Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2026-01-07 @ 4:05 AM
Study NCT ID:
NCT03345394
Status:
COMPLETED
Last Update Posted:
2021-04-08
First Post:
2017-11-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effectiveness of Contingency Management in the Treatment of Crack Addiction in Brazil
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D019970', 'term': 'Cocaine-Related Disorders'}], 'ancestors': [{'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'aqcmiguel@gmail.com', 'phone': '+55 11 965884111', 'title': 'Dr. André Miguel', 'organization': 'Federal University of Sao Paulo'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '12 weeks', 'description': 'Because this study did not include a pharmacological intervention, the only adverse event information collected was mortality.', 'eventGroups': [{'id': 'EG000', 'title': 'Standard Treatment', 'description': '12 weeks of standard treatment offered by Unidade Recomeço Helvétia treatment program\n\nStandard treatment: Participants will receive the standard treatment offered at Unidade Recomeço Helvétia treatment program', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 48, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Contingency Management', 'description': '12 weeks of standard treatment offered at Unidade Recomeço Helvétia treatment program associated with Contingency Management\n\nContingency Management: Participants will receive vouchers with monetary value for submitting crack cocaine negative urine samples', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 50, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Pattern of Crack Cocaine Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Treatment', 'description': '12 weeks of standard treatment offered by Unidade Recomeço Helvétia treatment program\n\nStandard treatment: Participants will receive the standard treatment offered at Unidade Recomeço Helvétia treatment program'}, {'id': 'OG001', 'title': 'Contingency Management', 'description': '12 weeks of standard treatment offered at Unidade Recomeço Helvétia treatment program associated with Contingency Management\n\nContingency Management: Participants will receive vouchers with monetary value for submitting crack cocaine negative urine samples'}], 'classes': [{'categories': [{'measurements': [{'value': '14.3', 'spread': '4.6', 'groupId': 'OG000'}, {'value': '40.7', 'spread': '5.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'Percentage of negative crack cocaine urine samples submitted during the 12 weeks of treatment', 'unitOfMeasure': 'percent of negative cocaine samples', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'all enrolled participants were analyzed (intention to treat)'}, {'type': 'PRIMARY', 'title': 'Promotion of Continuous Crack Cocaine Abstinence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Treatment', 'description': '12 weeks of standard treatment offered by Unidade Recomeço Helvétia treatment program\n\nStandard treatment: Participants will receive the standard treatment offered at Unidade Recomeço Helvétia treatment program'}, {'id': 'OG001', 'title': 'Contingency Management', 'description': '12 weeks of standard treatment offered at Unidade Recomeço Helvétia treatment program associated with Contingency Management\n\nContingency Management: Participants will receive vouchers with monetary value for submitting crack cocaine negative urine samples'}], 'classes': [{'categories': [{'measurements': [{'value': '1.5', 'spread': '3.4', 'groupId': 'OG000'}, {'value': '4.35', 'spread': '4.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'Longest duration of continuous abstinence achieved (in weeks)', 'unitOfMeasure': 'weeks', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'all participants enrolled in the study were analyzed (intention to treat)'}, {'type': 'SECONDARY', 'title': 'Treatment Retention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Treatment', 'description': '12 weeks of standard treatment offered by Unidade Recomeço Helvétia treatment program\n\nStandard treatment: Participants will receive the standard treatment offered at Unidade Recomeço Helvétia treatment program'}, {'id': 'OG001', 'title': 'Contingency Management', 'description': '12 weeks of standard treatment offered at Unidade Recomeço Helvétia treatment program associated with Contingency Management\n\nContingency Management: Participants will receive vouchers with monetary value for submitting crack cocaine negative urine samples'}], 'classes': [{'categories': [{'measurements': [{'value': '3.4', 'spread': '4.8', 'groupId': 'OG000'}, {'value': '7', 'spread': '5.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'time elapsed between treatment entry and last time present in treatment (in weeks)', 'unitOfMeasure': 'weeks', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'all participants enrolled in the study where analyzed (intention to treat)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Standard Treatment', 'description': '12 weeks of standard treatment offered by Unidade Recomeço Helvétia treatment program\n\nStandard treatment: Participants will receive the standard treatment offered at Unidade Recomeço Helvétia treatment program'}, {'id': 'FG001', 'title': 'Contingency Management', 'description': '12 weeks of standard treatment offered at Unidade Recomeço Helvétia treatment program associated with Contingency Management\n\nContingency Management: Participants will receive vouchers with monetary value for submitting crack cocaine negative urine samples'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '48'}, {'groupId': 'FG001', 'numSubjects': '50'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '48'}, {'groupId': 'FG001', 'numSubjects': '50'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '98', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Standard Treatment', 'description': '12 weeks of standard treatment offered by Unidade Recomeço Helvétia treatment program\n\nStandard treatment: Participants will receive the standard treatment offered at Unidade Recomeço Helvétia treatment program'}, {'id': 'BG001', 'title': 'Contingency Management', 'description': '12 weeks of standard treatment offered at Unidade Recomeço Helvétia treatment program associated with Contingency Management\n\nContingency Management: Participants will receive vouchers with monetary value for submitting crack cocaine negative urine samples'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '40.2', 'spread': '9.2', 'groupId': 'BG000'}, {'value': '37.2', 'spread': '9', 'groupId': 'BG001'}, {'value': '38.7', 'spread': '9.