Clinical trial NCT06032559: Implementation and Effectiveness of Mindfulness Oriented Recovery Enhancement as an Adjunct to Methadone Treatment
Official title: Implementation and Effectiveness of Mindfulness Oriented Recovery Enhancement as an Adjunct to Methadone Treatment for Opioid Use Disorder and Chronic Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Opioid Use
Pain
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: University of Utah
First posted: 2023-09-13
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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).

Primary outcomes:
measure: Days of drug use
timeFrame: Baseline through 52 weeks
Secondary outcomes:
measure: Chronic Pain
timeFrame: Baseline through 52 weeks
Other outcomes:
Locations:
city: New Brunswick
country: United States
facility: Rutgers Robert Wood Johnson Medical School
state: New Jersey
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: Rutgers Robert Wood Johnson Medical School
name: Eric Garland, Ph
role: PRINCIPAL_INVESTIGATOR
References: