Substance-related DisordersMBRP-WNCT02977988
Women's Treatment and Early Recovery
A study testing Mindfulness Meditation and Brain and Recovery (B&R) in people with Substance-related Disorders, run by University of Southern California at 1 site in United States.
Trial summary
Approximately 25 million Americans struggle with alcohol or drug problems annually. Abuse of alcohol and drugs is costly to our nation, exacting more than $428 billion in costs related to crime, lost work productivity and health care. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Substance-related Disorders
- What is being tested?
- Mindfulness Meditation and Brain and Recovery (B&R)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2015to 30 Jun 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female
- Adult in California (18 years or older)
- Diagnosed with a substance use disorder (SUD)
- Speaks fluent English
- Client at study site, substance use disorder residential facility at time of recruitment
Who cannot join
- Inability to comprehend informed consent
- Unwilling to sign informed consent
- Cognitive impairment, psychotic disorder or severe chronic mental health condition based on clinical intake DSM-V assessment
- Older than 65 years of age
- Reported suicidality in last 30 days
- Current prisoner
Show all 21Show fewer
- Pregnant in the 3rd trimester
- Pregnant (MRI subsample only)
- Not willing to be audio recorded
- Not willing to have data stored for research purposes
- Additional exclusion criteria for brain imaging sub-study:
- Older than 50 years of age
- Not in good general health
- Left handed (with a mean item score >1 on the handedness scale)
- Currently pregnant
- Current medical devices (cardiac pacemaker, implanted cardiac defibrillator, carotid artery vascular clamp, neurostimulator, cochlear implant, metal fragments (including shrapnel) in the head, eyes, or skin, vascular stent, ocular implant, penile implant, vascular filter for clots (including Greenfield, Umbrella, or Birds Nest filters)
- Other non-removable devices (IUD, dental braces or retainer, piercings that cannot be removed prior to resting, permanent eye-liner)
- Body Mass Index (BMI) greater than 36
- History of head trauma resulting in loss of consciousness for more than 5 minutes
- Documented or subjectively reported claustrophobia
- Having hair extensions or a wig connected by wire
Trial locations and contacts
1 site in 1 country.
United States1 site
Prototypes' Pomona Women's Center
Pomona, California, 91767
About this study
Official title: Neural Mechanisms in Women's Treatment and Early Recovery
Approximately 25 million Americans struggle with alcohol or drug problems annually. Abuse of alcohol and drugs is costly to our nation, exacting more than $428 billion in costs related to crime, lost work productivity and health care. While effective treatments exist, over half of those who enter treatment for substance use disorders drop out early in treatment and return to alcohol or drug abuse. Psychological stress is a causal factor in the pathogenesis of substance use disorder (SUD) and relapse risk. Low-income women report high levels of stress in SUD residential treatment stemming from significant economic and family stressors in addition to challenges of adjusting to residential treatment demands. Unmanaged stress, especially in early stages of residential treatment, is a major concern because it can increase dropout. Dropout from residential treatment places women at risk of substance use relapse. A gap in knowledge persists regarding the use of mindfulness-based interventions with racially/ethnically diverse low-income women with SUDs, especially regarding the efficacy of adapted (Mindfulness-based interventions) MBIs for preventing residential dropout and decreasing relapse. We have fully adapted, developed, and pilot tested a novel MBI, Moment-by-Moment in Women's Recovery: Mindfulness Based Relapse Prevention for Women (MBRP-W), that supports the needs of women in residential treatment. This MBI integrates relapse prevention, addresses literacy level, and is relevant to issues surrounding treatment- and relapse-related stressors of disadvantaged women. The current project has three specific aims: (1) to test the efficacy of MBRP-W on residential treatment retention and substance use relapse in racially/ethnically diverse low-income women; (2) to determine the mechanisms of change underlying the MBRP-W program; and (3) to explore neural changes associated with program effects. A rationale for MBRP-W is the need for self-initiated stress management skills in women with SUDs during the early stressful periods of residential treatment that increase risk of dropout and relapse.
Read the detailed description
- This randomized clinical trial will deliver two interventions as add-ons to residential substance use disorder (SUD) treatment: (1) Moment-by-Moment in women's Recovery: Mindfulness-Based Approach to Relapse Prevention (MBRP-W) and (2) Brain and Recovery (B\&R) which serves as an active psychoeducational attention control group.
- Participants (N=165) who meet study eligibility criteria based on intake assessment will be recruited and complete baseline assessments during weeks 3-6 after entry into a residential treatment program. Participants will be randomly assigned to interventions using Urn randomization. All participants (MBRP-W and B\&R) will receive SUD treatment as normally provided by the treatment program. Fifteen participants from each intervention group (N=30) will be selected to participate in a brain imaging (MRI and fMRI) substudy.
- Participants will be adult females who have been admitted to a residential treatment center in an urban area of California and who are diagnosed with a SUD based on clinical intake Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-V) diagnostic assessment.
