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Minds and Mentors Program for Opioid Use Disorder (MiMP Trial)

N/A
Recruiting
Research Sponsored by University of Alabama, Tuscaloosa
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 19 and older
Currently receiving MOUD (e.g. methadone, naloxone, naltrexone, and buprenorphine) from an established provider
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 9 months
Awards & highlights

MiMP Trial Summary

This trial will test the effectiveness of the Minds and Mentors Program (MiMP) in treating individuals with opioid use disorder. The study will compare the MiMP to Twelve Step Facilitation, and will measure outcomes such as adherence to medication, rates of relapse and cravings, and self-reported anxiety, stress, and depression. Additionally, the trial will examine whether pre-intervention cortisol reactivity is predictive of relapse outcomes, and/ or whether reductions in cortisol reactivity over the course of intervention mediate relapse outcomes.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Since this trial involves group therapy programs rather than medications beyond participants' current treatments for opioid use disorder (MOUD), there aren't new side effects from drugs being tested here. However, discussing sensitive topics during therapy could potentially cause emotional discomfort.

MiMP Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 19 years old or older.
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I am currently on medication for opioid use disorder.

MiMP Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~9 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 9 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Adherence Rate
Secondary outcome measures
Anxiety
Cravings
Depression
+3 more
Other outcome measures
Cortisol Reactivity

MiMP Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Mindfulness based relapse prevention and peer mentoringExperimental Treatment1 Intervention
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.
Group II: 12 Step Treatment ProgramActive Control1 Intervention
Participants in the attentional control group will attend 12 weeks of a enhanced 12 step treatment program.

Find a Location

Who is running the clinical trial?

University of Alabama, TuscaloosaLead Sponsor
44 Previous Clinical Trials
19,276 Total Patients Enrolled
University of Alabama at BirminghamOTHER
1,573 Previous Clinical Trials
2,273,037 Total Patients Enrolled
Tuscaloosa Veterans Affairs Medical CenterFED
5 Previous Clinical Trials
453 Total Patients Enrolled

Media Library

Minds and Mentors Clinical Trial Eligibility Overview. Trial Name: NCT05363371 — N/A
Opioid Use Disorder Research Study Groups: Mindfulness based relapse prevention and peer mentoring, 12 Step Treatment Program
Opioid Use Disorder Clinical Trial 2023: Minds and Mentors Highlights & Side Effects. Trial Name: NCT05363371 — N/A
Minds and Mentors 2023 Treatment Timeline for Medical Study. Trial Name: NCT05363371 — N/A
Opioid Use Disorder Patient Testimony for trial: Trial Name: NCT05363371 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are accepted in this experimental endeavor?

"Affirmative. According to the clinicaltrials.gov dataset, this medical research project is still recruiting participants - the trial was initially published on April 1st 2022 and underwent its last modification on July 25th of the same year. The initiative aims to enrol a total of 240 patients from 4 different hospitals."

Answered by AI

Is this experiment still recruiting participants?

"Affirmative, the information found on clinicaltrials.gov implies that this study is currently enrolling participants. The research was originally announced on April 1st 2022 and has been updated as recently as July 25th 2022. This trial requires a total of 240 candidates to be recruited at 4 distinct sites."

Answered by AI

Who else is applying?

What state do they live in?
Alabama
What site did they apply to?
Pathway Healthcare, LLC
University of Alabama
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0
3+

Why did patients apply to this trial?

Up to trying anything. I’ve tried AA(never felt comfortable enough to actually finish the steps and always relapse), I’ve tried quitting cold Turkey(made it 3 months), I’ve tried using other drugs (as much sense as that makes), and yeah I can get off of opiates for months even went a couple years without opiates (was on meth instead), but no matter what I always go back. I have overdosed and narcan used at least 5 times and it scares me that I still crave this.
PatientReceived 1 prior treatment

What questions have other patients asked about this trial?

Is it a paid?
PatientReceived 2+ prior treatments
~39 spots leftby Aug 2024