Substance UseIMANI UNCT05260047
Community Driven Substance Use Recovery for High Opioid Overdose Areas
A study testing IMANI, Telehealth MAT and Traditional MAT plus Referral and Linkage in people with Substance Use and Mental Health Issue, run by Yale University at 8 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Substance Use, Mental Health Issue, Opioid Use
- What is being tested?
- IMANI, Telehealth MAT and Traditional MAT plus Referral and Linkage
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 525 participants
- Where
- 8 sitesUnited States
- Study dates
- 20 Jul 2022to 1 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Participants who do not sign informed consent
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Mount Aery Baptist Church
Bridgeport, Connecticut, 06604
Principe of Peace Church
Bridgeport, Connecticut, 06605
Blackwell Memorial AME Church
Hartford, Connecticut, 06002
Iglesia Nuevo Comienzo
Hartford, Connecticut, 06602
Spottswood AME
New Britain, Connecticut, 06053
Varick Memorial AME Church
New Haven, Connecticut, 06511
Yale Program for Recovery and Community Health
New Haven, Connecticut, 06513
Casa de Oracion y Adoracion
New Haven, Connecticut, 06519
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 of color.
Read the 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.
- Being tested
- IMANI, Telehealth MAT, Traditional MAT plus Referral and Linkage
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMANIBehavioural
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 MATBehavioural
Describe what is the Telehealth MAT briefly
Traditional MAT plus Referral and LinkageBehavioural
Describe what he traditional MAT plus referral and linkage briefly
| Study group | Role | What they receive |
|---|---|---|
| IMANI BREAKTHROUGH | Active comparator | Participants will participate in 24-week IMANI weekly groups Receives: Behavioral: IMANI |
| IMANI BREAKTROUGH + church-based telehealth MAT option (IMANI + CTM) | Experimental | 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. Receives: Behavioral: IMANI; Behavioral: Telehealth MAT |
| IMANI BREAKTHROUGH + Traditional MAT plus Referral and Linkage | Experimental | 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. Receives: Behavioral: IMANI; Behavioral: Traditional MAT plus Referral and Linkage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall attendance of program
The total number of sessions that participants attend will be used to measure continuation of program.
Measured: 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.
Measured: Baseline
Overall treatment adherence
The number of participants that adhere to treatments will be measured using self-report at three time points.
Measured: 6-month
Overall treatment adherence
The number of participants that adhere to treatments will be measured using self-report at three time points.
Measured: 12-month
Secondary outcomes (1)
Change in substance abuse
Using urine toxicology strips the research staff will test the weekly urine provided by all participants for drugs use.
Measured: Weekly for 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study start20 Jul 2022
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance UseStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 525 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Chyrell Bellamy, Ph.D., Principal investigator, Yale UniversityAyana Jordan, PhD., Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05260047
- Sponsor's protocol ID
- 2000031168
- Other IDs
- 1U01OD033241-01
- Acronym
- IMANI U
- Status last verified
- Jun 2026
- First submitted
- 11 Feb 2022
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community Driven Substance Use Recovery for High Opioid Overdose Areas
- ClinicalTrials.gov ID
- NCT05260047
- Acronym / sponsor ID
- IMANI U / 2000031168
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 525 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 20 Jul 2022 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 2 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| IMANI BREAKTHROUGH | Active comparator | Behavioral: IMANIParticipants will participate in 24-week IMANI weekly groups |
| IMANI BREAKTROUGH + church-based telehealth MAT option (IMANI + CTM) | Experimental | Behavioral: IMANI, Behavioral: Telehealth MATParticipants 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. |
| IMANI BREAKTHROUGH + Traditional MAT plus Referral and Linkage | Experimental | Behavioral: IMANI, Behavioral: Traditional MAT plus Referral and LinkageParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Participants who do not sign informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IMANIFor 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. | Behavioural | IMANI BREAKTHROUGH, IMANI BREAKTHROUGH + Traditional MAT plus Referral and Linkage, IMANI BREAKTROUGH + church-based telehealth MAT option (IMANI + CTM) |
| Telehealth MATDescribe what is the Telehealth MAT briefly | Behavioural | IMANI BREAKTROUGH + church-based telehealth MAT option (IMANI + CTM) |
| Traditional MAT plus Referral and LinkageDescribe what he traditional MAT plus referral and linkage briefly | Behavioural | IMANI BREAKTHROUGH + Traditional MAT plus Referral and Linkage |
Primary outcome
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.
Overall treatment adherence
Time frame: Baseline
The number of participants that adhere to treatments will be measured using self-report at three time points.
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.
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.
1 secondary outcome
Change in substance abuse
Time frame: Weekly for 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chyrell Bellamy, Ph.D. principal investigator
Yale University
Ayana Jordan, PhD. principal investigator
Yale University
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IMANI, Telehealth MAT and Traditional MAT plus Referral and Linkage in people with Substance Use and Mental Health Issue, run by Yale University at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall attendance of program (time frame: Up to 24 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026.