RECRUITING

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

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-09-04
Study Completion:2027-03-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06032559

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * English-speaking
  2. * age ≥18
  3. * currently on methadone
  4. * persistent or recurring pain that has lasted for a duration of 3 months of longer.
  1. * severe cognitive impairment (score \>23 on Mini Mental Status Exam) or psychosis (positive SCID Psychotic Screen)
  2. * suicidal risk (score ≥7 on Suicidal Behaviors Questionnaire)
  3. * inability to attend or fully participate in intervention sessions or assessments
  4. * previous formal mindfulness training (e.g., MBSR, MBRP) or MORE (from the R21 or R33 studies).

Contacts and Locations

Study Contact

Nina Cooperman, PsyD
CONTACT
732-235-8569
cooperna@rwjms.rutgers.edu
Eric Garland, PhD
CONTACT
801-581-3826
eric.garland@socwk.utah.edu

Principal Investigator

Eric Garland, Ph
PRINCIPAL_INVESTIGATOR
Rutgers Robert Wood Johnson Medical School

Study Locations (Sites)

Rutgers Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08901
United States
University of Utah
Salt Lake City, Utah, 04108
United States

Collaborators and Investigators

Sponsor: Rutgers, The State University of New Jersey

  • Eric Garland, Ph, PRINCIPAL_INVESTIGATOR, Rutgers Robert Wood Johnson Medical School

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-09-04
Study Completion Date2027-03-30

Study Record Updates

Study Start Date2023-09-04
Study Completion Date2027-03-30

Terms related to this study

Additional Relevant MeSH Terms

  • Opioid Use
  • Pain