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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
Must not have
inability to attend or fully participate in intervention sessions or assessments
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline through 52 weeks
Awards & highlights
No Placebo-Only Group
Pivotal 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.
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.
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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I can attend and fully participate in all sessions and assessments.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Days of drug use
Secondary study objectives
Chronic Pain

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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.

Find a Location

Who is running the clinical trial?

Rutgers, The State University of New JerseyLead Sponsor
450 Previous Clinical Trials
65,374 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,587 Previous Clinical Trials
3,328,098 Total Patients Enrolled
University of UtahOTHER
1,141 Previous Clinical Trials
1,697,349 Total Patients Enrolled
~240 spots leftby Mar 2026
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