Ignite Creation Date:
2025-12-24 @ 6:26 PM
Ignite Modification Date:
2026-03-05 @ 5:40 PM
Study NCT ID:
NCT02252068
Status:
COMPLETED
Last Update Posted:
2020-11-17
First Post:
2014-09-25
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of Treatment for Opioid Dependence and Anxiety Disorders
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D009293', 'term': 'Opioid-Related Disorders'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D000079524', 'term': 'Narcotic-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kmchugh@mclean.harvard.edu', 'phone': '617-855-2000', 'title': 'Dr. R. Kathryn McHugh', 'organization': 'McLean Hospital'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '6 months', 'eventGroups': [{'id': 'EG000', 'title': 'I-CBT Feasibility Pilot', 'description': 'Open trial of I-CBT\n\nI-CBT: New cognitive behavioral therapy treatment manual developed to treat co-occurring anxiety and opioid dependency disorders.', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 0, 'seriousNumAtRisk': 5, 'deathsNumAffected': 1, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'RCT I-CBT', 'description': 'Randomized controlled trial: Integrated Cognitive-Behavioral Therapy Arm\n\nI-CBT: New cognitive behavioral therapy treatment manual developed to treat co-occurring anxiety and opioid dependency disorders.', 'otherNumAtRisk': 13, 'deathsNumAtRisk': 13, 'otherNumAffected': 0, 'seriousNumAtRisk': 13, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'RCT IDC', 'description': 'Randomized Controlled Trial: Individual Drug Counseling Arm\n\nIDC: Individual Drug Counseling manual that has demonstrated efficacy for the treatment of drug dependence.', 'otherNumAtRisk': 13, 'deathsNumAtRisk': 13, 'otherNumAffected': 0, 'seriousNumAtRisk': 13, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Urine-confirmed Self-reported Weeks of Opioid Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'I-CBT Feasibility Pilot', 'description': 'Open trial of I-CBT\n\nI-CBT: New cognitive behavioral therapy treatment manual developed to treat co-occurring anxiety and opioid dependency disorders.'}, {'id': 'OG001', 'title': 'RCT: I-CBT', 'description': 'Randomized control trial of I-CBT vs ICD\n\nI-CBT: New cognitive behavioral therapy treatment manual developed to treat co-occurring anxiety and opioid dependency disorders.'}, {'id': 'OG002', 'title': 'RCT IDC', 'description': 'Randomized control trial of I-CBT vs ICD\n\nIDC: Individual Drug Counseling manual that has demonstrated efficacy for the treatment of drug dependence.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'spread': '1.73', 'groupId': 'OG000'}, {'value': '.36', 'spread': '1.2', 'groupId': 'OG001'}, {'value': '.31', 'spread': '.85', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 12', 'description': 'Number of weeks of opioid use at Week 12 for the last 4 weeks of treatment (Weeks 9-12), as assessed by self-report and validated by urine drug screen', 'unitOfMeasure': 'weeks', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to partial missing data, the analysis population does not reflect the full sample. Specifically, missing data for 2 participants in RCT: I-CBT arm.'}, {'type': 'PRIMARY', 'title': 'Anxiety Symptom Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'I-CBT Feasibility Pilot', 'description': 'Open trial of I-CBT\n\nI-CBT: New cognitive behavioral therapy treatment manual developed to treat co-occurring anxiety and opioid dependency disorders.'}, {'id': 'OG001', 'title': 'RCT: I-CBT', 'description': 'Randomized control trial of I-CBT vs ICD\n\nI-CBT: New cognitive behavioral therapy treatment manual developed to treat co-occurring anxiety and opioid dependency disorders.'}, {'id': 'OG002', 'title': 'RCT IDC', 'description': 'Randomized control trial of I-CBT vs ICD\n\nIDC: Individual Drug Counseling manual that has demonstrated efficacy for the treatment of drug dependence.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.3', 'spread': '3.1', 'groupId': 'OG000'}, {'value': '14.5', 'spread': '8.2', 'groupId': 'OG001'}, {'value': '13.0', 'spread': '8.4', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 12', 'description': 'Hamilton Anxiety Rating Scale (HADS) score. Measure assesses the severity of anxiety symptoms. Total scale scores are reported. Higher scores reflect worse outcome. The range of possible scores is 0-56.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to partial missing data, not all participants are included in this analysis. Specifically, missing data for 1 participant in the RCT: I-CBT arm.'}, {'type': 'SECONDARY', 'title': 'Quality of Life - General Health Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'I-CBT Feasibility Pilot', 'description': 'Open trial of I-CBT\n\nI-CBT: New cognitive behavioral therapy treatment manual developed to treat co-occurring anxiety and opioid dependency disorders.'