NCT05363371 Minds and Mentors Program- R33

Trial Parameters

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Brief 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 Criteria

Inclusion Criteria: 1. Age 19 and older 2. Opioid Use disorder diagnosis based on DSM-V criteria in the past 30 days 3. Currently receiving MOUD (e.g. methadone, naloxone, naltrexone, and buprenorphine) from an established provider 4. Are within maintenance phase of MOUD (not actively detoxing) 5. 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 6. Capable of reading and understanding English 7. Able to provide written informed consent (i.e. no surrogate) 8. Access to a smartphone or a computer with an internet connection 9. Willing to commit to 12 group therapy sessions, baseline, and follow-up assessments for 24 weeks after the end of treatment (9- month total) Exclusion Criteria: 1. Significant cognitive impairment 2. Women who are pregnant (does not impact eligibility post study initi

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