Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-31 @ 9:54 AM
Study NCT ID:
NCT07443332
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-02
First Post:
2026-02-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Culturally Adapted Contingency Management
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants are adults with stimulant use disorder who identify as Black/African American.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2030-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-24', 'studyFirstSubmitDate': '2026-02-24', 'studyFirstSubmitQcDate': '2026-02-24', 'lastUpdatePostDateStruct': {'date': '2026-03-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent negative urine samples', 'timeFrame': 'Week 12', 'description': 'Participants will provide urine samples twice weekly. Percent of negative urines provided will be calculated.'}, {'measure': 'Mean longest duration of abstinence', 'timeFrame': 'Week 12', 'description': 'The longest duration of abstinence in days will be measured.'}], 'secondaryOutcomes': [{'measure': 'Mean treatment retention', 'timeFrame': 'Baseline and Week 12.', 'description': 'Treatment retention in days will be measured.'}, {'measure': 'Acceptability of Intervention Measure (AIM)', 'timeFrame': 'Week 12', 'description': 'Treatment Acceptability will be measured using the Acceptability of Intervention Measure (AIM), a 4-item measure of perceived intervention acceptability.Total score 1-5 with higher scores indicating greater acceptability.'}, {'measure': 'Feasibility of Intervention Measure (FIM)', 'timeFrame': 'Week 12', 'description': 'Feasibility of intervention measured using Feasibility of Intervention Measure (FIM)- a 4-item instrument to assess perceived intervention feasibility. Total score 1-5 with higher scores indicating greater feasibility.'}, {'measure': 'Client Satisfaction Questionnaire (CSQ-8)', 'timeFrame': 'Week 12', 'description': "An 8-item, self-report measure developed to assess global satisfaction with health and behavioral health services. Each item is rated on a 4-point Likert scale, producing total scores ranging from 8 to 32, with higher scores indicating greater satisfaction. The instrument evaluates perceived quality of care, extent to which services met the client's needs, overall benefit, and willingness to recommend the service"}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stimulant Use Disorders']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to develop a culturally adapted contingency management (CM) protocol for Black adults with stimulant use disorder.', 'detailedDescription': "This project seeks to develop a culturally adapted Contingency Management (CM) intervention for Black adults with stimulant use disorder (StUD). CM is grounded in behavioral economics and involves the use of tangible positive reinforcements to incentivize verifiable pro-health behaviors. There has been a recent surge in fatal stimulant related drug overdoses in the Black community. Black adults in the United States have been experiencing faster rates of overdose deaths, with a rate of 49.5/100,000 in 2022 (1.4 times the rate among White Americans). A resurgence in stimulant use, contamination of community drug supplies with high potency synthetic opioids (HPSO) and a range of structural and social vulnerabilities are major drivers of this unfortunate trend. CM has been shown to be the most effective intervention for StUD as there are no FDA approved medications for this indication. Emerging evidence shows that Black adults who entered treatment with cocaine-positive urines did not show any gains in treatment retention or other clinical outcomes. This observation of disparate health outcomes has informed the urgency to culturally adapt CM for Black population which is at heightened risk given the opioids/stimulant polysubstance fatal overdose.\n\nThe objective of this research is to develop components of a culturally adapted CM using theoretically and empirically driven approaches. Specific research aims include: 1) Assessment of the target population's behavioral risks, perceived need for prevention, barriers, preferences for intervention and development of components of CM adaptation; 2) production of iterative drafts of the adapted CM and 3.) Pilot randomized controlled trial to examine the short-term efficacy of the adapted CM with the primary outcomes of percent negative urines and longest duration of abstinence during treatment. Aim 3 consists of PI training to deliver the culturally adapted treatment and the culturally adapted treatment will be piloted with the community that the treatment was adapted for over 12 weeks, twice weekly, with a 4 week lead-in phase.\n\nAims 1 and 2 are Observational aims not requiring registration that will inform Aim 3.\n\nThe focus of this registration is Aim 3."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* participants must self-identify as Black/African American\n* DSM-5 diagnosis of stimulant use disorder in the past month (30 days)\n\nExclusion Criteria:\n\n* individuals who are intoxicated or otherwise unable to provide consent'}, 'identificationModule': {'nctId': 'NCT07443332', 'briefTitle': 'Culturally Adapted Contingency Management', 'organization': {'class': 'OTHER', 'fullName': 'Yale University'}, 'officialTitle': 'Cultural Adaptation of Contingency Management for Black Adults With Stimulant Use Disorder', 'orgStudyIdInfo': {'id': '2000040284'}, 'secondaryIdInfos': [{'id': '1K23DA063650-01', 'link': 'https://reporter.nih.gov/quickSearch/1K23DA063650-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Culturally Adapted CM', 'description': 'Participants in this arm will receive the culturally adapted CM over a 12- week treatment period', 'interventionNames': ['Behavioral: Cultually Adapted Contingency Management (CM)']}, {'type': 'EXPERIMENTAL', 'label': 'Basic CM', 'description': 'Participants in this arm will receive the basic CM over a 12- week treatment period', 'interventionNames': ['Behavioral: Basic Contingency Management (CM)']}, {'type': 'NO_INTERVENTION', 'label': 'Standard Care Condition', 'description': 'Intensive Outpatient clinic (IOP) at substance use treatment and addiction (SATU) clinic twice every week, one day for group and the other for individual counseling'}], 'interventions': [{'name': 'Cultually Adapted Contingency Management (CM)', 'type': 'BEHAVIORAL', 'description': 'Same protocol as basic CM with adaptations incorporated. The adaption will involve the ADAPT-ITT framework and PEN-3 cultural model.', 'armGroupLabels': ['Culturally Adapted CM']}, {'name': 'Basic Contingency Management (CM)', 'type': 'BEHAVIORAL', 'description': 'An escalating schedule of reinforcement for submitting stimulant-negative urine at each clinic visit over the course of the 12 weeks', 'armGroupLabels': ['Basic CM']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06519', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Connecticut Mental Health Center (CMHC)', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}], 'centralContacts': [{'name': 'Oluwole Jegede, MD, PhD', 'role': 'CONTACT', 'email': 'Oluwole.jegede@yale.edu', 'phone': '203-974-7096'}, {'name': 'Alexander Alario, PhD', 'role': 'CONTACT', 'email': 'Alexandra.alario@yale.edu', 'phone': '203-903-4603'}], 'overallOfficials': [{'name': 'Oluwole Jegede, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yale University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yale University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}