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Recruiting Phase 3 NCT06032559

Implementation and Effectiveness of Mindfulness Oriented Recovery Enhancement as an Adjunct to Methadone Treatment

Trial Parameters

Condition Opioid Use
Sponsor Rutgers, The State University of New Jersey
Study Type INTERVENTIONAL
Phase Phase 3
Enrollment 450
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2023-09-04
Completion 2027-05-31
All Conditions
Interventions
MORESMPTAU

Brief Summary

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.

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).

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