Ignite Creation Date:
2025-12-24 @ 4:46 PM
Ignite Modification Date:
2025-12-28 @ 5:05 PM
Study NCT ID:
NCT01096550
Status:
COMPLETED
Last Update Posted:
2020-04-08
First Post:
2010-03-30
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Intensive Outpatient Versus Outpatient Treatment With Buprenorphine Among African Americans
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D009293', 'term': 'Opioid-Related Disorders'}], 'ancestors': [{'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D000079524', 'term': 'Narcotic-Related Disorders'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'smitchell@friendsresearch.org', 'phone': '410-837-3977', 'title': 'Dr. Shannon Gwin Mitchell', 'phoneExt': '238', 'organization': 'Friends Research Institute'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'OP condition participants received more counseling services at the clinics as part of their regular care than was initially expected and IOP condition participants received slightly less that 9 hours of counseling, on average.'}}, 'adverseEventsModule': {'description': 'serious and/or other \\[non-serious\\] adverse events were not collected/assessed', 'eventGroups': [{'id': 'EG000', 'title': 'Intensive Outpatient', 'description': 'Buprenorphine patients receiving 9 or more hours of outpatient counseling.\n\nIntensive Outpatient : Buprenorphine patients receiving 9 or more hours of outpatient counseling.', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Outpatient', 'description': 'Buprenorphine patients receiving between 2 and 8 hours of outpatient counseling.\n\nOutpatient : Buprenorphine patients receiving 2 to 8 hours of outpatient counseling.', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants Meeting Diagnosis of Opioid Dependence on Composite International Diagnostic Interview-2 (CIDI-2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '145', 'groupId': 'OG000'}, {'value': '155', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intensive Outpatient', 'description': 'Buprenorphine patients receiving 9 or more hours of outpatient counseling.\n\nIntensive Outpatient : Buprenorphine patients receiving 9 or more hours of outpatient counseling.'}, {'id': 'OG001', 'title': 'Outpatient', 'description': 'Buprenorphine patients receiving between 2 and 8 hours of outpatient counseling.\n\nOutpatient : Buprenorphine patients receiving 2 to 8 hours of outpatient counseling.'}], 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months post-baseline', 'unitOfMeasure': 'percentage of opioid dependent subjects', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Intensive Outpatient', 'description': 'Buprenorphine patients receiving 9 or more hours of outpatient counseling.\n\nIntensive Outpatient : Buprenorphine patients receiving 9 or more hours of outpatient counseling.'}, {'id': 'FG001', 'title': 'Outpatient', 'description': 'Buprenorphine patients receiving between 2 and 8 hours of outpatient counseling.\n\nOutpatient : Buprenorphine patients receiving 2 to 8 hours of outpatient counseling.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '170'}, {'groupId': 'FG001', 'numSubjects': '175'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '133'}, {'groupId': 'FG001', 'numSubjects': '146'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '37'}, {'groupId': 'FG001', 'numSubjects': '29'}]}], 'dropWithdraws': [{'type': 'discontinued site', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'non-regular treatment track at clinic', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'clinic readmission', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'non-African American participant', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '9'}]}]}], 'recruitmentDetails': 'New patients entering buprenorphine treatment at one of the two participating outpatient "drug-free" treatment programs were block randomized to either intensive outpatient treatment (IOP) or standard outpatient treatment (OP). The study initially included a third clinic site, which was dropped due to insufficient enrollment at that site.', 'preAssignmentDetails': '345 patients were randomized. Of those, the following participants were excluded from the study shortly after random assignment: 21 were from the discontinued site, 2 were dropped because of non-standard clinic treatment track, 1 voluntarily withdrew, 2 were erroneously re-enrolled. We also excluded 19 non-African Americans, per study protocol.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '170', 'groupId': 'BG000'}, {'value': '175', 'groupId': 'BG001'}, {'value': '345', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Intensive Outpatient', 'description': 'Buprenorphine patients receiving 9 or more hours of outpatient counseling.\n\nIntensive Outpatient : Buprenorphine patients receiving 9 or more hours of outpatient counseling.'}, {'id': 'BG001', 'title': 'Outpatient', 'description': 'Buprenorphine patients receiving between 2 and 8 hours of outpatient counseling.\n\nOutpatient : Buprenorphine patients receiving 2 to 8 hours of outpatient counseling.'