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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

Recruiting
18 years and older
All
Phase 3

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Overview

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

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).

Study details
    Opioid Use
    Pain

NCT06032559

Rutgers, The State University of New Jersey

26 January 2024

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