NCT06032559

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
450

participants targeted

Target at P50-P75 for phase_3

Timeline
16mo left

Started Sep 2023

Typical duration for phase_3

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress67%
Sep 2023Jul 2027

First Submitted

Initial submission to the registry

September 4, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

September 4, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 13, 2023

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2027

Last Updated

July 30, 2025

Status Verified

July 1, 2025

Enrollment Period

3.7 years

First QC Date

September 4, 2023

Last Update Submit

July 29, 2025

Conditions

Opioid UsePain

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Chronic Pain

    Baseline through 52 weeks

Study Arms (3)

MORE

EXPERIMENTAL

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

Behavioral: MORE

Scripted Mindfulness Practice (SMP)

ACTIVE COMPARATOR

Eight group sessions of scripted mindfulness practice plus TAU.

Behavioral: SMP

Treatment-as-Usual

ACTIVE COMPARATOR

Methadone treatment as usual.

Other: TAU

Interventions

MOREBEHAVIORAL

MORE plus TAU

MORE
SMPBEHAVIORAL

SMP plus TAU

Scripted Mindfulness Practice (SMP)
TAUOTHER

TAU only

Treatment-as-Usual

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Rutgers Robert Wood Johnson Medical School

New Brunswick, New Jersey, 08901, United States

RECRUITING

University of Utah

Salt Lake City, Utah, 04108, United States

RECRUITING

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Eric Garland, Ph

    Rutgers Robert Wood Johnson Medical School

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nina Cooperman, PsyD

CONTACT

732-235-8569cooperna@rwjms.rutgers.edu

Eric Garland, PhD

CONTACT

801-581-3826eric.garland@socwk.utah.edu

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 4, 2023

First Posted

September 13, 2023

Study Start

September 4, 2023

Primary Completion (Estimated)

May 31, 2027

Study Completion (Estimated)

July 31, 2027

Last Updated

July 30, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will share

All participant data collected during the trial will be shared after de-identification.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
Beginning 3 months and ending five years after study publication.
Access Criteria
Researchers who provide a methodologically sound proposal.

Locations

US(2)