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

• Sponsor: Rutgers, The State University of New Jersey (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06032559
• Collaborator: National Institute on Drug Abuse (NIDA) (NIH), University of Utah (Other)
• Enrollment: 450
• Arms: 3
• Anticipated Duration (Months): 42.7

Study Details

Study Description

Brief Summary

This hybrid implementation-effectiveness trial will evaluate Mindfulness-Oriented Recovery Enhancement (MORE) for patients with opioid use disorder receiving methadone treatment (MT). We 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.

Condition or Disease	Intervention/Treatment	Phase
Opioid Use; Pain	Behavioral: MORE; Behavioral: SMP; Other: TAU	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 450 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Implementation and Effectiveness of Mindfulness Oriented Recovery Enhancement as an Adjunct to Methadone Treatment for Opioid Use Disorder and Chronic Pain
• Anticipated Study Start Date: Sep 6, 2023
• Anticipated Primary Completion Date: Mar 30, 2026
• Anticipated Study Completion Date: Mar 30, 2027

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. 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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 1. English-speaking; 2) age ≥18; 3) currently on methadone; and 4) persistent or recurring pain that has lasted for a duration of 3 months of longer.

Exclusion Criteria:

• 1. severe cognitive impairment (score >23 on Mini Mental Status Exam)76 or psychosis (positive SCID Psychotic Screen),77 2) suicidal risk (score ≥7 on Suicidal Behaviors Questionnaire),78 3) inability to attend or fully participate in intervention sessions or assessments, and 4) previous formal mindfulness training (e.g., MBSR, MBRP) or MORE (from the R21 or R33 studies).

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Rutgers, The State University of New Jersey
• National Institute on Drug Abuse (NIDA)
• University of Utah

Investigators

• Principal Investigator: Eric Garland, Ph, Rutgers Robert Wood Johnson Medical School

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Nina A. Cooperman, Psy. D., Associate Professor, Rutgers, The State University of New Jersey
• ClinicalTrials.gov Identifier: NCT06032559
• Other Study ID Numbers: Pro2022001626; R01DA056537
• First Posted: Sep 13, 2023
• Last Update Posted: Sep 13, 2023
• Last Verified: Sep 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Sep 13, 2023