Minds and Mentors Program for Opioid Use Disorder

(MiMP Trial)

Not currently recruiting at 3 trial locations
MN
RA
Overseen ByRebecca Allen, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Alabama, Tuscaloosa
Must be taking: MOUD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the effectiveness of a new program, Minds and Mentors, for individuals with opioid use disorder who are already taking medications like methadone or naltrexone. Participants will be randomly assigned to either the Minds and Mentors program, which combines mindfulness and peer mentoring, or a traditional Twelve Step program. The research will explore whether Minds and Mentors helps participants adhere to their medication, reduces cravings, and lowers stress and anxiety. Individuals diagnosed with opioid use disorder, currently on medication, and not actively detoxing might be suitable for this trial. Participants must be willing to attend group sessions and have access to a smartphone or computer.

As an unphased trial, this study offers a unique opportunity to explore innovative treatment options and contribute to groundbreaking research.

Do I have to stop taking my current medications for the trial?

No, you don't have to stop taking your current medications. In fact, you need to be stable on your medications for mood or anxiety disorders for at least two weeks before starting the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

A previous study on the Minds and Mentors Program (MiMP), which combines mindfulness-based relapse prevention and peer mentoring, showed promise for individuals with substance use disorders. Research has shown that mindfulness-based methods, like those in MiMP, are generally easy for participants to manage, with many finding them acceptable and practical. Importantly, these studies did not report any major safety concerns, suggesting the treatment is relatively safe.

For those considering such programs, it is reassuring to know that these mindfulness techniques aim to help without adding significant risk. Participants often report reduced cravings and stress, which can benefit those dealing with opioid use disorder. Always consult healthcare providers for personalized advice.12345

Why are researchers excited about this trial?

Researchers are excited about the Minds and Mentors Program for opioid use disorder because it combines mindfulness-based relapse prevention with peer mentoring, offering a fresh approach to treatment. Unlike traditional options like methadone or buprenorphine, which focus on managing withdrawal symptoms, this program emphasizes mental resilience and community support. The unique combination of group therapy led by both licensed counselors and peer mentors aims to provide a supportive network and practical skills to reduce the risk of relapse, offering a more holistic approach to recovery.

What evidence suggests that this trial's treatments could be effective for opioid use disorder?

Research has shown that mindfulness-based relapse prevention (MBRP), which participants in this trial may receive as part of the Minds and Mentors Program, can help treat opioid addiction. Studies have found that MBRP reduces cravings, relapse rates, and feelings of anxiety and depression. The program combines mindfulness techniques with peer support, aiding adherence to medication for opioid addiction. Previous studies indicate that these combined methods yield better results than traditional treatments alone. This evidence suggests that the Minds and Mentors Program could effectively manage opioid addiction. Meanwhile, another group in this trial will participate in a 12 Step Treatment Program, serving as an active comparator.13467

Are You a Good Fit for This Trial?

This trial is for adults over 19 with opioid use disorder who are currently on medication-assisted treatment (like methadone or buprenorphine). They must be stable on their medication, able to attend 12 therapy sessions and follow-ups for 9 months, have internet access, and not be in immediate need of intensive care like detox. Pregnant women, those with unstable medical conditions or active psychosis, suicidal thoughts, or significant cognitive impairment cannot join.

Inclusion Criteria

Are within maintenance phase of MOUD (not actively detoxing)
I am 19 years old or older.
Opioid Use disorder diagnosis based on DSM-V criteria in the past 30 days
See 6 more

Exclusion Criteria

Actively suicidal or homicidal
Active psychosis
I am not currently pregnant.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the Minds and Mentors Program or Twelve Step Facilitation for 12 weeks

12 weeks
12 visits (in-person, weekly)

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 weeks
Follow-up assessments at 12 and 24 weeks post-treatment

What Are the Treatments Tested in This Trial?

Interventions

  • Minds and Mentors
  • Twelve Step Intervention Group

Trial Overview

The study tests the Minds and Mentors Program against a Twelve Step Facilitation program for people using medications to treat opioid addiction. Participants will randomly receive one of these treatments in groups of five. The goal is to see if the program helps stick to treatment better, reduces relapse and cravings, lowers anxiety/stress/depression levels, and affects cortisol related to drug cues.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Mindfulness based relapse prevention and peer mentoringExperimental Treatment1 Intervention
Group II: 12 Step Treatment ProgramActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Alabama, Tuscaloosa

Lead Sponsor

Trials
49
Recruited
17,900+

University of Alabama at Birmingham

Collaborator

Trials
1,677
Recruited
2,458,000+

Tuscaloosa Veterans Affairs Medical Center

Collaborator

Trials
6
Recruited
690+

Pathway Healthcare, LLC

Collaborator

Trials
1
Recruited
240+

Citations

NCT04233671 | Minds and Mentors Program (MiMP)- R61

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 ...

The methods and baseline characteristics of a multi-site ... - PMC

This paper describes the methods and baseline characteristics of a multi-site randomized controlled trial evaluating the effectiveness of a combination of MBRP ...

Minds and Mentors Program- R33 (MiMP) - ClinicalTrials.Veeva

The purpose of this study is as follows: Test the effectiveness of the Minds and Mentors Program in a group treatment trial in which individuals ...

Minds and Mentors Program (MiMP)- R61

The goal of the proposed study is to determine the effectiveness of a mindfulness-based intervention that also utilizes peer mentors in addition ...

Minds and Mentors Program (MiMP)- R61

The purpose of this study is as follows: Test the feasibility and acceptability of a twelve- week mindfulness based relapse prevention protocol ...

Mindfulness-based Relapse Prevention for Substance Use ...

This review aims to estimate the effects and safety of Mindfulness-based Relapse Prevention (MBRP) for SUDs. ... extracted all outcome data. Data Synthesis.

7.

mindfulrp.com

mindfulrp.com/research

Research

Below are summaries of sample journal articles assessing the efficacy, effectiveness and mechanisms of mindfulness-based approaches to addictions treatment.