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Not yet recruitingNCT07443332Updated Jul 16, 2026

Culturally Adapted Contingency Management

An interventional study of Cultually Adapted Contingency Management (CM) and Basic Contingency Management (CM) in Stimulant Use Disorders, sponsored by Yale University. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-07-16.

Sponsored by Yale University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Stimulant Use Disorders
03

In context

Lead sponsor

Yale University is the lead sponsor of 1,724 studies on the registry; 298 are open to participants now.

Of its 210 completed or terminated interventional studies of FDA-regulated products, 126 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • individuals who are intoxicated or otherwise unable to provide consent
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
70 participants (estimated)

Study arms

  • Experimental
    Culturally Adapted CM

    Participants in this arm will receive the culturally adapted CM over a 12- week treatment period

    Behavioral: Cultually Adapted Contingency Management (CM)

  • Experimental
    Basic CM

    Participants in this arm will receive the basic CM over a 12- week treatment period

    Behavioral: Basic Contingency Management (CM)

  • 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

Interventions

  • 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

06

What researchers measure

Primary outcomes

  1. Percent negative urine samples

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

    Time frame: Week 12

  2. Mean longest duration of abstinence

    The longest duration of abstinence in days will be measured.

    Time frame: Week 12

Secondary outcomes

  1. Mean treatment retention

    Treatment retention in days will be measured.

    Time frame: Baseline and Week 12.

  2. Acceptability of Intervention Measure (AIM)

    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.

    Time frame: Week 12

  3. Feasibility of Intervention Measure (FIM)

    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.

    Time frame: Week 12

  4. Client Satisfaction Questionnaire (CSQ-8)

    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

    Time frame: Week 12

07

Study locations

1 site
  • Connecticut Mental Health Center (CMHC)
    New Haven, Connecticut 06519, United States
08

References and documents

Publications

  • Jegede OO, Becker SJ, Iheanacho T, Bellamy C, Petrakis I, Kiluk B, Rash C. Rationale, design and methods of the Cul-CM study: a protocol for cultural adaptation of contingency management in adults with stimulant use disorder. BMJ Open. 2026 Jul 8;16(7):e120424. doi: 10.1136/bmjopen-2026-120424. PubMed 42419893 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07443332
Lead sponsor
Yale University
Collaborators
National Institute on Drug Abuse (NIDA)
Responsible party
Sponsor
First posted
Mar 2, 2026
Start date
Jul 2028 (estimated)
Primary completion
Mar 2030 (estimated)
Completion
Mar 2030 (estimated)
Last update
Jul 16, 2026

Study contacts

Oluwole Jegede, MD, PhD
Contact
Oluwole.jegede@yale.edu
203-974-7096
Alexander Alario, PhD
Contact
Alexandra.alario@yale.edu
203-903-4603
Oluwole Jegede, MD, PhD
principal investigator · Yale University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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