Minds and Mentors Program- R33 (MiMP)

University of Alabama, Tuscaloosa

Status: Enrolling

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

Treatments: Behavioral: Minds and Mentors; Behavioral: Twelve Step Intervention Group

Study type: Interventional

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

Identifiers

NCT05363371

4R33AT010802-02

Details and patient eligibility

About

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.

Full description

Although medications for opioid use disorders (MOUD) is safe and effective and is currently considered the gold standard for treating OUD, adherence to MOUD regimens remains a challenge. Early studies have demonstrated efficacy of mindfulness-based interventions as adjunctive treatment for substance use disorders (SUD) while reducing substance use and cravings. In addition, non-randomized pilot studies suggest that mindfulness-based interventions may be effective in reducing symptoms of depression and anxiety in individuals undergoing MOUD.

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 MOUD and reducing relapse rates in a sample of individuals with OUD who are also on MOUD 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. The primary outcome measure will is adherence to medications for OUD. The secondary outcome measures will include the demographic covariates, depression, anxiety, stress, quality of life, and cravings. Finally, exploratory outcome measures will include cortisol levels and rates of reactivity to drug cues. This study will randomize participants in either intervention or control group in blocks of five. Data collection will occur at baseline, 8 weeks, 12 weeks (end of treatment) and at 12- week and 24- week follow-up.

Enrollment: 240 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

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 initiation)
3. Actively suicidal or homicidal
4. Active psychosis and/ or
5. Unstable medical conditions that contraindicate proposed treatment

Subject Exit criteria:

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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240 participants in 2 patient groups

Mindfulness based relapse prevention and peer mentoring

Experimental group

Description:

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.

Treatment:

Behavioral: Minds and Mentors

12 Step Treatment Program

Active Comparator group

Description:

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

Treatment:

Behavioral: Twelve Step Intervention Group