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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 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.

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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.

Conditions Studied

Pain Opioid Use

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

FieldValue
Enrollment Target 450 participants
Start Date 2023-09-04
Est. Completion 2027-07-31
Phase Phase 3

Sponsor

Rutgers, The State University of New Jersey

413 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06032559

The ClinicalTrials.gov registry entry for NCT06032559 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 450 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 303-participant average among 374 other Pain trials with a reported enrollment target (49% higher). The listed sponsor is Rutgers, The State University of New Jersey, which has 413 total studies on file at ClinicalTrials.gov.

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 2 study locations spanning 2 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.