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NCT Number: NCT06032559

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

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

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

MORE

Behavioral

MORE plus TAU

SMP

Behavioral

SMP plus TAU

TAU

Other

TAU only

Primary outcomes

  1. Days of drug use

    Time frame: 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 outcomes

  1. Chronic Pain

    Time frame: Baseline through 52 weeks

    Chronic pain measured by the Brief Pain Inventory Short Form (range 0-10, with higher scores indicating worse pain).

Study contacts

Contact information is provided by the study sponsor or research team.

Eric Garland, PhD

CONTACT

[email protected]

801-581-3826

Nina Cooperman, PsyD

CONTACT

[email protected]

732-235-8569

Sponsors and collaborators

Lead sponsor

Rutgers, The State University of New Jersey

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)
  • University of Utah

Registry information

Official study title

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

Acronym: IMPOWR-MORE

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Sep 13, 2023
Registry last updated
Jul 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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