Implementation and Effectiveness of Mindfulness Oriented Recovery Enhancement as an Adjunct to Methadone Treatment (IMPOWR-MORE)

Rutgers The State University of New Jersey

Status and phase: Enrolling; Phase 3

Conditions: Opioid Use; Pain

Treatments: Behavioral: SMP; Other: TAU; Behavioral: MORE

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06032559

R01DA056537 (U.S. NIH Grant/Contract)

Pro2022001626

Details and patient eligibility

About

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.

Enrollment: 450 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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450 participants in 3 patient groups

MORE

Experimental group

Description:

Eight group sessions of Mindfulness-Oriented Recovery Enhancement plus methadone treatment as usual (TAU)

Treatment:

Behavioral: MORE

Scripted Mindfulness Practice (SMP)

Active Comparator group

Description:

Eight group sessions of scripted mindfulness practice plus TAU.

Treatment:

Behavioral: SMP

Treatment-as-Usual

Active Comparator group

Description:

Methadone treatment as usual.

Treatment:

Other: TAU