Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT06032559

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

Led by Rutgers, The State University of New Jersey · Updated on 2025-07-30

450

Participants Needed

2

Research Sites

203 weeks

Total Duration

On this page

Sponsors

R

Rutgers, The State University of New Jersey

Lead Sponsor

N

National Institute on Drug Abuse (NIDA)

Collaborating Sponsor

AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • English-speaking
  • Age 18 years or older
  • Currently receiving methadone treatment
  • Persistent or recurring pain lasting 3 months or longer
Not Eligible

You will not qualify if you...

  • Severe cognitive impairment or psychosis
  • Suicidal risk with high score on Suicidal Behaviors Questionnaire
  • Inability to attend or fully participate in sessions or assessments
  • Previous formal mindfulness training such as MBSR, MBRP, or MORE

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Rutgers Robert Wood Johnson Medical School

New Brunswick, New Jersey, United States, 08901

Actively Recruiting

2

University of Utah

Salt Lake City, Utah, United States, 04108

Actively Recruiting

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Research Team

N

Nina Cooperman, PsyD

CONTACT

E

Eric Garland, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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