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Can mindfulness and peer support boost opioid treatment success?

NCT ID NCT05363371

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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a program called Minds and Mentors that combines mindfulness training with peer support to help people stick with their medication for opioid use disorder. About 240 adults currently on medication like methadone or buprenorphine will be randomly assigned to either this program or a standard 12-step group. The goal is to see if the program improves medication adherence, reduces relapse and cravings, and lowers stress and anxiety.

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

About 240 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2022

Expected to finish

May 2027

An estimate. End dates often move.

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

19 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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. Age 19 and older 2. Opioid Use disorder diagnosis based on DSM-V criteria in the past 30 days 3. Currently receiving MOUD (e.g. methadone, naloxone, naltrexone, and buprenorphine) from an established provider 4. Are within maintenance phase of MOUD (not actively detoxing) 5. May meet criteria for a mood, anxiety, or other psychiatric disorder based on the DSM-V criteria. Participants on maintenance medications for a mood or anxiety disorder must be stabilized on medications for at least 2 weeks before therapy initiation 6. Capable of reading and understanding English 7. Able to provide written informed consent (i.e. no surrogate) 8. Access to a smartphone or a computer with an internet connection 9. Willing to commit to 12 group therapy sessions, baseline, and follow-up assessments for 24 weeks after the end of treatment (9- month total) Exclusion Criteria: 1. Significant cognitive impairment 2. Women who are pregnant (does not impact eligibility post study initiation) 3. Actively suicidal or homicidal 4. Active psychosis and/ or 5. Unstable medical conditions that contraindicate proposed treatment Subject Exit criteria: 1. Increases in alcohol or drug use leading to the need for a more intensive level of care (i.e., medical detoxification, inpatient) 2. Newly developed active suicidal or homicidal ideation 3. Inability to manage psychiatric symptoms within the inclusion/exclusion criteria of the study (i.e., need for the initiation of maintenance psychotropic medications; development of psychosis). If it is determined, based on clinical criteria, that a participant needs to be started on maintenance medications for anxiety, mood or psychotic symptoms during the study, they will be discontinued from the treatment trial 4. Inability to return for therapy sessions for four consecutive weeks.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Birmingham Veteran Affairs Medical Center

    Birmingham, Alabama, 35233, United States

  • Pathway Healthcare, LLC

    Birmingham, Alabama, 35235, United States

  • Tuscaloosa Veteran Affairs Medical Center

    Tuscaloosa, Alabama, 35404, United States

  • University of Alabama

    Tuscaloosa, Alabama, 35487, United States

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