NCT06032559 Implementation and Effectiveness of Mindfulness Oriented Recovery Enhancement as an Adjunct to Methadone Treatment
| NCT ID | NCT06032559 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Rutgers, The State University of New Jersey |
| Condition | Opioid Use |
| Study Type | INTERVENTIONAL |
| Enrollment | 450 participants |
| Start Date | 2023-09-04 |
| Primary Completion | 2027-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 450 participants in total. It began in 2023-09-04 with a primary completion date of 2027-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
Contact & Investigator
Eric Garland, Ph
PRINCIPAL INVESTIGATOR
Rutgers Robert Wood Johnson Medical School
Frequently Asked Questions
Who can join the NCT06032559 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Opioid Use. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06032559 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 450 participants.
Is NCT06032559 currently recruiting?
Yes, NCT06032559 is actively recruiting participants. Contact the research team at cooperna@rwjms.rutgers.edu for enrollment information.
Where is the NCT06032559 trial being conducted?
This trial is being conducted at New Brunswick, United States, Salt Lake City, United States.
Who is sponsoring the NCT06032559 clinical trial?
NCT06032559 is sponsored by Rutgers, The State University of New Jersey. The principal investigator is Eric Garland, Ph at Rutgers Robert Wood Johnson Medical School. The trial plans to enroll 450 participants.