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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other, Behavioral
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• English-speaking

• age ≥18

• currently on methadone

• persistent or recurring pain that has lasted for a duration of 3 months of longer.

Locations
United States
New Jersey
Rutgers Robert Wood Johnson Medical School
RECRUITING
New Brunswick
Utah
University of Utah
RECRUITING
Salt Lake City
Contact Information
Primary
Nina Cooperman, PsyD
cooperna@rwjms.rutgers.edu
732-235-8569
Backup
Eric Garland, PhD
eric.garland@socwk.utah.edu
801-581-3826
Time Frame
Start Date: 2023-09-04
Estimated Completion Date: 2027-07-31
Participants
Target number of participants: 450
Treatments
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.
Related Therapeutic Areas
Sponsors
Collaborators: National Institute on Drug Abuse (NIDA), University of Utah
Leads: Rutgers, The State University of New Jersey

This content was sourced from clinicaltrials.gov