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

Inclusion Criteria9

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)

Exclusion Criteria9

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 return for therapy sessions for four consecutive weeks.

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.