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Mindfulness may boost opioid treatment success

NCT ID NCT05042388

Disease control Sponsor: West Chester University of Pennsylvania Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether adding mindfulness-based relapse prevention (MBRP) to standard care helps people with opioid use disorder stay on their medication (extended-release naltrexone) and avoid drug use after leaving a residential treatment program. About 105 participants were randomly assigned to either MBRP or usual treatment and followed for three months after discharge. The goal was to see if MBRP improves medication adherence and reduces opioid relapse and craving.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Mindfulness-Based Relapse Prevention (MBRP) behavioral therapy
What this could lead to
If it works, this could offer a practical way to help people with opioid use disorder stay on their medication and reduce the chance of relapse after leaving residential treatment.
What could go wrong
This is a small, completed study (105 participants) testing a behavioral program, not a new drug. Results may not apply to everyone, and the benefits may be modest or hard to maintain long-term.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

105 people

The number who actually took part.

Started

Aug 2021

Finished

Aug 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. An informed consent document voluntarily signed and dated by the subject. 2. Subject must understand and be able to read and write in English. 3. Enrollment in residential treatment at study site. 4. Physically healthy males and females, aged 18 or older, who meet criteria for opioid use disorder (based on Diagnostic and Statistical Manual 5th Edition criteria) as their primary diagnosis, who are enrolled in residential treatment at the collaborating study site. 5. Subject must be willing to be randomized to treatment condition. 6. Subjects who are willing and able to comply with scheduled visits and other study procedures. Exclusion Criteria: 1. Meets current or lifetime DSM-V criteria for schizophrenia or any psychotic disorder or organic mental disorder, including dementia-related psychosis as determined by the semi-structured interview. 2. Presence of any other psychiatric disorder that in the opinion of the PI will interfere with completion of the study or place the patient at heightened risk through participation in the study.

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Conditions

The condition(s) this trial relates to.

Behavior, Addictive opiate dependence

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Opioid use disorder

Contacts and locations

Locations

  • Gaudenzia, Inc. (West Chester House)

    West Chester, Pennsylvania, 19382, United States

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