Minds and Mentors Program (MiMP)- R61

NCT04233671 | Completed Results DMC

• 1 other identifier: 1R61AT010802-01
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 2

Brief Summary

The proposed research effort will: The purpose of this study is as follows:

1. 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. 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

Conditions

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

Keywords

Opioid Use Disorder; Mindfulness based therapy; cravings; relapse prevention; treatment retention; depression; stress; anxiety; cortisol; peer mentors

Outcome Measures

Primary Outcomes (1)

• Number of Days Adherence to Medication Assisted Treatment

  The primary outcome variable is adherence to medication-assisted therapy (MAT), quantified as the number of days MAT was received as indicated during the last 4 weeks of the intervention period. We expect that this can be treated as a continuous variable in regression models.

  Last 4 weeks of the intervention period

Secondary Outcomes (13)

• Feasibility of Mindfulness Based Relapse Prevention as Measured by Retention Rate

  12 months

• Acceptability and Adherence to Mindfulness Based Relapse Prevention as Measured by the Treatment Acceptability/Adherence (TAAS) Scale

  3 months - at the end of the 12 week intervention

• Satisfaction With the Intervention Program

  3 months - at the end of the 12 week intervention

• Acceptability of the Intervention Programs

  3 months

• Relapse Rate (Number of Participants With Relapse) as Determined by Urine Drug Screen

  Last four weeks of the 12-week intervention

Other Outcomes (1)

• Baseline Cortisol Reactivity to Drug Cues

  at baseline data collection

Study Arms (2)

Mindfulness based relapse prevention and peer mentoring

EXPERIMENTAL

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.

Behavioral: Mindfulness based relapse prevention and peer mentoring

12 Step Treatment Program Control

NO INTERVENTION

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

Interventions

Mindfulness based relapse prevention and peer mentoring BEHAVIORAL

Importantly, the treatment will utilize a group format. Group process can serve as a vital agent in breaking down client denial about drug abuse problems. Groups have also been shown to be suitable for treating problems commonly associated with substance abuse, including depression, isolation, and shame. Additionally, groups intrinsically have many rewarding benefits, including reducing isolation and enabling members to witness the recovery of others. The eight-week group therapy intervention is co-led by a licensed counselor and a peer mentor for eight weeks, then followed by group sessions led by peer mentors for an additional four weeks.

Mindfulness based relapse prevention and peer mentoring

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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 return for therapy sessions due to incarceration or hospitalization lasting longer than four weeks.

Sponsors & Collaborators

• University of Alabama, Tuscaloosa: lead
• University of Alabama at Birmingham: collaborator
• Tuscaloosa Veterans Affairs Medical Center: collaborator

Study Sites (2)

Pathway Healthcare, LLC

Birmingham, Alabama, 35235, United States

Location

Fritz Clinic

Homewood, Alabama, 35209, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders; Substance-Related Disorders; Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Results Point of Contact

• Title: Dr. Mercy Mumba
• Organization: The University of Alabama

mnmumba@ua.edu

205-348-6317

Study Officials

• Mercy N Mumba, PhD

  University of Alabama, Tuscaloosa

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Interventional Study Model: Parallel Assignment

Study Record Dates

• First Submitted: January 15, 2020
• First Posted: January 18, 2020
• Study Start: January 28, 2020
• Primary Completion: August 31, 2021
• Study Completion: August 31, 2021
• Last Updated: July 21, 2023
• Results First Posted: July 21, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)