Minds and Mentors Program- R33

Running, not enrolling · Not applicable

Conditions studied: Opioid Use Disorder, Substance Use Disorders, Medication Assisted Treatment

In brief

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.

Key facts

Study ID

NCT05363371

Run by

University of Alabama, Tuscaloosa

People needed

240

Starts

2022-01-04

Expected to finish

2027-05-31

Last updated by the study team

2026-05-06

Who can join

Age: 19 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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