Implementation and Effectiveness of Mindfulness Oriented Recovery Enhancement as an Adjunct to Methadone Treatment
Implementation and Effectiveness of Mindfulness Oriented Recovery Enhancement as an Adjunct to Methadone Treatment for Opioid Use Disorder and Chronic Pain
Who can join
Ages 18 and older · All sexes
Full eligibility 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).
About the study
This hybrid implementation-effectiveness trial will evaluate Mindfulness-Oriented Recovery Enhancement (MORE) for patients with opioid use disorder receiving methadone treatment (MT). The investigators will also assess barriers and facilitators to integrating MORE into methadone treatment, and evaluate the impact of a sustainable train-the-trainer model on provider burden, intervention fidelity, intervention engagement, and outcomes. Participants will be assigned to a higher intensity MORE implementation strategy, a minimal intensity implementation strategy consisting of a simple, scripted mindfulness practice (SMP) extracted from the MORE treatment manual with minimal training and feedback and no supervision, or methadone treatment as usual (TAU). We aim to:
* Examine barriers and facilitators to the implementation of MORE and SMP in MT and evaluate strategies for optimizing training, fidelity, and engagement. * Evaluate the effectiveness and treatment fidelity of a higher intensity MORE implementation strategy versus a lower intensity, scripted mindfulness practice (SMP) implementation strategy as an adjunct to methadone TAU or methadone TAU, only. Outcomes include opioid and other drug use, craving, MT discontinuation, depression, anxiety, and physical pain (secondary outcomes) than patients randomized to TAU.
What is being tested
- MORE (behavioral)
- SMP (behavioral)
- TAU (other)
Sponsor: Rutgers, The State University of New Jersey · Participants: 450 · Started: Sep 4, 2023
Contact the study team
- Nina Cooperman, PsyD · Phone: 732-235-8569
- Eric Garland, PhD · Phone: 801-581-3826
Official record on ClinicalTrials.gov — NCT06032559
Locations in the U.S.
| New Jersey | Rutgers Robert Wood Johnson Medical School, New Brunswick |
| Utah | University of Utah, Salt Lake City |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.