RecruitingNot ApplicableNCT05363371

Minds and Mentors Program- R33

A Mindfulness and Peer Mentoring Program to Improve Adherence to Medication Assisted Treatment for Opioid Use Disorders (R33 Phase)

Sponsor

University of Alabama, Tuscaloosa

Enrollment

240 participants

Start Date

Jan 4, 2022

Study Type

INTERVENTIONAL

Conditions

Substance Use Disorders Opioid-use Disorder Medication Assisted Treatment

Summary

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.

Eligibility

Min Age: 19 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a mental health support program (combining therapy and peer mentoring) for people who are being treated for opioid use disorder with medications like methadone, buprenorphine, or naltrexone, and who may also have anxiety or depression. **You may be eligible if...** - You are 19 or older - You have been diagnosed with opioid use disorder in the past 30 days - You are currently taking a medication for opioid use disorder (e.g., methadone, buprenorphine, naltrexone) and are in the maintenance phase (not actively detoxing) - You can read and understand English - You may also have a mood or anxiety disorder, provided your medications have been stable for at least 2 weeks **You may NOT be eligible if...** - You are actively detoxing from opioids - You cannot read or understand English - You have other active substance use disorders (beyond opioids) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALMinds and Mentors

Participants will be randomized into Minds and Mentors to attend weekly group therapy sessions for 12 week. The mindfulness-based relapse prevention therapy intervention will be led by a licensed counselor for eights weeks followed up by four additional sessions led by a certified recovery support specialist (peer mentor).

BEHAVIORALTwelve Step Intervention Group

Participants will be randomized to the Twelve Step Intervention Group to attend weekly group therapy sessions for 12 week. The twelve step intervention group will be led by a licensed counselor.