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Not Yet RecruitingNCT07443332

Culturally Adapted Contingency Management

Cultural Adaptation of Contingency Management for Black Adults With Stimulant Use Disorder

Status
Not Yet Recruiting
Phase
N/A
Study type
Interventional
Enrollment
70 (estimated)
Sponsor
Yale University · Academic / Other
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Not accepted

Summary

The purpose of this study is to develop a culturally adapted contingency management (CM) protocol for Black adults with stimulant use disorder.

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALCultually Adapted Contingency Management (CM)Same protocol as basic CM with adaptations incorporated. The adaption will involve the ADAPT-ITT framework and PEN-3 cultural model.
BEHAVIORALBasic Contingency Management (CM)An escalating schedule of reinforcement for submitting stimulant-negative urine at each clinic visit over the course of the 12 weeks

Timeline

Start date
2026-03-01
Primary completion
2030-03-01
Completion
2030-03-01
First posted
2026-03-02
Last updated
2026-03-02

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT07443332. Inclusion in this directory is not an endorsement.