}, {'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': '168', 'groupId': 'BG000'}, {'value': '174', 'groupId': 'BG001'}, {'value': '342', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '44.15', 'spread': '8.15', 'groupId': 'BG000'}, {'value': '46.27', 'spread': '6.75', 'groupId': 'BG001'}, {'value': '45.23', 'spread': '7.53', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '129', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '108', 'groupId': 'BG000'}, {'value': '108', 'groupId': 'BG001'}, {'value': '216', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '170', 'groupId': 'BG000'}, {'value': '175', 'groupId': 'BG001'}, {'value': '345', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': '21 were from the discontinued site, 2 dropped because participant was non-regular treatment track, 1 voluntarily withdrew from the study, 1 was erroneously re-enrolled after being re-admitted to the same clinic, and 1 was erroneously re-enrolled, and 19 were not African American.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 319}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-31', 'studyFirstSubmitDate': '2010-03-30', 'resultsFirstSubmitDate': '2013-08-13', 'studyFirstSubmitQcDate': '2010-03-30', 'lastUpdatePostDateStruct': {'date': '2020-04-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2013-08-13', 'studyFirstPostDateStruct': {'date': '2010-03-31', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-10-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Meeting Diagnosis of Opioid Dependence on Composite International Diagnostic Interview-2 (CIDI-2)', 'timeFrame': '6 months post-baseline'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['opioid dependence', 'outpatient treatment', 'intensive outpatient treatment'], 'conditions': ['Drug Dependence']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the effectiveness of different levels of counseling (intensive outpatient versus standard outpatient) on treatment outcomes for African American adult patients receiving buprenorphine in 2 formerly "drug-free" programs.', 'detailedDescription': 'This two-group randomized clinical trial will test the effectiveness of intensive outpatient (IOP) v. standard outpatient (OP) treatment in 272 heroin-dependent African American adults receiving buprenorphine in 2 formerly "drug-free" programs. Participants will be randomly assigned to one of the two treatment intensity conditions at intake and assessed at baseline, 3-, and 6-months post-baseline to determine treatment retention, frequency and severity of heroin and cocaine use, self-reported HIV-risk, quality of life, and to determine DSM-IV criteria for Full or Partial Remission of Opioid Dependence. Furthermore, patient factors potentially critical for treatment success (e.g., attitudes towards buprenorphine and average buprenorphine dose while in treatment) will be examined to determine their importance in influencing treatment outcomes. Moreover, both patient and staff attitudes and average buprenorphine dose will be evaluated to determine their respective relationships to treatment experiences and treatment retention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* heroin-dependent adults\n* new admissions to buprenorphine outpatient treatment\n\nExclusion Criteria:\n\n* pregnancy\n* acute medical or psychiatric illness'}, 'identificationModule': {'nctId': 'NCT01096550', 'briefTitle': 'Intensive Outpatient Versus Outpatient Treatment With Buprenorphine Among African Americans', 'organization': {'class': 'OTHER', 'fullName': 'Friends Research Institute, Inc.'}, 'officialTitle': 'Intensive Outpatient v. Outpatient Treatment With Buprenorphine Among African Americans', 'orgStudyIdInfo': {'id': '1RC1DA028407-01', 'link': 'https://reporter.nih.gov/quickSearch/1RC1DA028407-01', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': '1RC1DA028407-01', 'link': 'https://reporter.nih.gov/quickSearch/1RC1DA028407-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intensive Outpatient', 'description': 'Buprenorphine patients receiving 9 or more hours of outpatient counseling.', 'interventionNames': ['Behavioral: Intensive Outpatient']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Outpatient', 'description': 'Buprenorphine patients receiving between 2 and 8 hours of outpatient counseling.', 'interventionNames': ['Behavioral: Outpatient']}], 'interventions': [{'name': 'Outpatient', 'type': 'BEHAVIORAL', 'description': 'Buprenorphine patients receiving 2 to 8 hours of outpatient counseling.', 'armGroupLabels': ['Outpatient']}, {'name': 'Intensive Outpatient', 'type': 'BEHAVIORAL', 'description': 'Buprenorphine patients receiving 9 or more hours of outpatient counseling.', 'armGroupLabels': ['Intensive Outpatient']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Friends Research Institute', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Shannon G Mitchell, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Friends Research Institute, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Friends Research Institute, Inc.', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}