Culturally Adapted Contingency Management
Cultural Adaptation of Contingency Management for Black Adults With Stimulant Use Disorder
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
The 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.
Aims 1 and 2 are Observational aims not requiring registration that will inform Aim 3.
The focus of this registration is Aim 3.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Oluwole Jegede, MD, PhD
- Phone Number: 203-974-7096
- Email: Oluwole.jegede@yale.edu
Study Contact Backup
- Name: Alexander Alario, PhD
- Phone Number: 203-903-4603
- Email: Alexandra.alario@yale.edu
Study Locations
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Connecticut
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New Haven, Connecticut, United States, 06519
- Connecticut Mental Health Center (CMHC)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- participants must self-identify as Black/African American
- DSM-5 diagnosis of stimulant use disorder in the past month (30 days)
Exclusion Criteria:
- individuals who are intoxicated or otherwise unable to provide consent
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Culturally Adapted CM
Participants in this arm will receive the culturally adapted CM over a 12- week treatment period
|
Same protocol as basic CM with adaptations incorporated.
The adaption will involve the ADAPT-ITT framework and PEN-3 cultural model.
|
|
Experimental: Basic CM
Participants in this arm will receive the basic CM over a 12- week treatment period
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An escalating schedule of reinforcement for submitting stimulant-negative urine at each clinic visit over the course of the 12 weeks
|
|
No Intervention: Standard Care Condition
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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Percent negative urine samples
Time Frame: Week 12
|
Participants will provide urine samples twice weekly.
Percent of negative urines provided will be calculated.
|
Week 12
|
|
Mean longest duration of abstinence
Time Frame: Week 12
|
The longest duration of abstinence in days will be measured.
|
Week 12
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mean treatment retention
Time Frame: Baseline and Week 12.
|
Treatment retention in days will be measured.
|
Baseline and Week 12.
|
|
Acceptability of Intervention Measure (AIM)
Time Frame: Week 12
|
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.
|
Week 12
|
|
Feasibility of Intervention Measure (FIM)
Time Frame: Week 12
|
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.
|
Week 12
|
|
Client Satisfaction Questionnaire (CSQ-8)
Time Frame: Week 12
|
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
|
Week 12
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Oluwole Jegede, MD, PhD, Yale University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2000040284
- 1K23DA063650-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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