Minds and Mentors Program (MiMP)- R61

University of Alabama, Tuscaloosa

Status: Completed

Conditions: Opioid-use Disorder; Substance Use Disorders; Medication Assisted Treatment

Treatments: Behavioral: Mindfulness based relapse prevention and peer mentoring

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT04233671

1R61AT010802-01

Details and patient eligibility

About

The proposed research effort will:

The purpose of this study is as follows:

1. Test the feasibility and acceptability of a twelve- week mindfulness based relapse prevention protocol in combination with peer mentoring in individuals with opioid use disorder who are on medication assisted treatment.
2. Determine whether participation in a combination of mindfulness based relapse prevention and peer mentoring in comparison with an attentional control group: a) improves adherence to MAT b) decreases relapse and cravings c) improves psychosocial outcomes such as depression, anxiety, stress and social support

Full description

Although medication assisted therapy (MAT) for opioid use disorders (OUD) is safe and effective and is currently considered the gold standard for treating OUD, adherence to MAT regimens remains a challenge. The goal of the proposed study is to determine the effectiveness of a mindfulness-based intervention that also utilizes peer mentors in addition to professional substance abuse therapists (the Minds and Mentors program [MiMP]) in improving adherence to MAT for OUD and reducing relapse rates in a sample of individuals with OUD who are also on MAT versus a twelve-step facilitation (TSF) program. The MiMP is a twelve-week intervention that uses group therapy and meets once a week for about two hours for eight weeks with a professional substance abuse therapist; after the completion of eight therapist led sessions, participants will attend four weeks of group therapy sessions conducted by a peer mentor. The peer mentor will also attend the initial eight sessions with the therapist to establish rapport with participants. The control group will attend twelve weeks of a standard twelve-step facilitation program. This study will utilize an individually randomized group treatment design with ten participants in both the intervention and control groups. Data collection will occur at baseline, end of treatment, and at 3, 6, and 12- month follow-up.

Enrollment: 21 patients

Sex: All

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• At least 19 years old.
• Opioid Use disorder diagnosis based on Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-V) criteria in the past 30 days
• Currently receiving MAT for OUD (e.g. methadone, naloxone, naltrexone, and buprenorphine) from an established provider
• Are within maintenance phase of MAT (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)
• Willing to commit to 8 group therapy sessions, baseline, and follow-up assessments for 12-months after the end of treatment (14- month total)

Exclusion criteria

• Significant cognitive impairment
• Women who are pregnant
• 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 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
• Inability to return for therapy sessions due to incarceration or hospitalization lasting longer than four weeks.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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21 participants in 2 patient groups

Mindfulness based relapse prevention and peer mentoring

Experimental group

Description:

MiMP is a twelve week program, meeting once per week for 12 weeks for approximately two hours. Eight weeks are facilitated by a licensed counselor, and four weeks are facilitated by a peer mentor.

Treatment:

Behavioral: Mindfulness based relapse prevention and peer mentoring

12 Step Treatment Program Control

No Intervention group

Description:

The control group will meet for 12 weeks for standard 12 Step Facilitation meetings.