}, {'id': 'OG001', 'title': 'RCT: I-CBT', 'description': 'Randomized control trial of I-CBT vs ICD\n\nI-CBT: New cognitive behavioral therapy treatment manual developed to treat co-occurring anxiety and opioid dependency disorders.'}, {'id': 'OG002', 'title': 'RCT IDC', 'description': 'Randomized control trial of I-CBT vs ICD\n\nIDC: Individual Drug Counseling manual that has demonstrated efficacy for the treatment of drug dependence.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.7', 'spread': '2.9', 'groupId': 'OG000'}, {'value': '5.9', 'spread': '1.2', 'groupId': 'OG001'}, {'value': '6.8', 'spread': '1.5', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 12', 'description': 'Assessed by the World Health Organization Quality of Life measure, measure reflects overall health as an indicator of quality of life. The scale range of possible scores is 2-10, with higher scores reflected better outcome (i.e., better general health).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to partial missing data, not all participants are included in this analysis. Specifically 2 people are missing from the RCT:I-CBT arm and 3 from the RCT IDC arm.'}, {'type': 'SECONDARY', 'title': 'Non-opioid Substance Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'I-CBT Feasibility Pilot', 'description': 'Open trial of I-CBT\n\nI-CBT: New cognitive behavioral therapy treatment manual developed to treat co-occurring anxiety and opioid dependency disorders.'}, {'id': 'OG001', 'title': 'RCT: I-CBT', 'description': 'Randomized control trial of I-CBT vs ICD\n\nI-CBT: New cognitive behavioral therapy treatment manual developed to treat co-occurring anxiety and opioid dependency disorders.'}, {'id': 'OG002', 'title': 'RCT IDC', 'description': 'Randomized control trial of I-CBT vs ICD\n\nIDC: Individual Drug Counseling manual that has demonstrated efficacy for the treatment of drug dependence.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.3', 'spread': '16.2', 'groupId': 'OG000'}, {'value': '4.8', 'spread': '9.3', 'groupId': 'OG001'}, {'value': '7.8', 'spread': '13.6', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 12', 'description': 'Days of other substance use in the past 30 days', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Functional Impairment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'I-CBT Feasibility Pilot', 'description': 'Open trial of I-CBT\n\nI-CBT: New cognitive behavioral therapy treatment manual developed to treat co-occurring anxiety and opioid dependency disorders.'}, {'id': 'OG001', 'title': 'RCT: I-CBT', 'description': 'Randomized control trial of I-CBT vs ICD\n\nI-CBT: New cognitive behavioral therapy treatment manual developed to treat co-occurring anxiety and opioid dependency disorders.'}, {'id': 'OG002', 'title': 'RCT IDC', 'description': 'Randomized control trial of I-CBT vs ICD\n\nIDC: Individual Drug Counseling manual that has demonstrated efficacy for the treatment of drug dependence.'}], 'classes': [{'categories': [{'measurements': [{'value': '.15', 'spread': '.14', 'groupId': 'OG000'}, {'value': '.10', 'spread': '.10', 'groupId': 'OG001'}, {'value': '.07', 'spread': '.05', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 12', 'description': 'Assessed by the Addiction Severity Index (ASI) Drug Severity Score, this score reflects the severity of functional impairment due to drug use. Higher scores reflect more interference (worse outcome) and the range of scores is 0-1.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to partial missing data, 2 participants are missing from the RCT ICBT arm and 3 from the RCT IDC arm.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Patient Satisfaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'I-CBT Feasibility Pilot', 'description': 'Open trial of I-CBT\n\nI-CBT: New cognitive behavioral therapy treatment manual developed to treat co-occurring anxiety and opioid dependency disorders.'}, {'id': 'OG001', 'title': 'RCT: I-CBT', 'description': 'Randomized control trial of I-CBT vs ICD\n\nI-CBT: New cognitive behavioral therapy treatment manual developed to treat co-occurring anxiety and opioid dependency disorders.'}, {'id': 'OG002', 'title': 'RCT IDC', 'description': 'Randomized control trial of I-CBT vs ICD\n\nIDC: Individual Drug Counseling manual that has demonstrated efficacy for the treatment of drug dependence.'}], 'classes': [{'categories': [{'measurements': [{'value': '32', 'spread': '0', 'groupId': 'OG000'}, {'value': '26.9', 'spread': '4.8', 'groupId': 'OG001'}, {'value': '29.4', 'spread': '3.2', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 12', 'description': 'Assessed by the Client Satisfaction Questionnaire (CSQ), this measure assesses patient satisfaction with treatment. Higher scores reflect higher satisfaction (better outcome). The scores range from 8-32.