Can mindfulness and peer support boost opioid treatment success?
NCT ID NCT05363371
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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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
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About 240 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2022
- Expected to finish
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May 2027
An estimate. End dates often move.
- Lead sponsor
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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
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19 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
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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
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Birmingham Veteran Affairs Medical Center
Birmingham, Alabama, 35233, United States
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Pathway Healthcare, LLC
Birmingham, Alabama, 35235, United States
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Tuscaloosa Veteran Affairs Medical Center
Tuscaloosa, Alabama, 35404, United States
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University of Alabama
Tuscaloosa, Alabama, 35487, United States
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Other studies related to the condition(s) this trial covers.
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