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NCT Number: NCT07443332

Culturally Adapted Contingency Management

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

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Key information

Conditions

Stimulant Use Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Connecticut Mental Health Center (CMHC)

New Haven, Connecticut, 06519, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cultually Adapted Contingency Management (CM)

Behavioral

Same protocol as basic CM with adaptations incorporated. The adaption will involve the ADAPT-ITT framework and PEN-3 cultural model.

Basic Contingency Management (CM)

Behavioral

An escalating schedule of reinforcement for submitting stimulant-negative urine at each clinic visit over the course of the 12 weeks

Primary outcomes

  1. Percent negative urine samples

    Time frame: Week 12

    Participants will provide urine samples twice weekly. Percent of negative urines provided will be calculated.

  2. Mean longest duration of abstinence

    Time frame: Week 12

    The longest duration of abstinence in days will be measured.

Secondary outcomes

  1. Mean treatment retention

    Time frame: Baseline and Week 12.

    Treatment retention in days will be measured.

  2. 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.

  3. 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.

  4. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Alexander Alario, PhD

CONTACT

[email protected]

203-903-4603

Oluwole Jegede, MD, PhD

CONTACT

[email protected]

203-974-7096

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

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

Important dates

Study start
2028
Primary completion
2030
Study completion
2030
First posted
Mar 2, 2026
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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