Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-31 @ 9:54 AM
Study NCT ID:
NCT07443332
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-02
First Post:
2026-02-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Culturally Adapted Contingency Management
Sponsor:
Yale University
Organization:
Study Overview
Official Title:
Cultural Adaptation of Contingency Management for Black Adults With Stimulant Use Disorder
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 1K23DA063650-01 | NIH | None | https://reporter.nih.gov/quic… | View |