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to partial missing data, 2 participants are missing from the RCT ICBT arm and 2 from the RCT IDC arm.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'I-CBT Feasibility Pilot', 'description': 'Open trial of I-CBT\n\nI-CBT: New cognitive behavioral therapy treatment manual developed to treat co-occurring anxiety and opioid dependency disorders.'}, {'id': 'FG001', 'title': 'RCT I-CBT', 'description': 'Randomized controlled trial: Integrated Cognitive-Behavioral Therapy Arm\n\nI-CBT: New cognitive behavioral therapy treatment manual developed to treat co-occurring anxiety and opioid dependency disorders.'}, {'id': 'FG002', 'title': 'RCT IDC', 'description': 'Randomized Controlled Trial: Individual Drug Counseling Arm\n\nIDC: Individual Drug Counseling manual that has demonstrated efficacy for the treatment of drug dependence.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '13'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '13'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'In the randomized controlled trial, 6 participants completed a baseline assessment but dropped out prior to randomization.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '31', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'I-CBT Feasibility Pilot', 'description': 'Open trial of I-CBT\n\nI-CBT: New cognitive behavioral therapy treatment manual developed to treat co-occurring anxiety and opioid dependency disorders.'}, {'id': 'BG001', 'title': 'I-CBT RCT', 'description': 'Randomized control trial of I-CBT vs ICD\n\nI-CBT: New cognitive behavioral therapy treatment manual developed to treat co-occurring anxiety and opioid dependency disorders.'}, {'id': 'BG002', 'title': 'IDC RCT', 'description': 'Randomized control trial of I-CBT vs ICD\n\nIDC: Individual Drug Counseling manual that has demonstrated efficacy for the treatment of drug dependence.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '31.8', 'spread': '8.3', 'groupId': 'BG000'}, {'value': '33.9', 'spread': '10.5', 'groupId': 'BG001'}, {'value': '31.8', 'spread': '9.6', 'groupId': 'BG002'}, {'value': '32.7', 'spread': '9.6', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '30', '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': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', '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': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '31', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', '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': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '31', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-11-30', 'size': 524231, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-09-11T14:18', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 37}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2019-12-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-10', 'studyFirstSubmitDate': '2014-09-25', 'resultsFirstSubmitDate': '2020-09-18', 'studyFirstSubmitQcDate': '2014-09-25', 'lastUpdatePostDateStruct': {'date': '2020-11-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-11-10', 'studyFirstPostDateStruct': {'date': '2014-09-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-11-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Patient Satisfaction', 'timeFrame': 'Week 12', 'description': 'Assessed by the Client Satisfaction Questionnaire (CSQ), this measure assesses patient satisfaction with treatment. Higher scores reflect higher satisfaction (better outcome). The scores range from 8-32.'}], 'primaryOutcomes': [{'measure': 'Urine-confirmed Self-reported Weeks of Opioid Use', 'timeFrame': 'Week 12', 'description': 'Number of weeks of opioid use at Week 12 for the last 4 weeks of treatment (Weeks 9-12), as assessed by self-report and validated by urine drug screen'}, {'measure': 'Anxiety Symptom Severity', 'timeFrame': 'Week 12', 'description': 'Hamilton Anxiety Rating Scale (HADS) score. Measure assesses the severity of anxiety symptoms. Total scale scores are reported. Higher scores reflect worse outcome. The range of possible scores is 0-56.'}], 'secondaryOutcomes': [{'measure': 'Quality of Life - General Health Score', 'timeFrame': 'Week 12', 'description': 'Assessed by the World Health Organization Quality of Life measure, measure reflects overall health as an indicator of quality of life. The scale range of possible scores is 2-10, with higher scores reflected better outcome (i.e., better general health).'