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Community Driven Substance Use Recovery for High Opioid Overdose Areas

Community Driven Substance Use Recovery for High Opioid Overdose Areas

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05260047
Acronym
IMANI U
Enrollment
525
Registered
2022-03-02
Start date
2022-07-20
Completion date
2026-10-01
Last updated
2026-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Medication Assisted Treatment, Mental Health Issue, Opioid Use, Substance Use

Brief summary

The main goal of this current study is to develop and optimize methods for increasing access to, uptake of, and engagement in MAT (Medication Assisted Treatment) among communities of color.

Detailed description

The main goal of this current study is to develop and optimize methods for increasing access to, uptake of, and engagement in MAT (Medication Assisted Treatment) among communities in geographical areas with high overdose cases. Through a multilevel Community Based Participatory Research initiative and a rigorous RCT that incorporates elements of choice in participation, the study will examine whether adding a church-based telehealth MAT option to Imani (Imani + CTM) will improve outcomes for people who reside in geographical areas with high overdose rates with Alcohol Use Disorder or Opioid Use Disorder)compared to Imani + Traditional MAT Referral and Linkage (Imani + Traditional MAT R&L) in the community. Individuals who do not choose to engage in MAT will continue in the Imani group program as usual. Imani (meaning Faith in Swahili) Breakthrough was developed in 2017 through a community based participatory research process. Imani Breakthrough is a faith-based, person-centered, culturally informed harm reduction recovery program that takes place churches in the community in geographical areas with high overdose rates. This program provides an innovative approach to engaging vulnerable groups into Substance Use Disorder treatment by focusing on SAMHSA's 8 dimensions of wellness (social determinants of health), 7 domains of citizenship, culturally informed education, and referral to Medication Assisted Treatment defined as any Food and Drug Administration approved pharmacotherapy for treating Substance Use Disorder. The Community Based Participatory Research process, which incorporates learning from and partnering with the church and larger community (including providers and policymakers), aims to increase the community's understanding of Alcohol Use Disorder and Opioid Use Disorder, tackle Medication Assisted Treatment misconceptions, optimize IMANI implementation, and establish policy recommendations for the healthcare systems to better serve people with Substance Use Disorder. The specific aims are: Specific Aim 1: To evaluate the impact of Imani + a church-based telehealth Medicine Assisted Treatment option (Imani + CTM) compared to Imani + Traditional MAT referral and linkage option (Imani + MAT R&L) on medication for addiction treatment initiation and engagement. Specific Aim 2: To assess whether there are changes in substance use over time for Imani+ CTM compared to Imani + Traditional MAT R&L. Specific Aim 3: To evaluate potential mediators and moderators (e.g., choice, SDOH) of improvements in primary SUD outcomes (initiation, engagement, and decreased substance use). Exploratory Aim 1: To assess differences in the 7 domains of citizenship and 8 dimensions of wellness (social determinants of health) comparing those enrolled in a MAT condition to those NOT enrolled in a MAT condition.

Interventions

BEHAVIORALIMANI

For the intervention, the study will introduce and offer Medication Assisted Treatment. Those participants wishing to receive MAT will be randomized to one of two intervention IMANI + church-based telehealth MAT or IMANI + Traditional MAT + Referral and Linkage. Those who do not wish to partake of MAT services will remain in the IMANI alone.

BEHAVIORALTelehealth MAT

Describe what is the Telehealth MAT briefly

BEHAVIORALTraditional MAT plus Referral and Linkage

Describe what he traditional MAT plus referral and linkage briefly

Sponsors

Yale University
Lead SponsorOTHER
National Institutes of Health (NIH)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Participants must meet criteria for a DSM-5 Alcohol Use Disorder and/or Opioid Use Disorder and are currently using alcohol and/or other opioids within the last 28 days. * Are interested in reducing substance use. * Self-identify as living in a geographical area with high overdose case rates

Exclusion criteria

\- Participants who do not sign informed consent

Design outcomes

Primary

MeasureTime frameDescription
Overall attendance of programUp to 24 weeksThe total number of sessions that participants attend will be used to measure continuation of program.
Overall treatment adherenceBaselineThe number of participants that adhere to treatments will be measured using self-report at three time points.

Secondary

MeasureTime frameDescription
Change in substance abuseWeekly for 24 weeksUsing urine toxicology strips the research staff will test the weekly urine provided by all participants for drugs use.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORChyrell Bellamy, Ph.D.

Yale University

PRINCIPAL_INVESTIGATORAyana Jordan, PhD.

Yale University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 9, 2026