Minds and Mentors Program- R33

Description

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.

Conditions

Opioid Use Disorder, Substance Use Disorders, Medication Assisted Treatment

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Study Overview

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Study Details

Study overview

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.

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

Minds and Mentors Program- R33

Condition
Opioid Use Disorder
Intervention / Treatment

-

Contacts and Locations

Birmingham

Birmingham Veteran Affairs Medical Center, Birmingham, Alabama, United States, 35233

Birmingham

Pathway Healthcare, LLC, Birmingham, Alabama, United States, 35235

Tuscaloosa

Tuscaloosa Veteran Affairs Medical Center, Tuscaloosa, Alabama, United States, 35404

Tuscaloosa

University of Alabama, Tuscaloosa, Alabama, United States, 35487

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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)
  • 1. Significant cognitive impairment
  • 2. Women who are pregnant (does not impact eligibility post study initiation)
  • 3. Actively suicidal or homicidal
  • 4. Active psychosis and/ or
  • 5. Unstable medical conditions that contraindicate proposed treatment
  • 1. Increases in alcohol or drug use leading to the need for a more intensive level of care (i.e., medical detoxification, inpatient)
  • 2. Newly developed active suicidal or homicidal ideation
  • 3. 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
  • 4. Inability to return for therapy sessions for four consecutive weeks.

Ages Eligible for Study

19 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

University of Alabama, Tuscaloosa,

Study Record Dates

2024-08-31