Abuse and Health Navigation Counseling', 'type': 'BEHAVIORAL', 'description': '2 standard substance abuse and health navigation counseling', 'armGroupLabels': ['Experimental', 'Standard of Care']}, {'name': 'Medications for Opioid Use Disorder', 'type': 'OTHER', 'description': 'Medications for opioid use disorder (i.e., buprenorphine and methadone) as prescribed by a community provider (not provided as part of the study).', 'armGroupLabels': ['Experimental', 'Standard of Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02912', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Brown University', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}], 'overallOfficials': [{'name': 'Jaclyn W Hughto, PhD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Brown University'}]}, 'ipdSharingStatementModule': {'url': 'http://www.fresh-research.com', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'The first time point at which outside investigators may request IPD will be after all of the baseline data has been collected and internal study staff have been offered the availability to write papers or give presentations on particular topics. A similar process will take place for outcome data following publication and release of the outcome paper(s). The PI will store the data indefinitely.', 'ipdSharing': 'YES', 'description': "Raw data for additional analysis will be available to outside individuals through contacting the Principal Investigator (PI) at two different times. The first will be after all of the baseline data is collected. The PI will institute a concept plan process where internal study staff first have the availability to write papers or give presentations on particular topics. After this, if outside individuals wish to analyze the data, the PI will welcome this collaboration. A similar process will happen for outcome data; however, this will not be possible until the publication and release of the outcome paper(s). The PI will allow access for pooled data analysis projects, or projects for outside individuals. Information regarding the availability of data for analysis will be listed on the PIs' web page. Contact information for the PI will be listed in all manuscripts and publications as another means to access data.", 'accessCriteria': "Raw data for additional analysis will be available to outside individuals by contacting the Principal Investigator (PI). The PI will institute a concept plan process where internal study staff first have the availability to write papers or give presentations on particular topics. After this, if outside individuals wish to analyze data, the PI will welcome this collaboration. The PI will allow access for pooled data analysis projects, or projects for outside individuals. Information regarding the availability of data for analysis will be listed on the PI's web page (see below)."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Brown University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Boston University', 'class': 'OTHER'}, {'name': 'University of Massachusetts, Boston', 'class': 'OTHER'}, {'name': 'National Institute of General Medical Sciences (NIGMS)', 'class': 'NIH'}, {'name': 'Rhode Island Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}