Minds and Mentors Program- R33

NCT05363371 | Active Not Recruiting DMC

• 1 other identifier: 4R33AT010802-02
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 4

Brief Summary

The proposed research effort will: The purpose of this study is as follows:

1. 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. 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. 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

Keywords

Opioid Use Disorder; Mindfulness based therapy; Cravings; Relapse prevention; Treatment retention; Depression; Stress; Anxiety; Cortisol; Peer Mentors

Outcome Measures

Primary Outcomes (1)

• Adherence Rate

  Adherence rate operationalized as number of weeks a participant continually receives MOUD as prescribed by primary provider for the duration of the intervention and follow-up period

  9 months

Secondary Outcomes (6)

• Relapse

  9 months

• Cravings

  9 months

• Depression

  9 months

• Stress

  9 months

• Anxiety

  9 months

Other Outcomes (1)

• Cortisol Reactivity

  9 months

Study Arms (2)

Mindfulness based relapse prevention and peer mentoring

EXPERIMENTAL

Treatment will utilize a group format. The twelve-week mindfulness based relapsed prevention group therapy intervention is co-led by a licensed counselor and a peer mentor for eight weeks, followed by group sessions led by peer mentors for an additional four weeks.

Behavioral: Minds and Mentors

12 Step Treatment Program

ACTIVE COMPARATOR

Participants in the attentional control group will attend 12 weeks of a enhanced 12 step treatment program.

Behavioral: Twelve Step Intervention Group

Interventions

Minds and Mentors BEHAVIORAL

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).

Mindfulness based relapse prevention and peer mentoring

Twelve Step Intervention Group BEHAVIORAL

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.

12 Step Treatment Program

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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 return for therapy sessions for four consecutive weeks.

Sponsors & Collaborators

• University of Alabama, Tuscaloosa: lead
• University of Alabama at Birmingham: collaborator
• Tuscaloosa Veterans Affairs Medical Center: collaborator
• Pathway Healthcare, LLC: collaborator

Study Sites (4)

Birmingham Veteran Affairs Medical Center

Birmingham, Alabama, 35233, United States

Location

Pathway Healthcare, LLC

Birmingham, Alabama, 35235, United States

Location

Tuscaloosa Veteran Affairs Medical Center

Tuscaloosa, Alabama, 35404, United States

Location

University of Alabama

Tuscaloosa, Alabama, 35487, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders; Substance-Related Disorders; Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Nursing

Study Record Dates

• First Submitted: May 2, 2022
• First Posted: May 5, 2022
• Study Start: January 4, 2022
• Primary Completion (Estimated): January 8, 2027
• Study Completion (Estimated): May 31, 2027
• Last Updated: May 6, 2026

Record last verified: 2026-05

Locations

US (4)