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

Study Overview
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Brief Summary
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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.

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

Conditions
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Opioid Use, Pain

Intervention / Treatment
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* Behavioral: MORE
* Behavioral: SMP
* Other: TAU


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MORE<br>Eight group sessions of Mindfulness-Oriented Recovery Enhancement plus methadone treatment as usual (TAU) | Behavioral: MORE<br>* MORE plus TAU<br>|
| Active Comparator: Scripted Mindfulness Practice (SMP)<br>Eight group sessions of scripted mindfulness practice plus TAU. | Behavioral: SMP<br>* SMP plus TAU<br>|
| Active Comparator: Treatment-as-Usual<br>Methadone treatment as usual. | Other: TAU<br>* TAU only<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Days of drug use | mber of days of drug use as measured by self-reported days of use and biochemically verified use via drug screen. | Baseline through 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chronic Pain | Chronic pain measured by the Brief Pain Inventory Short Form (range 0-10, with higher scores indicating worse pain). | Baseline through 52 weeks |