Who is eligible for clinical trial NCT05363371?

Participants must meet protocol criteria for Opioid Use Disorder. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT05363371 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-05-05

Minds and Mentors Program- R33 (NCT05363371)

🔵 Active, Not Recruiting Observational / Diagnostic 🧠 Behavioral & Psychological Program Sponsor: University of Alabama, Tuscaloosa

🩺 Plain-English Summary (8th-Grade Level)

The proposed research effort will: The purpose of this study is as follows: 1. Test the effectiveness of the Minds and Mentors Program in a group treatment trial in which individuals using medications for opioid use disorder (MOUD) will be randomized in blocks of five to receive either the Minds and Mentors Program (n=120) or Twelve Step Facilitation (n=120). 2. Determine whether the MiMP: a) improves adherence to MOUD b) reduces the rate of relapse and cravings c) decreases self-reported anxiety, stress, and depression and d) reduces cortisol levels and cortisol reactivity to drug cues. 3. Examine whether pre-intervention cortisol reactivity is predictive of relapse outcomes, and/ or reductions in cortisol reactivity over the course of intervention mediate relapse outcomes.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (9 items) and avoid the listed exclusions (10 items).

Location: Birmingham Veteran Affairs Medical Center — Birmingham, Alabama

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Age 19 and older
Opioid Use disorder diagnosis based on DSM-V criteria in the past 30 days
Currently receiving MOUD (e.g. methadone, naloxone, naltrexone, and buprenorphine) from an established provider
Are within maintenance phase of MOUD (not actively detoxing)
May meet criteria for a mood, anxiety, or other psychiatric disorder based on the DSM-V criteria. Participants on maintenance medications for a mood or anxiety disorder must be stabilized on medications for at least 2 weeks before therapy initiation
Capable of reading and understanding English
Able to provide written informed consent (i.e. no surrogate)
Access to a smartphone or a computer with an internet connection
Willing to commit to 12 group therapy sessions, baseline, and follow-up assessments for 24 weeks after the end of treatment (9- month total)

Usually NOT eligible if any of the following apply:

Exclusion Criteria:
Significant cognitive impairment
Women who are pregnant (does not impact eligibility post study initiation)
Actively suicidal or homicidal
Active psychosis and/ or
Unstable medical conditions that contraindicate proposed treatment Subject Exit criteria:
Increases in alcohol or drug use leading to the need for a more intensive level of care (i.e., medical detoxification, inpatient)
Newly developed active suicidal or homicidal ideation
Inability to manage psychiatric symptoms within the inclusion/exclusion criteria of the study (i.e., need for the initiation of maintenance psychotropic medications; development of psychosis). If it is determined, based on clinical criteria, that a participant needs to be started on maintenance medications for anxiety, mood or psychotic symptoms during the study, they will be discontinued from the treatment trial
Inability to return for therapy sessions for four consecutive weeks.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (4 Sites)

Birmingham Veteran Affairs Medical Center — Birmingham, Alabama
Pathway Healthcare, LLC — Birmingham, Alabama
Tuscaloosa Veteran Affairs Medical Center — Tuscaloosa, Alabama
University of Alabama — Tuscaloosa, Alabama

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