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Active, Not Recruiting

NCT Number: NCT05260047

Community Driven Substance Use Recovery for High Opioid Overdose Areas

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mount Aery Baptist Church, Bridgeport, Connecticut, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

IMANI

Behavioral

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.

Telehealth MAT

Behavioral

Describe what is the Telehealth MAT briefly

Traditional MAT plus Referral and Linkage

Behavioral

Describe what he traditional MAT plus referral and linkage briefly

Primary outcomes

  1. Overall attendance of program

    Time frame: Up to 24 weeks

    The total number of sessions that participants attend will be used to measure continuation of program.

  2. Overall treatment adherence

    Time frame: Baseline

    The number of participants that adhere to treatments will be measured using self-report at three time points.

  3. Overall treatment adherence

    Time frame: 6-month

    The number of participants that adhere to treatments will be measured using self-report at three time points.

  4. Overall treatment adherence

    Time frame: 12-month

    The number of participants that adhere to treatments will be measured using self-report at three time points.

Secondary outcomes

  1. Change in substance abuse

    Time frame: Weekly for 24 weeks

    Using urine toxicology strips the research staff will test the weekly urine provided by all participants for drugs use.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Acronym: IMANI U

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Mar 2, 2022
Registry last updated
Jun 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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