- MBRP-W is delivered in 12 bi-weekly 80-minute group sessions with SUD clinical populations. Facilitators will have previous experience in MBSR facilitation and will be trained in MBRP-W. Each session has a central theme and is divided into five segments consisting of (a) a welcome meditation or other mindfulness practice, (b) a review of session objectives, (c) a brief didactic psycho-educational presentation and discussion based on the session's theme, (d) experiential and formal meditation or other practices, and (e) readings and practice assignments for the next class.
- B\&R is delivered in 12 bi-weekly 80-minute group sessions with SUD clinical populations. Facilitators will be trained in B\&R. The B\&R group will receive didactic education on the neurobiology of addiction. B\&R contains no information on behavior change, relapse prevention, stress reduction, or mindfulness-based or relapse-related content. The intervention was developed over three years with a population similar to that of the current study (i.e., racially/ethnically diverse and low-income women in SUD treatment) with input and review from focus group participants, care providers in SUD treatment, and three experts on the neurobiology of addiction. Topics include: (1) brain structure and function related to addiction, (2) effects of various types of substance use on the brain, and (3) rewarding effects of substance use and how these rewarding effects can lead to addiction.
- There are three data collection points, 1) baseline, 2) immediate post-intervention, and 3) 8-months post-intervention completion. Data will be collected in-person by research interviewers via computer-assisted interviews, which includes administration of an alcohol Breathalyzer test to assess alcohol use and collection of a urine sample to assess drug use. Interviews will be conducted at the treatment program (for those who remain in residential treatment) or at convenient locations for participants no longer in treatment. Baseline interview will occur prior to randomization, post-intervention interview will occur within 1-2 weeks of the last group session, and the follow-up interview will occur at an 8-months post-intervention completion window. Brain imaging for a subsample of participants will be completed at baseline and immediate post-intervention.
- Number of intervention program class sessions attended will be collected for all enrolled participants.
- Participant Satisfaction Surveys measuring acceptability, credibility, and perceived utility of the study arms will be administered to both groups at two class sessions.
- Applied Mindfulness Practice Scale (AMPS) measuring the participant's application of mindfulness skills to address life challenges, will be administered to the MBRP-W participants at four class sessions as well as at follow-up. Mindfulness practice effort will also be assessed at these same four class sessions.
- An in-treatment clinical record review of services will be collected weekly for the duration of residential treatment.
- Conditions
- Substance-related Disorders
- Being tested
- Mindfulness Meditation, Brain and Recovery (B&R)
- Keywords
- Mindfulness, Women, Relapse prevention, Clinical trial, Substance use disorder, Ethnically diverse, Underserved, Health disparities, Stress, Addiction, Latina/Hispanic, African American, Treatment retention, Residential treatment, Brain Imaging
- Medical subject headings
- Substance-Related Disorders, Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness MeditationBehavioural
Also called Mindfulness-Based Relapse Prevention-Women (MBRP-W)
MBRP-W is delivered in 12 bi-weekly 80-minute group sessions. Facilitators with previous experience in MBSR and trained in MBRP-W will deliver each group. Each session has a central theme and is divided into five segments consisting of: (a) a welcome meditation or other mindfulness practice, (b) a review of session objectives, (c) a brief didactic psycho-educational presentation and discussion based on the session's theme, (d) experiential and formal meditation or other practices, and (e) readings and assignments for the next class. Participants are expected to learn skill building techniques to reducing stress using mindfulness-based principles to complement their recovery treatment program.
Brain and Recovery (B&R)Behavioural
B\&R is delivered in 12 bi-weekly 80-minute group sessions delivered by two trained interventionists. The B\&R group will receive didactic education on the neurobiology of addiction. B\&R contains no information on behavior change, stress reduction, or mindfulness-based or relapse-related content. The intervention was developed over three years with a population similar to those in the study and with input from patients and experts on neurobiology of addiction. Topics include: (1) brain structures and functions related to addiction, (2) effects of various types of substances on the brain, and (3) rewarding effects and how these lead to addiction. Participants are expected to gain knowledge pertaining to the effects of drugs on the brain.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness Meditation | Experimental | Mindfulness-Based Relapse Prevention-Women (MBRP-W) Receives: Behavioral: Mindfulness Meditation |
| Active Comparator | Active comparator | Brain and Recovery (B\&R) Receives: Behavioral: Brain and Recovery (B&R) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Completion
Number of women being designated by the site clinic as a completer during a discharge event.
Measured: 5 month follow period
Days of Any Drug Use
Days of any drug use to include multiple drug types from study intervention end date to follow-up
Measured: 8.5 months
Secondary outcomes (1)
Psychological Symptoms
Five Facet Mindfulness Questionnaire (FFMQ): higher scores indicate better mindfulness qualities (better outcome).
Perceived Stress Scale (PSS): higher scores indicate greater perceived stress (worse outcome).
Depression Anxiety Stress Scale (DASS): higher scores indicate greater depression, anxiety, and stress (worse outcome).
Distress Tolerance Scale (DTS): higher scores indicate greater distress tolerance (better outcome).
Difficulties in Emotion Regulation Scale (DERS): higher scores indicate greater difficulties in emotion regulation (worse outcome).
