An interventional study of IMANI and Telehealth MAT in Substance Use, Mental Health Issue and Opioid Use, sponsored by Yale University. Active, not recruiting at 8 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-08.
Sponsored by Yale University · Not applicable, Interventional, and Treatment
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.
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.
2,124 studies on the registry are indexed under Substance-Related Disorders; 393 are open to participants now.
This study's planned enrollment of 525 is above the median of 108 across 1,727 interventional studies indexed under Substance-Related Disorders.
Browse Substance-Related Disorders studies →Yale University is the lead sponsor of 1,724 studies on the registry; 298 are open to participants now.
Of its 210 completed or terminated interventional studies of FDA-regulated products, 126 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
- Participants who do not sign informed consent
Participants will participate in 24-week IMANI weekly groups
Behavioral: IMANI
Participants will participate in the 24-week Imani weekly group. During weeks 1-4 participants will received education on MAT. Those participants randomized will receive the IMANI weekly group as well as a church based telehealth Medication Assisted Treatment option. The church based telehealth MAT will consist of participants assigned to receive MAT from addiction treatment providers via telehealth. Telehealth sessions will be provided in the church.
Behavioral: IMANI · Behavioral: Telehealth MAT
Participants will participate in the 24-week Imani weekly group. During weeks 1-4 participants will received education on MAT. Those participants randomized will receive the IMANI weekly group as well as Traditional MAT services with Referral and Linkage to services. Participants in this arm will be provided a list of referrals and links to community MAT providers. They will choose their providers.
Behavioral: IMANI · Behavioral: Traditional MAT plus Referral and Linkage
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.
Describe what is the Telehealth MAT briefly
Describe what he traditional MAT plus referral and linkage briefly
Overall attendance of program
The total number of sessions that participants attend will be used to measure continuation of program.
Time frame: Up to 24 weeks
Overall treatment adherence
The number of participants that adhere to treatments will be measured using self-report at three time points.
Time frame: Baseline
Overall treatment adherence
The number of participants that adhere to treatments will be measured using self-report at three time points.
Time frame: 6-month
Overall treatment adherence
The number of participants that adhere to treatments will be measured using self-report at three time points.
Time frame: 12-month
Change in substance abuse
Using urine toxicology strips the research staff will test the weekly urine provided by all participants for drugs use.
Time frame: Weekly for 24 weeks
Plan to share: No
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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