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

Part of paid clinical trials in New Brunswick, New Jersey.

Sponsor
Rutgers, The State University of New Jersey
Study ID
NCT06032559
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • MORE — BEHAVIORAL
    MORE plus TAU
  • SMP — BEHAVIORAL
    SMP plus TAU
  • TAU — OTHER
    TAU only

Study Details

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.

Key Dates

Start date
Sep 4, 2023
Status verified
Jul 2025
Primary completion
May 31, 2027
Completion
Jul 31, 2027

Study Design

Enrollment
450 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Rutgers Robert Wood Johnson Medical SchoolNew BrunswickNew Jersey08901
Nina Cooperman
[email protected]
7322358569
University of UtahSalt Lake CityUtah04108
Ericc Garland, PhD
[email protected]
(801) 581-3826

Find similar trials in New Brunswick, NJ

By condition
Substance use disorder
By specialty
Behavioral healthAddiction medicine
By research site
Rutgers Robert Wood Johnson Medical School· New Brunswick, NJUniversity of Utah· Salt Lake City, UT

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