Stimulant Use DisordersNCT07443332
Culturally Adapted Contingency Management
A study testing Cultually Adapted Contingency Management (CM) and Basic Contingency Management (CM) in people with Stimulant Use Disorders, run by Yale University at 1 site in United States.
Trial summary
The purpose of this study is to develop a culturally adapted contingency management (CM) protocol for Black adults with stimulant use disorder. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Stimulant Use Disorders
- What is being tested?
- Cultually Adapted Contingency Management (CM) and Basic Contingency Management (CM)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2028to Mar 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- participants must self-identify as Black/African American
- DSM-5 diagnosis of stimulant use disorder in the past month (30 days)
Who cannot join
- individuals who are intoxicated or otherwise unable to provide consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Connecticut Mental Health Center (CMHC)
New Haven, Connecticut, 06519
About this study
Official title: Cultural Adaptation of Contingency Management for Black Adults With Stimulant Use Disorder
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.
- Conditions
- Stimulant Use Disorders
- Being tested
- Cultually Adapted Contingency Management (CM), Basic Contingency Management (CM)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cultually Adapted Contingency Management (CM)Behavioural
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)Behavioural
An escalating schedule of reinforcement for submitting stimulant-negative urine at each clinic visit over the course of the 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Culturally Adapted CM | Experimental | Participants in this arm will receive the culturally adapted CM over a 12- week treatment period Receives: Behavioral: Cultually Adapted Contingency Management (CM) |
| Basic CM | Experimental | Participants in this arm will receive the basic CM over a 12- week treatment period Receives: Behavioral: Basic Contingency Management (CM) |
| Standard Care Condition | No intervention | 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent negative urine samples
Participants will provide urine samples twice weekly. Percent of negative urines provided will be calculated.
Measured: Week 12
Mean longest duration of abstinence
The longest duration of abstinence in days will be measured.
Measured: Week 12
Secondary outcomes (4)
Mean treatment retention
Treatment retention in days will be measured.
Measured: Baseline and Week 12.
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.
Measured: Week 12
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.
Measured: Week 12
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
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2026
- Study startJul 2028 (estimated)
- Primary completionMar 2030 (estimated)
- Study completionMar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stimulant Use DisordersStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are adults with stimulant use disorder who identify as Black/African American.
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Oluwole Jegede, MD, PhD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07443332
- Sponsor's protocol ID
- 2000040284
- Other IDs
- 1K23DA063650-01
- Status last verified
- Jul 2026
- First submitted
- 24 Feb 2026
- Last updated
- 16 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cultural Adaptation of Contingency Management for Black Adults With Stimulant Use Disorder
- ClinicalTrials.gov ID
- NCT07443332
- Acronym / sponsor ID
- 2000040284
- Conditions
- Stimulant Use Disorders
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Jul 2028 (estimated)
- Primary completion
- Mar 2030 (estimated)
- Study completion
- Mar 2030 (estimated)
- First posted
- 2 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Participants are adults with stimulant use disorder who identify as Black/African American.
| Arm | Type | Receives |
|---|---|---|
| Culturally Adapted CM | Experimental | Behavioral: Cultually Adapted Contingency Management (CM)Participants in this arm will receive the culturally adapted CM over a 12- week treatment period |
| Basic CM | Experimental | Behavioral: Basic Contingency Management (CM)Participants in this arm will receive the basic CM over a 12- week treatment period |
| Standard Care Condition | No intervention | –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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- participants must self-identify as Black/African American
- DSM-5 diagnosis of stimulant use disorder in the past month (30 days)
Key exclusion criteria (1 listed)
- individuals who are intoxicated or otherwise unable to provide consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cultually 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. | Behavioural | Culturally Adapted CM |
| Basic Contingency Management (CM)An escalating schedule of reinforcement for submitting stimulant-negative urine at each clinic visit over the course of the 12 weeks | Behavioural | Basic CM |
Primary outcome
Percent negative urine samples
Time frame: Week 12
Participants will provide urine samples twice weekly. Percent of negative urines provided will be calculated.
Mean longest duration of abstinence
Time frame: Week 12
The longest duration of abstinence in days will be measured.
4 secondary outcomes
Mean treatment retention
Time frame: Baseline and Week 12.
Acceptability of Intervention Measure (AIM)
Time frame: Week 12
Feasibility of Intervention Measure (FIM)
Time frame: Week 12
Client Satisfaction Questionnaire (CSQ-8)
Time frame: Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Derived from this study: PubMed 42419893Jegede 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.
- Individual participant dataSharing planned: No
Related trials for Stimulant Use Disorders
Recruiting
Rural Community Peer Partnerships for Improving Methamphetamine-Associated Heart Failure Screening and Engagement
Methamphetamine Use, Heart Failure
Enrolling by invitation
PATH to Reducing Burnout Among Peers Who Deliver Overdose Prevention Services (R33 Phase Clinical Trial)
Burnout, Secondary Trauma
Not yet recruiting
Remote Intervention to Prevent Overdose
Accidental Overdose of Opiate
Not yet recruitingPhase 3
Recovery Management Checkup Scalability and Sustainability Hybrid Experiment
Substance Use Disorder (SUD), Opioid Use Disorders
Not yet recruiting
Transcranial Magnetic Stimulation for Methamphetamine Use Disorder During Pregnancy
Methamphetamine Use Disorder, Pregnancy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Oluwole Jegede, MD, PhD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cultually Adapted Contingency Management (CM) and Basic Contingency Management (CM) in people with Stimulant Use Disorders, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Oluwole Jegede, MD, PhD (203-974-7096, Oluwole.jegede@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent negative urine samples (time frame: Week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07443332, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.