Implementation and Effectiveness of Mindfulness Oriented Recovery Enhancement as an Adjunct to Methadone Treatment
NCT ID: NCT06032559
Last Updated: 2025-07-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
450 participants
INTERVENTIONAL
2023-09-04
2027-07-31
Brief Summary
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* 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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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MORE
Eight group sessions of Mindfulness-Oriented Recovery Enhancement plus methadone treatment as usual (TAU)
MORE
MORE plus TAU
Scripted Mindfulness Practice (SMP)
Eight group sessions of scripted mindfulness practice plus TAU.
SMP
SMP plus TAU
Treatment-as-Usual
Methadone treatment as usual.
TAU
TAU only
Interventions
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MORE
MORE plus TAU
SMP
SMP plus TAU
TAU
TAU only
Eligibility Criteria
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Inclusion Criteria
* age ≥18
* currently on methadone
* persistent or recurring pain that has lasted for a duration of 3 months of longer.
Exclusion Criteria
* 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).
18 Years
ALL
No
Sponsors
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National Institute on Drug Abuse (NIDA)
NIH
University of Utah
OTHER
Rutgers, The State University of New Jersey
OTHER
Responsible Party
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Nina A. Cooperman, Psy. D.
Associate Professor
Principal Investigators
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Eric Garland, Ph
Role: PRINCIPAL_INVESTIGATOR
Rutgers Robert Wood Johnson Medical School
Locations
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Rutgers Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States
University of Utah
Salt Lake City, Utah, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Pro2022001626
Identifier Type: -
Identifier Source: org_study_id
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