Minds and Mentors Program (MiMP)- R61

Completed · Not applicable · Has a placebo group

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

In brief

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

Key facts

Study ID

NCT04233671

Run by

University of Alabama, Tuscaloosa

People needed

21

Starts

2020-01-28

Expected to finish

2021-08-31

Last updated by the study team

2023-07-21

Who can join

Age: 19 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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.

Where it is running

• Pathway Healthcare, LLC — Birmingham, Alabama, United States
• Fritz Clinic — Homewood, Alabama, United States

Full record on ClinicalTrials.gov

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