Mindfulness training for patients on methadone treatment
Implementation and Effectiveness of Mindfulness Oriented Recovery Enhancement as an Adjunct to Methadone Treatment for Opioid Use Disorder and Chronic Pain
This study is testing if adding mindfulness training to methadone treatment can help people with opioid use disorder manage their pain and reduce their opioid use.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 450 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Rutgers, The State University of New Jersey Academic / other |
| Locations | 2 sites (New Brunswick, New Jersey and 1 other locations) |
| Trial ID | NCT06032559 on ClinicalTrials.gov |
What this trial studies
This trial evaluates the effectiveness of Mindfulness-Oriented Recovery Enhancement (MORE) as an adjunct to methadone treatment for patients with opioid use disorder. Participants will be assigned to either a higher intensity MORE implementation strategy, a minimal intensity mindfulness practice, or standard methadone treatment. The study will also explore barriers and facilitators to integrating mindfulness practices into methadone treatment and assess the impact of a train-the-trainer model on provider engagement and treatment outcomes. The goal is to optimize training and evaluate the effectiveness of these interventions in managing pain and opioid use.
Who should consider this trial
Good fit: Ideal candidates are English-speaking adults aged 18 and older who are currently on methadone and experiencing persistent pain lasting three months or longer.
Not a fit: Patients with severe cognitive impairment, psychosis, or those who have previously undergone formal mindfulness training may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance recovery outcomes for patients with opioid use disorder by integrating mindfulness techniques into their treatment.
How similar studies have performed: Other studies have shown promise in integrating mindfulness practices into addiction treatment, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * English-speaking * age ≥18 * currently on methadone * persistent or recurring pain that has lasted for a duration of 3 months of longer. Exclusion Criteria: * severe cognitive impairment (score \>23 on Mini Mental Status Exam) or psychosis (positive SCID Psychotic Screen) * suicidal risk (score ≥7 on Suicidal Behaviors Questionnaire) * inability to attend or fully participate in intervention sessions or assessments * previous formal mindfulness training (e.g., MBSR, MBRP) or MORE (from the R21 or R33 studies).
Where this trial is running
New Brunswick, New Jersey and 1 other locations
- Rutgers Robert Wood Johnson Medical School — New Brunswick, New Jersey, United States (Recruiting)
- University of Utah — Salt Lake City, Utah, United States (Recruiting)
Study contacts
- Principal investigator: Eric Garland, Ph — Rutgers Robert Wood Johnson Medical School
- Study coordinator: Nina Cooperman, PsyD
- Email: cooperna@rwjms.rutgers.edu
- Phone: 732-235-8569
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.