Opioid Use, Pain
Conditions
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.
Sponsors
National Institute on Drug Abuse (NIDA)
University of Utah
Rutgers, The State University of New Jersey
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Days of drug use | Baseline through 52 weeks | mber of days of drug use as measured by self-reported days of use and biochemically verified use via drug screen. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Chronic Pain | Baseline through 52 weeks | Chronic pain measured by the Brief Pain Inventory Short Form (range 0-10, with higher scores indicating worse pain). |
Countries
United States
Contacts
Primary ContactNina Cooperman, PsyD
Backup ContactEric Garland, PhD
Outcome results
None listed