Clinical trial Recruiting at 2 sites Phase 3 Interventional Ages 18 and up

Mindfulness training for patients on methadone treatment

Official title: Implementation and Effectiveness of Mindfulness Oriented Recovery Enhancement as an Adjunct to Methadone Treatment for Opioid Use Disorder and Chronic Pain

Run by Rutgers, The State University of New Jersey · NCT06032559 · Data updated 2026-11-12

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

PhasePhase 3
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment450 (estimated)
SponsorRutgers, The State University of New Jersey
Academic / other
Locations2 sites (New Brunswick, New Jersey and 1 other locations)
StatusRecruiting
StartedSeptember 4, 2023
Main results expectedMay 31, 2027
Study endsJuly 31, 2027
Registry record updatedJuly 30, 2025
Trial IDNCT06032559 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably not a fit

Patients with severe cognitive impairment, psychosis, or those who have previously undergone formal mindfulness training may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: Other studies have shown promise in integrating mindfulness practices into addiction treatment, suggesting potential for success in this approach.

Who can join: the full rules

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 it's running

  • 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.