Implementation and Effectiveness of Mindfulness Oriented Recovery Enhancement as an Adjunct to Methadone Treatment
Public ClinicalTrials.gov record NCT06032559. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Implementation and Effectiveness of Mindfulness Oriented Recovery Enhancement as an Adjunct to Methadone Treatment for Opioid Use Disorder and Chronic Pain
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT06032559
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 450 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 3, 2023
- Primary completion
- May 30, 2027
- Completion
- Jul 30, 2027
- Last update posted
- Jul 29, 2025
2023 – 2027
United States locations
- U.S. sites
- 2
- U.S. states
- 2
- U.S. cities
- 2
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Rutgers Robert Wood Johnson Medical School | New Brunswick | New Jersey | 08901 | Recruiting |
| University of Utah | Salt Lake City | Utah | 04108 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06032559, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 29, 2025 · Synced Sep 7, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06032559 live on ClinicalTrials.gov.