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Behavioral Intervention
Culturally Tailored Recovery Programs for Substance Abuse (IMANI U Trial)
N/A
Recruiting
Led By Chyrell Bellamy, Ph.D.
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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 30 days
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12-month
Awards & highlights
IMANI U Trial Summary
This trial is testing ways to get more people of color into medication assisted treatment programs.
Who is the study for?
This trial is for Black or Latinx individuals who want to reduce substance use and have been diagnosed with Alcohol Use Disorder or Opioid Use Disorder, using substances within the last month. They must be interested in treatment and agree to participate by signing a consent form.Check my eligibility
What is being tested?
The study is testing culturally tailored recovery programs: IMANI, Telehealth MAT (Medication Assisted Treatment), and traditional MAT with extra support for accessing services. It aims to improve access and engagement in treatment among communities of color.See study design
What are the potential side effects?
While specific side effects are not detailed here, typical side effects from Medication Assisted Treatments can include nausea, headaches, dizziness, fatigue, mood swings, and potential withdrawal symptoms depending on the medication used.
IMANI U Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with an alcohol or opioid use disorder and have used these substances in the last 30 days.
IMANI U Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12-month
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12-month
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall attendance of program
Overall treatment adherence
Secondary outcome measures
Change in substance abuse
IMANI U Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: IMANI BREAKTROUGH + church-based telehealth MAT option (IMANI + CTM)Experimental Treatment2 Interventions
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.
Group II: IMANI BREAKTHROUGH + Traditional MAT plus Referral and LinkageExperimental Treatment2 Interventions
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.
Group III: IMANI BREAKTHROUGHActive Control1 Intervention
Participants will participate in 24-week IMANI weekly groups
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Who is running the clinical trial?
Yale UniversityLead Sponsor
1,848 Previous Clinical Trials
2,737,293 Total Patients Enrolled
17 Trials studying Substance Abuse
3,402 Patients Enrolled for Substance Abuse
National Institutes of Health (NIH)NIH
2,697 Previous Clinical Trials
6,952,289 Total Patients Enrolled
5 Trials studying Substance Abuse
1,346 Patients Enrolled for Substance Abuse
Chyrell Bellamy, Ph.D.Principal InvestigatorYale University
1 Previous Clinical Trials
204 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with an alcohol or opioid use disorder and have used these substances in the last 30 days.
Research Study Groups:
This trial has the following groups:- Group 1: IMANI BREAKTHROUGH + Traditional MAT plus Referral and Linkage
- Group 2: IMANI BREAKTHROUGH
- Group 3: IMANI BREAKTROUGH + church-based telehealth MAT option (IMANI + CTM)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are additional participants being taken into this investigation?
"The clinical trial is presently recruiting, according to information found on clinicaltrials.gov. It was first posted on July 11th 2022 and the last update occurred August 10th of that same year."
Answered by AI
What is the aggregate number of people involved in this experiment?
"Affirmative. According to clinicaltrials.gov, the medical trial commenced on July 11th 2022 and has had a recent update as of August 10th 2022. This requires 525 individuals across 7 sites for enrolment in total."
Answered by AI
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