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Mindfulness Therapy + Methadone for Opioid Use Disorder (IMPOWR-MORE Trial)

Phase 3

Recruiting

Led By Eric Garland, Ph

Research Sponsored by Rutgers, The State University of New Jersey

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

age ≥18

currently on methadone

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline through 52 weeks

Awards & highlights

IMPOWR-MORE Trial Summary

This trial will study how mindfulness-oriented recovery enhancement can help opioid use disorder patients receiving methadone treatment. It will evaluate treatment fidelity, engagement, and outcomes.

Who is the study for?

This trial is for English-speaking adults over 18 who are on methadone treatment and have been experiencing pain for at least three months. It's not suitable for those unable to attend sessions, with severe cognitive issues or psychosis, at risk of suicide, or with previous formal mindfulness training.Check my eligibility

What is being tested?

The study tests Mindfulness-Oriented Recovery Enhancement (MORE) as an add-on to standard methadone treatment for opioid use disorder. Participants will try either a high-intensity MORE strategy, a minimal intensity scripted practice (SMP), or continue regular treatment without additional interventions.See study design

What are the potential side effects?

Since the interventions involve mindfulness practices rather than medications, typical drug side effects aren't expected. However, participants may experience emotional discomfort when engaging in deep reflection during mindfulness exercises.

IMPOWR-MORE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I am currently taking methadone.

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I have had pain that has lasted for more than 3 months.

IMPOWR-MORE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline through 52 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline through 52 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline through 52 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Days of drug use

Secondary outcome measures

Chronic Pain

IMPOWR-MORE Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: MOREExperimental Treatment1 Intervention

Eight group sessions of Mindfulness-Oriented Recovery Enhancement plus methadone treatment as usual (TAU)

Group II: Scripted Mindfulness Practice (SMP)Active Control1 Intervention

Eight group sessions of scripted mindfulness practice plus TAU.

Group III: Treatment-as-UsualActive Control1 Intervention

Methadone treatment as usual.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Rutgers, The State University of New JerseyLead Sponsor

429 Previous Clinical Trials

63,782 Total Patients Enrolled

National Institute on Drug Abuse (NIDA)NIH

2,470 Previous Clinical Trials

2,619,281 Total Patients Enrolled

25 Trials studying Pain

2,829 Patients Enrolled for Pain

University of UtahOTHER

1,100 Previous Clinical Trials

1,778,451 Total Patients Enrolled

22 Trials studying Pain

176,714 Patients Enrolled for Pain

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the Food and Drug Administration given its seal of approval to MORE?

"Our analysts at Power assigned MORE a rating of 3, indicating that there is sufficient data from multiple trials to support its safety profile."

Answered by AI

Is this research currently accepting participants?

"As per the information on clinicaltrials.gov, this medical trail is actively looking for participants. This trial was initially unveiled on September 4th 2023 and has been updated as recently October 7th 2023."

Answered by AI

How many participants are currently signed up for this clinical trial?

"Affirmative. Clinicaltrials.gov information suggests this clinical trial is enlisting patients, which was initially advertised on September 4th 2023 and last modified October 7th of the same year. From two distinct locations, this investigation requires 450 participants to take part in it."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Implementation and Effectiveness of Mindfulness Oriented Recovery Enhancement as an Adjunct to Methadone Treatment

Nina A. Cooperman, Psy. D. 2023. "Implementation and Effectiveness of Mindfulness Oriented Recovery Enhancement as an Adjunct to Methadone Treatment". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06032559.