NCT07443332

Brief Summary

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

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
47mo left

Started Mar 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress5%
Mar 2026Mar 2030

First Submitted

Initial submission to the registry

February 24, 2026

Completed
5 days until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 2, 2026

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2030

Last Updated

March 2, 2026

Status Verified

February 1, 2026

Enrollment Period

4 years

First QC Date

February 24, 2026

Last Update Submit

February 24, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Percent negative urine samples

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

    Week 12

  • Mean longest duration of abstinence

    The longest duration of abstinence in days will be measured.

    Week 12

Secondary Outcomes (4)

  • Mean treatment retention

    Baseline and Week 12.

  • Acceptability of Intervention Measure (AIM)

    Week 12

  • Feasibility of Intervention Measure (FIM)

    Week 12

  • Client Satisfaction Questionnaire (CSQ-8)

    Week 12

Study Arms (3)

Culturally Adapted CM

EXPERIMENTAL

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

Behavioral: Cultually Adapted Contingency Management (CM)

Basic CM

EXPERIMENTAL

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

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

Interventions

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

Culturally Adapted CM

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

Basic CM

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • participants must self-identify as Black/African American
  • DSM-5 diagnosis of stimulant use disorder in the past month (30 days)

You may not qualify if:

  • individuals who are intoxicated or otherwise unable to provide consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Connecticut Mental Health Center (CMHC)

New Haven, Connecticut, 06519, United States

Location

Study Officials

  • Oluwole Jegede, MD, PhD

    Yale University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Oluwole Jegede, MD, PhD

CONTACT

Alexander Alario, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Participants are adults with stimulant use disorder who identify as Black/African American.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 24, 2026

First Posted

March 2, 2026

Study Start

March 1, 2026

Primary Completion (Estimated)

March 1, 2030

Study Completion (Estimated)

March 1, 2030

Last Updated

March 2, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations