Substance Use DisordersMBRP-SUDNCT07417579
Mindfulness and Meditation-Based Relapse Prevention for Substance Use Disorders
An observational study of Substance Use Disorders and Behavioral Health, run by Bout Me Healing at 1 site in United States.
Trial summary
Mindfulness and meditation based relapse prevention has been proposed as an adjunctive approach for individuals with substance use disorders (SUDs). This completed pilot observational case series describes outcomes from three de-identified participants who completed an eight-week mindfulness and meditation program… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Substance Use Disorders, Behavioral Health, Addiction Psychological
- What is being tested?
- Mindfulness and Meditation-Based Relapse Prevention Program
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2015to 11 Mar 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Observational Case Series of Mindfulness- and Meditation-Based Relapse Prevention for Substance Use Disorders (MBRP-SUD)
Mindfulness and meditation based relapse prevention has been proposed as an adjunctive approach for individuals with substance use disorders (SUDs). This completed pilot observational case series describes outcomes from three de-identified participants who completed an eight-week mindfulness and meditation program designed to reduce stress, enhance coping skills, and support sustained recovery.
Participants demonstrated improvements in perceived stress and mindfulness following the intervention. Two participants experienced relapse within 10-12 months, while one participant maintained long-term sobriety. This small case series provides descriptive clinical insights and supports the feasibility of mindfulness-based interventions in real-world treatment settings.
Read the detailed description
This pilot observational case series evaluated an eight-week mindfulness and meditation-based relapse prevention program delivered to three de-identified adults with substance use disorders. The intervention included weekly guided mindfulness sessions, daily home practice, and group discussions focused on awareness of cravings, emotional regulation, and relapse prevention strategies.
Outcomes were assessed using self-reported perceived stress and mindfulness measures, along with qualitative clinical interviews and participant journals to monitor relapse behavior. All participants demonstrated improvements in perceived stress and mindfulness. Relapse occurred in two participants within one year, while one participant maintained long-term sobriety.
This study was exploratory and descriptive in nature, with a small sample size. Ethics review was not required as all participants were de-identified and the study was conducted as a clinical case series. Findings are intended to inform future research and larger-scale studies of mindfulness-based relapse prevention interventions.
- Conditions
- Substance Use Disorders, Behavioral Health, Addiction Psychological, Addiction Disorders, Meditation, Mindfulness Based Stress Reduction
- Being tested
- Mindfulness and Meditation-Based Relapse Prevention Program
- Keywords
- mindfulness, meditation, relapse prevention, substance use, behavioral health, addiction recovery
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness and Meditation-Based Relapse Prevention ProgramBehavioural
The mindfulness and meditation-based relapse prevention program consisted of an eight-week structured intervention delivered as part of routine clinical practice. Participants engaged in weekly guided mindfulness meditation sessions, daily individual home practice, and facilitated group discussions. The intervention focused on developing awareness of thoughts, emotions, cravings, and stress responses, with an emphasis on nonjudgmental observation and emotional regulation. Sessions included mindfulness exercises, breathing techniques, body awareness practices, and reflective discussion related to relapse prevention and coping strategies. The program was not designed as a randomized or controlled intervention and was implemented uniformly across participants.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness-Based Relapse Prevention Case Series | This cohort includes three adult participants with histories of substance use disorders who completed an eight-week mindfulness and meditation-based relapse prevention program delivered as part of routine clinical practice. Participants engaged in guided mindfulness meditation sessions, daily home practice, and group discussions focused on stress awareness, emotional regulation, craving management, and relapse prevention skills. Outcomes were assessed descriptively using self-reported stress and mindfulness measures, participant journals, and clinical interviews. Receives: Behavioral: Mindfulness and Meditation-Based Relapse Prevention Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Perceived Stress and Mindfulness Following Mindfulness-Based Relapse Prevention Program
The primary outcome is the change in perceived stress and mindfulness levels in participants completing an eight-week mindfulness and meditation-based relapse prevention program. Stress was assessed using the Perceived Stress Scale and mindfulness using the Five Facet Mindfulness Questionnaire. Observations were collected through participant journals and clinical interviews, comparing baseline to post-intervention outcomes. This outcome reflects the feasibility and potential impact of mindfulness-based practices in supporting emotional regulation and coping strategies for individuals with substance use disorders.
Measured: Baseline (pre-intervention) to end of the eight-week program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2026
- Study start15 Jan 2015
- Primary completion11 Mar 2015
- Study completion11 Mar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Substance Use DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bout Me Healing
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Cice Rivera, Bout Me Healing
- Investigators
- Cice Rivera, MS, CAP, Principal investigator, Bout Me Healing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07417579
- Sponsor's protocol ID
- BMH-MBRP-OBS-001
- Acronym
- MBRP-SUD
- Status last verified
- Feb 2026
- First submitted
- 11 Feb 2026
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (IPD) from this study, including de-identified perceived stress scores, mindfulness scores, and relapse observations, will be made available upon reasonable request to qualified researchers. All data will be fully de-identified to protect participant privacy. Data requests should include a research proposal and data use agreement. The data will be available for three years following publication of the study results. The study dataset is small (three participants) and observational in nature; requests will be reviewed to ensure ethical use and protection of participant confidentiality.
