Mindfulness-based program for treating opioid use disorder
A Mindfulness and Peer Mentoring Program to Improve Adherence to Medication Assisted Treatment for Opioid Use Disorders (R33 Phase)
NA · University of Alabama, Tuscaloosa · NCT05363371
This study is testing a mindfulness program with peer support to see if it helps people with opioid use disorder stick to their treatment and feel better overall.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 240 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | University of Alabama, Tuscaloosa (other) |
| Locations | 4 sites (Birmingham, Alabama and 3 other locations) |
| Trial ID | NCT05363371 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of the Minds and Mentors Program, a mindfulness-based intervention combined with peer mentoring, for individuals with opioid use disorder who are receiving medication-assisted treatment. Participants will be randomly assigned to either the Minds and Mentors Program or a Twelve Step Facilitation program over a twelve-week period. The study aims to improve adherence to medication, reduce relapse rates, and decrease symptoms of anxiety, stress, and depression. Additionally, it will explore the relationship between cortisol levels and relapse outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 19 and older with a recent diagnosis of opioid use disorder who are currently receiving medication-assisted treatment.
Not a fit: Patients with significant cognitive impairment or those who are pregnant may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly improve treatment adherence and reduce relapse rates for patients with opioid use disorder.
How similar studies have performed: Previous studies have shown promising results for mindfulness-based interventions in treating substance use disorders, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Birmingham, Alabama and 3 other locations
- Birmingham Veteran Affairs Medical Center — Birmingham, Alabama, United States (ACTIVE_NOT_RECRUITING)
- Pathway Healthcare, LLC — Birmingham, Alabama, United States (COMPLETED)
- Tuscaloosa Veteran Affairs Medical Center — Tuscaloosa, Alabama, United States (ACTIVE_NOT_RECRUITING)
- University of Alabama — Tuscaloosa, Alabama, United States (RECRUITING)
Study contacts
- Study coordinator: Mercy N Mumba, PhD
- Email: mnmumba@ua.edu
- Phone: 682-521-0423
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Opioid Use Disorder, Substance Use Disorders, Medication Assisted Treatment, Mindfulness based therapy, Cravings, Relapse prevention, Treatment retention, Depression