Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2025-12-25 @ 10:10 PM
Study NCT ID:
NCT00763958
Status:
COMPLETED
Last Update Posted:
2012-06-04
First Post:
2008-09-29
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Relapse Prevention to Reduce HIV Among Women Prisoners
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002047', 'term': 'Buprenorphine'}], 'ancestors': [{'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010616', 'term': 'Phenanthrenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kcropsey@uab.edu', 'phone': '205-917-3786', 'title': 'Dr. Karen Cropsey', 'phoneExt': '205', 'organization': 'University of Alabama at Birmingham'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Slow recruitment with poor retention. Transient population that was difficult to effectively track.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Buprenorphine', 'description': 'Buprenorphine provided for 12 weeks up to 32 mg daily based on clinical assessment.', 'otherNumAtRisk': 28, 'otherNumAffected': 0, 'seriousNumAtRisk': 28, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Medication "sugar pill" provided for 12 weeks up to 32 mg daily.', 'otherNumAtRisk': 16, 'otherNumAffected': 0, 'seriousNumAtRisk': 16, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Opiate Positive Urines With Missing Urines Coded as Positive at Week 12.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Buprenorphine', 'description': 'Buprenorphine provided for 12 weeks of study drug based on clinical assessment.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Medication "sugar pill" provided for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks', 'description': 'Number of participants with positive opiate urine samples at 12 weeks of treatment.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects were included in the analysis population as intent to treat.', 'anticipatedPostingDate': '2010-02'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Enroll in the Study.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Buprenorphine', 'description': 'Buprenorphine provided for 12 weeks of stuty drug based on clinical assessment.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Medication "sugar pill" provided for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 24 months', 'description': 'To determine the number of participants who enroll in the study during the time of recruitment.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Opiate Positive Urines With Missing Urines Coded as Positive at Week 24.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Buprenorphine', 'description': 'Buprenorphine provided for 12 weeks of study drug based on clinical assessment.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Medication "sugar pill" provided for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '24 weeks', 'description': 'Number of participants with positive opiate urine sample at the 24 week follow-up.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects were included in the analysis population as intent to treat.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Buprenorphine', 'description': 'Buprenorphine provided for 12 weeks up to 32 mg daily based on clinical assessment.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Medication "sugar pill" provided for 12 weeks up to 32 mg daily.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '11'}]}], 'dropWithdraws': [{'type': 'did not meet final criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Believed they were receiving placebo', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '5'}]}]}], 'recruitmentDetails': 'Recruitment began in May of 2008 and ended June of 2010. All participants were recruited from a 28-day drug inpatient facility that accepts patients from the criminal justice system.', 'preAssignmentDetails': 'Initially, 11 women were enrolled in the open-label trial, followed by 33 women randomized to either buprenorphine or placebo.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Buprenorphine', 'description': 'Buprenorphine provided for 12 weeks up to 32 mg daily based on clinical assessment.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Medication "sugar pill" provided for 12 weeks up to 32 mg daily.'}, {'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': '28', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '30.2', 'spread': '6.6', 'groupId': 'BG000'}, {'value': '34.7', 'spread': '10.3', 'groupId': 'BG001'}, {'value': '31.8', 'spread': '8.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-05', 'completionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-05-01', 'studyFirstSubmitDate': '2008-09-29', 'resultsFirstSubmitDate': '2011-02-04', 'studyFirstSubmitQcDate': '2008-09-29', 'lastUpdatePostDateStruct': {'date': '2012-06-04', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-05-01', 'studyFirstPostDateStruct': {'date': '2008-10-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-06-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Opiate Positive Urines With Missing Urines Coded as Positive at Week 12.', 'timeFrame': '12 weeks', 'description': 'Number of participants with positive opiate urine samples at 12 weeks of treatment.'}, {'measure': 'Opiate Positive Urines With Missing Urines Coded as Positive at Week 24.', 'timeFrame': '24 weeks', 'description': 'Number of participants with positive opiate urine sample at the 24 week follow-up.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants Who Enroll in the Study.', 'timeFrame': 'up to 24 months', 'description': 'To determine the number of participants who enroll in the study during the time of recruitment.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['opiates', 'HIV'], 'conditions': ['Opioid Dependence', 'HIV']}, 'descriptionModule': {'briefSummary': 'This study is a feasibility and acceptability study assessing whether providing buprenorphine for women under criminal justice supervision leaving a controlled environment and returning to the community would prevent opioid relapse and reduce HIV risk behaviors.', 'detailedDescription': "This study sought to enroll opioid dependent women under supervision in the criminal justice system and in a controlled environment (substance abuse treatment)but at at high risk for opioid relapse and engaging in HIV risk behaviors when returning to the community. Initially, 9 women were enrolled and received buprenorphine medication. After the first 9 participants, women were randomized to either buprenorphine or placebo. Women received the buprenorphine medication for 12 weeks in the community and at the end of the 12 weeks were transitioned either to another buprenorphine provider, methadone provider, or tapered off buprenorphine based on the participant's preferences. One additional follow-up at 3 months after treatment was conducted. The primary outcome was opioid positive urines at all time points."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* female,\n* history of opioid dependence,\n* released back to the community from a controlled environment,\n* criminal justice involvement.\n\nExclusion Criteria:\n\n* under age 19,\n* medical contraindications,\n* major psychiatric problems.'}, 'identificationModule': {'nctId': 'NCT00763958', 'briefTitle': 'Relapse Prevention to Reduce HIV Among Women Prisoners', 'organization': {'class': 'OTHER', 'fullName': 'University of Alabama at Birmingham'}, 'officialTitle': 'Relapse Prevention to Reduce HIV Among Women Prisoners', 'orgStudyIdInfo': {'id': 'R21DA019838', 'link': 'https://reporter.nih.gov/quickSearch/R21DA019838', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': '5R21DA019838-03', 'link': 'https://reporter.nih.gov/quickSearch/5R21DA019838-03', 'type': 'NIH'}, {'id': '7R21DA019838-02', 'link': 'https://reporter.nih.gov/quickSearch/7R21DA019838-02', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Buprenorphine', 'description': 'Active sublingual buprenorphine provided to participants; dose as clinically indicated up to 32 mg daily for up to 3 months', 'interventionNames': ['Drug: Buprenorphine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo sublingual medication provided to individuals randomized to control up to 3 months', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo to match buprenorphine administered for 3 months', 'armGroupLabels': ['Placebo']}, {'name': 'Buprenorphine', 'type': 'DRUG', 'description': 'Buprenorphine provided for 3 months; dosing was as clinically indicated up to 32 mg daily.', 'armGroupLabels': ['Buprenorphine']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alabama at Birmingham', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Karen Cropsey', 'investigatorAffiliation': 'University of Alabama at Birmingham'}}}}