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Mindfulness program shows promise in preventing relapse, but tiny study limits conclusions

NCT ID NCT07417579

Prevention Sponsor: Bout Me Healing 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This small pilot study tested an 8-week mindfulness and meditation program in 3 adults with substance use disorders. Participants reported lower stress and improved mindfulness after the program. One person stayed sober long-term, while two relapsed within a year. The study shows the approach is feasible but too small to draw firm conclusions.

What this could mean

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

Active substance
Mindfulness and meditation-based relapse prevention program (behavioral intervention)
What this could lead to
If this approach works in larger studies, it could offer a low-cost, non-drug tool to help people with substance use disorders maintain recovery and reduce relapse.
What could go wrong
This was a very small pilot with only 3 participants, and two of them relapsed within a year. The results are not generalizable, and more research is needed to confirm any benefit.

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.

Participants

3 people

The number who actually took part.

Started

Jan 2015

Finished

Mar 2016

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Who is studied

The study population consisted of three de-identified adults with a history of substance use disorders who participated in an eight-week mindfulness and meditation based relapse prevention program. Participants included two females and one male, ranging in age from 30 to 51 years. All participants engaged in weekly guided sessions, daily home practice, and group discussions. The population was selected from individuals already enrolled in the program and willing to participate in data collection for observational purposes. No restrictions were placed on sex beyond adult eligibility, and participants had varying substance use histories and prior treatment experiences.

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: * Adults aged 18 years or older * History of substance use disorder (any substance) * Enrolled in or referred to an eight-week mindfulness and meditation-based relapse prevention program * Willing and able to participate in weekly guided sessions, daily home practice, and group discussions * Able to provide self-reported information on stress, mindfulness, and relapse experiences Exclusion Criteria: * Individuals under 18 years of age * Inability or unwillingness to participate in mindfulness or meditation exercises * Severe cognitive impairment or psychiatric condition preventing participation in group or home practice * Participation in concurrent structured relapse prevention programs outside of this study

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Conditions

The condition(s) this trial relates to.

mental disorder substance-related disorder

As listed by the trial registrant

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

Addiction disorders Addiction psychological Behavioral health Meditation Mindfulness based stress reduction Prevention Substance use disorders

Contacts and locations

Locations

  • Bout Me Healing

    Boca Raton, Florida, 33496, United States

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