Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT06032559 · ClinicalTrials.gov registry record · Phase 3
Implementation and Effectiveness of Mindfulness Oriented Recovery Enhancement as an Adjunct to Methadone Treatment
A Phase 3 study of Pain and Opioid Use, sponsored by Rutgers, The State University of New Jersey.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 450
- Enrollment target
- 2
- Study locations
NCT06032559: Recruiting Phase 3 study of Pain and Opioid Use, sponsored by Rutgers, The State University of New Jersey.
NCT06032559 is a Phase 3 study of Pain and Opioid Use that is actively recruiting participants, run by Rutgers, The State University of New Jersey. The registered enrollment target is 450 participants, above the 303-participant average among 374 other Pain trials with a reported enrollment target (49% higher). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06032559, a Phase 3 study of Pain and Opioid Use, is actively recruiting participants, sponsored by Rutgers, The State University of New Jersey.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 450 participants
- Enrollment target
- 2
- Study locations
Study 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.
Primary Outcome
mber of days of drug use as measured by self-reported days of use and biochemically verified use via drug screen.
Conditions Studied
Interventions
- OTHER TAU
- BEHAVIORAL MORE
- BEHAVIORAL SMP
Study Locations (2)
New Jersey
- Rutgers Robert Wood Johnson Medical School - New Brunswick
Utah
- University of Utah - Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 450 participants |
| Start Date | 2023-09-04 |
| Est. Completion | 2027-07-31 |
| Phase | Phase 3 |
What NCT06032559 shows while recruiting
NCT06032559 is an interventional study that assigns participants to a tested intervention. The registered 450 participants enrollment target is mid-sized for trials with a published cap, above the 303-participant average among 374 other Pain trials with a reported enrollment target (49% higher).
The record links to 2 conditions, with Pain appearing as the primary indexed condition, and to 3 interventions - of which TAU is the first listed.
NCT06032559 reports a single indexed study location in New Jersey, Utah.
Frequently Asked Questions
What is clinical trial NCT06032559 about?
NCT06032559 is a clinical study titled "Implementation and Effectiveness of Mindfulness Oriented Recovery Enhancement as an Adjunct to Methadone Treatment". 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 evalu...
What is the current status of trial NCT06032559?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 450 participants. The study started on 2023-09-04. Estimated completion is 2027-07-31.
What conditions does trial NCT06032559 study?
This clinical trial studies the following conditions: Pain, Opioid Use.
What interventions are being tested in trial NCT06032559?
The interventions under investigation include: TAU (OTHER), MORE (BEHAVIORAL), SMP (BEHAVIORAL).
Who is sponsoring clinical trial NCT06032559?
This trial is sponsored by Rutgers, The State University of New Jersey, which has 413 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06032559 being conducted?
This trial has 2 study locations across New Jersey, Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Pain
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06032559's enrollment target sits among peer trials
450 40th of 374 higher than 333 of 374 other Pain trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pain trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Effect of NSAIDs on Union, Opioid Utilization and Pain Management for Tibia Fractures: A Pragmatic, Randomized Controlled Trial
RECRUITING · Phase 3
-
Opioid-Free Orthopaedics
RECRUITING · Phase 3
-
Suzetrigine in Total Hip Arthroplasty
RECRUITING · Phase 3
-
Optimizing Chronic Pain Care With Mindfulness and Chronic Pain Management Visits
RECRUITING · Phase 3
-
Post-Op Pain Control for Prophylactic Intramedullary Nailing.
RECRUITING · Phase 3
-
Protocolized vs Discretionary Use of Opioids in Acute Pain
COMPLETED · Phase 3
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01257269 · 450 participants
Genotype and Phenotype Correlation in Hereditary Thrombotic Thrombocytopenic Purpura (Upshaw-Schulman Syndrome)
- NCT03047161 · 450 participants
Electrophysiology of Fetal Arrhythmia
- NCT03269630 · 450 participants
New Orleans Pulmonary Hypertension Biobank
- NCT04165070 · 450 participants · Phase 1
KEYMAKER-U01 Substudy 01A: Efficacy and Safety Study of Pembrolizumab (MK-3475) With or Without Chemotherapy When Used With Investigational Agents in Treatment-naïve Participants With Stage IV Non-small Cell Lung Cancer (NSCLC) (MK-3475-01A/KEYMAKER-U01A)
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI