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

Phase 3

Recruiting

• Conditions: Pain; Opioid Use
• Interventions: Behavioral: MORE; Behavioral: SMP; Other: TAU

• Registration Number: NCT06032559
• Lead Sponsor: Rutgers, The State University of New Jersey

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-04
• Study First Submitted: 2023-09-04
• Study First Submitted QC: 2023-09-04
• Study First Posted: 2023-09-13
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-18
• Last Update Posted: 2025-02-20
• Primary Completion: 2026-03-30
• Study Completion: 2027-03-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 450

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MORE	MORE	Eight group sessions of Mindfulness-Oriented Recovery Enhancement plus methadone treatment as usual (TAU)
Scripted Mindfulness Practice (SMP)	SMP	Eight group sessions of scripted mindfulness practice plus TAU.
Treatment-as-Usual	TAU	Methadone treatment as usual.

Primary Outcome Measures

Name	Time	Method
Days of drug use	Baseline through 52 weeks	mber of days of drug use as measured by self-reported days of use and biochemically verified use via drug screen.

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Rutgers Robert Wood Johnson Medical School; 🇺🇸 New Brunswick, New Jersey, United States

University of Utah; 🇺🇸 Salt Lake City, Utah, United States