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}]}]}], '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'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', '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': 'Region of Enrollment', 'classes': [{'title': 'Brazil', 'categories': [{'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '98', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Negative urine exam at baseline', 'classes': [{'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'all participants enrolled in the study were analyzed (intention to treat)'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-01-05', 'size': 113238, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-02-05T14:42', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR'], 'maskingDescription': 'researchers had no contact with participants during the 12 week trial'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Single-blind randomized controlled trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 98}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2020-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-16', 'studyFirstSubmitDate': '2017-11-14', 'resultsFirstSubmitDate': '2021-01-07', 'studyFirstSubmitQcDate': '2017-11-16', 'lastUpdatePostDateStruct': {'date': '2021-04-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-03-16', 'studyFirstPostDateStruct': {'date': '2017-11-17', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-04-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pattern of Crack Cocaine Use', 'timeFrame': '12 weeks', 'description': 'Percentage of negative crack cocaine urine samples submitted during the 12 weeks of treatment'}, {'measure': 'Promotion of Continuous Crack Cocaine Abstinence', 'timeFrame': '12 weeks', 'description': 'Longest duration of continuous abstinence achieved (in weeks)'}], 'secondaryOutcomes': [{'measure': 'Treatment Retention', 'timeFrame': '12 weeks', 'description': 'time elapsed between treatment entry and last time present in treatment (in weeks)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['crack cocaine', 'contingency management', 'ambulatory treatment', 'Brazil'], 'conditions': ['Substance Use Disorders', 'Contingency Management', 'Addiction, Cocaine']}, 'descriptionModule': {'briefSummary': 'Crack addiction has become a severe public health problem in Brazil. Crack users present elevated prevalence rates of psychiatric comorbidities, sexual transmitted infections and unemployment with high probability of living or have lived in the streets, history of incarceration and engagement in illegal activities. For the last 20 years a treatment called Contingency Management (CM) have achieved the best results regarding reduction of substance use, promotion of abstinence, treatment attendance and retention in treatment. The first CM study conducted in Brazil advocates for the efficacy of CM on all of these outcomes, suggesting that CM can be effective in a Brazilian population of crack users.', 'detailedDescription': 'The objective of this study is to evaluate the effectiveness of Contingency Management (CM) for crack users living in the "Crackland" region. To achieve this goal, regular treatment staff from Unidade Recomeço Helvétia treatment service will be capacitated in CM to latter-on apply the CM intervention in their respective services. The design will be a single-blind randomized clinical trial composed of a sample of 100 subjects with current diagnose for crack/cocaine dependence. Participants allocated to the control condition will receive 12 weeks of the usual care treatment provided by these two treatment facilities. Participants allocated to the experimental condition will receive the exact same treatment as control participants associated with CM. CM procedure will occur 2 timer per week (every Monday and Thursday or Tuesday and Friday). Primary outcomes are: (1)retention in treatment; (2) reduction of crack use; (3) promotion of continuous crack cocaine abstinence. Secondary findings are reduction on psychiatric symptomatology. The investigator hypothesis is that participants in the CM condition will have a better treatment response in all studied outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* DSM-V diagnose for crack cocaine use disorder\n\nExclusion Criteria:\n\n* being under 18 years old'}, 'identificationModule': {'nctId': 'NCT03345394', 'briefTitle': 'Effectiveness of Contingency Management in the Treatment of Crack Addiction in Brazil', 'organization': {'class': 'OTHER', 'fullName': 'Federal University of São Paulo'}, 'officialTitle': 'Effectiveness of Contingency Management in the Treatment of Crack Addiction for Individuals Living in the "Crackland" Region. A Single-blind Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'FAPESP 2017/05371-8'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Treatment', 'description': '12 weeks of standard treatment offered by Unidade Recomeço Helvétia treatment program', 'interventionNames': ['Behavioral: Standard treatment']}, {'type': 'EXPERIMENTAL', 'label': 'Contingency Management', 'description': '12 weeks of standard treatment offered at Unidade Recomeço Helvétia treatment program associated with Contingency Management', 'interventionNames': ['Behavioral: Contingency Management']}], 'interventions': [{'name': 'Contingency Management', 'type': 'BEHAVIORAL', 'description': 'Participants will receive vouchers with monetary value for submitting crack cocaine negative urine samples', 'armGroupLabels': ['Contingency Management']}, {'name': 'Standard treatment', 'type': 'BEHAVIORAL', 'description': 'Participants will receive the standard treatment offered at Unidade Recomeço Helvétia treatment program', 'armGroupLabels': ['Standard Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01215-010', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Unidade Recomeço Helvétia', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'Andre M de Queiroz Constantino Miguel, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Federal University of São Paulo'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federal University of São Paulo', 'class': 'OTHER'}, 'collaborators': [{'name': 'Washington State University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'André de Queiroz Constantino Miguel', 'investigatorAffiliation': 'Federal University of São Paulo'}}}}