Publications
Rivera, Cice (2026). Mindfulness and Meditation-Based Relapse Prevention for Substance Use Disorders: Research Case Series of Three Participants. figshare. Journal contribution. https://doi.org/10.6084/m9.figshare.31302370.v1
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Case Series of Mindfulness- and Meditation-Based Relapse Prevention for Substance Use Disorders (MBRP-SUD)
- ClinicalTrials.gov ID
- NCT07417579
- Acronym / sponsor ID
- MBRP-SUD / BMH-MBRP-OBS-001
- Conditions
- Substance Use Disorders, Behavioral Health, Addiction Psychological, Addiction Disorders, Meditation, Mindfulness Based Stress Reduction
- Keywords
- mindfulness, meditation, relapse prevention, substance use, behavioral health, addiction recovery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Bout Me HealingIndustry (pharma, biotech, devices)
- Study start
- 15 Jan 2015 (actual)
- Primary completion
- 11 Mar 2015 (actual)
- Study completion
- 11 Mar 2016 (actual)
- First posted
- 18 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Mindfulness and meditation based relapse prevention has been proposed as an adjunctive approach for individuals with substance use disorders (SUDs). This completed pilot observational case series describes outcomes from three de-identified participants who completed an eight-week mindfulness and meditation program designed to reduce stress, enhance coping skills, and support sustained recovery.
Participants demonstrated improvements in perceived stress and mindfulness following the intervention. Two participants experienced relapse within 10-12 months, while one participant maintained long-term sobriety. This small case series provides descriptive clinical insights and supports the feasibility of mindfulness-based interventions in real-world treatment settings.
Detailed description
This pilot observational case series evaluated an eight-week mindfulness and meditation-based relapse prevention program delivered to three de-identified adults with substance use disorders. The intervention included weekly guided mindfulness sessions, daily home practice, and group discussions focused on awareness of cravings, emotional regulation, and relapse prevention strategies.
Outcomes were assessed using self-reported perceived stress and mindfulness measures, along with qualitative clinical interviews and participant journals to monitor relapse behavior. All participants demonstrated improvements in perceived stress and mindfulness. Relapse occurred in two participants within one year, while one participant maintained long-term sobriety.
This study was exploratory and descriptive in nature, with a small sample size. Ethics review was not required as all participants were de-identified and the study was conducted as a clinical case series. Findings are intended to inform future research and larger-scale studies of mindfulness-based relapse prevention interventions.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-Based Relapse Prevention Case Series | – | Behavioral: Mindfulness and Meditation-Based Relapse Prevention ProgramThis cohort includes three adult participants with histories of substance use disorders who completed an eight-week mindfulness and meditation-based relapse prevention program delivered as part of routine clinical practice. Participants engaged in guided mindfulness meditation sessions, daily home practice, and group discussions focused on stress awareness, emotional regulation, craving management, and relapse prevention skills. Outcomes were assessed descriptively using self-reported stress and mindfulness measures, participant journals, and clinical interviews. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness and Meditation-Based Relapse Prevention ProgramThe mindfulness and meditation-based relapse prevention program consisted of an eight-week structured intervention delivered as part of routine clinical practice. Participants engaged in weekly guided mindfulness meditation sessions, daily individual home practice, and facilitated group discussions. The intervention focused on developing awareness of thoughts, emotions, cravings, and stress responses, with an emphasis on nonjudgmental observation and emotional regulation. Sessions included mindfulness exercises, breathing techniques, body awareness practices, and reflective discussion related to relapse prevention and coping strategies. The program was not designed as a randomized or controlled intervention and was implemented uniformly across participants. | Behavioural | Mindfulness-Based Relapse Prevention Case Series |
Primary outcome
Change in Perceived Stress and Mindfulness Following Mindfulness-Based Relapse Prevention Program
Time frame: Baseline (pre-intervention) to end of the eight-week program
The primary outcome is the change in perceived stress and mindfulness levels in participants completing an eight-week mindfulness and meditation-based relapse prevention program. Stress was assessed using the Perceived Stress Scale and mindfulness using the Five Facet Mindfulness Questionnaire. Observations were collected through participant journals and clinical interviews, comparing baseline to post-intervention outcomes. This outcome reflects the feasibility and potential impact of mindfulness-based practices in supporting emotional regulation and coping strategies for individuals with substance use disorders.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2026.
- Results publicationRivera, Cice (2026). Mindfulness and Meditation-Based Relapse Prevention for Substance Use Disorders: Research Case Series of Three Participants. figshare. Journal contribution. https://doi.org/10.6084/m9.figshare.31302370.v1
- De-identified participant data, study protocol, and clinical report will be shared with qualified researchers upon request for 3 years following publication.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Individual participant data (IPD) from this study, including de-identified perceived stress scores, mindfulness scores, and relapse observations, will be made available upon reasonable request to qualified researchers. All data will be fully de-identified to protect participant privacy. Data requests should include a research proposal and data use agreement. The data will be available for three years following publication of the study results. The study dataset is small (three participants) and observational in nature; requests will be reviewed to ensure ethical use and protection of participant confidentiality.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cice Rivera, MS, CAP principal investigator
Bout Me Healing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Substance Use Disorders and Behavioral Health, run by Bout Me Healing at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Perceived Stress and Mindfulness Following Mindfulness-Based Relapse Prevention Program (time frame: Baseline (pre-intervention) to end of the eight-week program). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07417579, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2026; AzTrials last refreshed its copy on 26 Oct 2026.