}, {'measure': 'Non-opioid Substance Use', 'timeFrame': 'Week 12', 'description': 'Days of other substance use in the past 30 days'}, {'measure': 'Functional Impairment', 'timeFrame': 'Week 12', 'description': 'Assessed by the Addiction Severity Index (ASI) Drug Severity Score, this score reflects the severity of functional impairment due to drug use. Higher scores reflect more interference (worse outcome) and the range of scores is 0-1.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Anxiety Disorders', 'Opiate Addiction']}, 'descriptionModule': {'briefSummary': 'Anxiety is highly prevalent among individuals with opioid dependence and confers greater risk for continued opioid use and poor treatment outcomes. However, there are currently no efficacious treatments available for co-occurring opioid dependence and anxiety. The ultimate aims of this trial are the development and testing of a novel integrated cognitive behavioral treatment (I-CBT) for co-occurring opioid dependence and anxiety disorders. This clinical trial consists of two phases: (1) open-trial pilot (2) randomized control trial. We hypothesize that I-CBT will be a feasible and acceptable treatment that will result in significant reductions in anxiety and opioid use.', 'detailedDescription': 'This Stage 1 behavioral treatment development trial involves two stages: manual development and pilot testing in an open trial, and a small randomized controlled trial. In both phases, opioid use and anxiety symptoms will be measured as the primary clinical outcome, along with measures of feasibility and patient satisfaction. These results will be used to further refine the treatment manual and to evaluate whether this treatment may enhance outcomes for adults with co-occurring opioid dependence and anxiety disorders.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age 18 or older\n* meet current Diagnostic and Statistical Manual of Mental Disorders 5th edition diagnostic criteria for opioid use disorder\n* currently prescribed pharmacotherapy for opioid dependence\n* have used opioids illicitly within the previous 90 days\n* clinically-significant anxiety\n* meet current diagnostic criteria for a Diagnostic and Statistical Manual of Mental Disorders 5th edition anxiety disorder\n* able to read and provide informed consent\n* intend to remain in the geographical area for the duration of the study period\n\nExclusion Criteria:\n\n* meet criteria for a current substance use or psychiatric disorder requiring a level of care higher than outpatient\n* currently receiving cognitive behavioral therapy\n* recent initiation of a psychiatric medication, defined as less than 4 weeks on a stable dose; not including PRN medications for sleep\n* are receiving and taking an as-needed (PRN) prescription for benzodiazepines\n* presence of a psychiatric or medical condition that would interfere with participation or that requires additional care (e.g. psychosis, acute suicidality)\n* were admitted to McLean Hospital for their current treatment episode on an involuntary status'}, 'identificationModule': {'nctId': 'NCT02252068', 'briefTitle': 'Study of Treatment for Opioid Dependence and Anxiety Disorders', 'organization': {'class': 'OTHER', 'fullName': 'Mclean Hospital'}, 'officialTitle': 'Behavioral Treatment Development for Co-occurring Opioid Dependence and Anxiety Disorders', 'orgStudyIdInfo': {'id': 'K23DA035297', 'link': 'https://reporter.nih.gov/quickSearch/K23DA035297', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'I-CBT feasibility pilot', 'description': 'Open trial of I-CBT', 'interventionNames': ['Behavioral: I-CBT']}, {'type': 'EXPERIMENTAL', 'label': 'I-CBT randomized trial', 'description': 'I-CBT in randomized trial.', 'interventionNames': ['Behavioral: I-CBT']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'IDC randomized trial', 'description': 'Comparison condition (Individualized Drug Counseling) in randomized trial.', 'interventionNames': ['Behavioral: IDC']}], 'interventions': [{'name': 'I-CBT', 'type': 'BEHAVIORAL', 'description': 'New cognitive behavioral therapy treatment manual developed to treat co-occurring anxiety and opioid dependency disorders.', 'armGroupLabels': ['I-CBT feasibility pilot', 'I-CBT randomized trial']}, {'name': 'IDC', 'type': 'BEHAVIORAL', 'description': 'Individual Drug Counseling manual that has demonstrated efficacy for the treatment of drug dependence.', 'armGroupLabels': ['IDC randomized trial']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02478', 'city': 'Belmont', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'McLean Hospital', 'geoPoint': {'lat': 42.39593, 'lon': -71.17867}}], 'overallOfficials': [{'name': 'Rebecca K McHugh, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mclean Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mclean Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Psychologist, Division of Alcohol and Drug Abuse', 'investigatorFullName': 'McHugh, R. Kathryn', 'investigatorAffiliation': 'Mclean Hospital'}}}}