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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Pain; Opioid Use
• Intervention / Treatment: Behavioral: MORE; Behavioral: SMP; Other: TAU

• Study Type: Interventional
• Enrollment (Estimated): 450
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Eric Garland, PhD; Phone Number: 801-581-3826; Email: eric.garland@socwk.utah.edu
• Study Contact Backup: Name: Nina Cooperman, PsyD; Phone Number: 732-235-8569; Email: cooperna@rwjms.rutgers.edu

Study Locations

• United States
  • New Jersey
    • New Brunswick, New Jersey, United States, 08901
      • Recruiting
      • Rutgers Robert Wood Johnson Medical School
      • Contact: Nina Cooperman; Phone Number: 7322358569; Email: cooperna@rwjms.rutgers.edu
  • Utah
    • Salt Lake City, Utah, United States, 04108
      • Recruiting
      • University of Utah
      • Contact: Ericc Garland, PhD; Phone Number: (801) 581-3826; Email: Eric.Garland@socwk.utah.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Rutgers, The State University of New Jersey
• Collaborators: National Institute on Drug Abuse (NIDA); University of Utah
• Investigators: Principal Investigator: Eric Garland, Ph, Rutgers Robert Wood Johnson Medical School

Study record dates

Study Major Dates

• Study Start (Actual): September 4, 2023
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): July 31, 2027

Study Registration Dates

• First Submitted: September 4, 2023
• First Submitted That Met QC Criteria: September 4, 2023
• First Posted (Actual): September 13, 2023

Study Record Updates

• Last Update Posted (Actual): July 30, 2025
• Last Update Submitted That Met QC Criteria: July 29, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: Pro2022001626; R01DA056537 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All participant data collected during the trial will be shared after de-identification.
• IPD Sharing Time Frame: Beginning 3 months and ending five years after study publication.
• IPD Sharing Access Criteria: Researchers who provide a methodologically sound proposal.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No