Recruiting
Phase 3

Mindfulness Oriented Recovery Enhancement with Methadone

Sponsor:

Rutgers, The State University of New Jersey

Code:

NCT06032559

Conditions

Opioid Use

Pain

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

MORE

SMP

TAU

Study Details

Brief summary:

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

Opioid Use

Pain

Study ID

NCT06032559

Start date

Sep 4, 2023

Status verified date

Jul, 2025

Completion date

Jul 31, 2027

Anticipated

Primary completion date

May 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

450 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: MORE

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

active comparator: Scripted Mindfulness Practice (SMP)

Eight group sessions of scripted mindfulness practice plus TAU.

active comparator: Treatment-as-Usual

Methadone treatment as usual.

Interventions

MORE

MORE plus TAU

SMP

SMP plus TAU

TAU

TAU only

Primary outcome measure

  • Days of drug use [ Time Frame: Baseline through 52 weeks ]

Central Contacts and Locations

Central contacts

Locations

Rutgers Robert Wood Johnson Medical School

Recruiting

New Brunswick, New Jersey, United States, 08901

Contacts

University of Utah

Recruiting

Salt Lake City, Utah, United States, 04108

Contacts

More Information

Sponsor

Rutgers, The State University of New Jersey

Last update posted

Jul 30, 2025

Last verified

Jul, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Rutgers, The State University of New Jersey on 2025-07-30.