Penn Craving Scale (PCS): higher scores indicate greater craving (worse outcome).
Positive and Negative Affect Schedule (PANAS) - Negative Affect subscale: higher scores indicate greater negative affect (worse outcome).
Minimum and maximum values are not standardized.
Measured: 8.5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2016 (estimated)
- Study start15 Oct 2015
- Primary completion17 Aug 2018
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Substance-related DisordersStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, David S Black, PhD, University of Southern California
- Investigators
- David S Black, PhD, MPH, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02977988
- Sponsor's protocol ID
- UP-14-00391-AM001
- Other IDs
- 5R01DA038648-04
- Acronym
- MBRP-W
- Status last verified
- Jan 2026
- First submitted
- 28 Nov 2016
- Last updated
- 13 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: Not until 12 months after final outcomes manuscript is submitted for publication. Contact davidbla@usc.edu for dataset
Publications
Amaro H, Spear S, Vallejo Z, Conron K, Black DS. Feasibility, acceptability, and preliminary outcomes of a mindfulness-based relapse prevention intervention for culturally-diverse, low-income women in substance use disorder treatment. Subst Use Misuse. 2014 Apr;49(5):547-59. doi: 10.3109/10826084.2013.852587.
PubMed 24611850Black DS, O'Reilly GA, Olmstead R, Breen EC, Irwin MR. Mindfulness-based intervention for prodromal sleep disturbances in older adults: design and methodology of a randomized controlled trial. Contemp Clin Trials. 2014 Sep;39(1):22-7. doi: 10.1016/j.cct.2014.06.013. Epub 2014 Jul 1.
PubMed 24993561Hanley A, Garland EL, Black DS. Use of mindful reappraisal coping among meditation practitioners. J Clin Psychol. 2014 Mar;70(3):294-301. doi: 10.1002/jclp.22023. Epub 2013 Jul 1.
PubMed 23818289Li MJ, Black DS, Garland EL. The Applied Mindfulness Process Scale (AMPS): A process measure for evaluating mindfulness-based interventions. Pers Individ Dif. 2016 Apr 1;93:6-15. doi: 10.1016/j.paid.2015.10.027.
PubMed 26858469Black DS, Slavich GM. Mindfulness meditation and the immune system: a systematic review of randomized controlled trials. Ann N Y Acad Sci. 2016 Jun;1373(1):13-24. doi: 10.1111/nyas.12998. Epub 2016 Jan 21.
PubMed 26799456Galla BM, O'Reilly GA, Kitil MJ, Smalley SL, Black DS. Community-Based Mindfulness Program for Disease Prevention and Health Promotion: Targeting Stress Reduction. Am J Health Promot. 2015 Sep-Oct;30(1):36-41. doi: 10.4278/ajhp.131107-QUAN-567. Epub 2014 Aug 27.
PubMed 25162319Garland EL, Black DS. Mindfulness for chronic pain and prescription opioid misuse: novel mechanisms and unresolved issues. Subst Use Misuse. 2014 Apr;49(5):608-11. doi: 10.3109/10826084.2014.852801. No abstract available.
PubMed 24611857Peltz L, Black DS. The thinking mind as addiction: mindfulness as antidote. Subst Use Misuse. 2014 Apr;49(5):605-7. doi: 10.3109/10826084.2014.852803. No abstract available.
PubMed 24611856Witkiewitz K, Black DS. Unresolved issues in the application of mindfulness-based interventions for substance use disorders. Subst Use Misuse. 2014 Apr;49(5):601-4. doi: 10.3109/10826084.2014.852797. No abstract available.
PubMed 24611855Black DS. Mindfulness-based interventions: an antidote to suffering in the context of substance use, misuse, and addiction. Subst Use Misuse. 2014 Apr;49(5):487-91. doi: 10.3109/10826084.2014.860749.
PubMed 24611846Black DS. Mindfulness and substance use intervention. Subst Use Misuse. 2012 Feb;47(3):199-201. doi: 10.3109/10826084.2011.635461. No abstract available.
PubMed 22217122Amaro H, Black DS. Mindfulness-Based Intervention Effects on Substance Use and Relapse Among Women in Residential Treatment: A Randomized Controlled Trial With 8.5-Month Follow-Up Period From the Moment-by-Moment in Women's Recovery Project. Psychosom Med. 2021 Jul-Aug 01;83(6):528-538. doi: 10.1097/PSY.0000000000000907.
PubMed 34213858Amaro H, Black DS. Moment-by-Moment in Women's Recovery: Randomized controlled trial protocol to test the efficacy of a mindfulness-based intervention on treatment retention and relapse prevention among women in residential treatment for substance use disorder. Contemp Clin Trials. 2017 Nov;62:146-152. doi: 10.1016/j.cct.2017.09.004. Epub 2017 Sep 14.
PubMed 28918120Black DS, Amaro H. Moment-by-Moment in Women's Recovery (MMWR): Mindfulness-based intervention effects on residential substance use disorder treatment retention in a randomized controlled trial. Behav Res Ther. 2019 Sep;120:103437. doi: 10.1016/j.brat.2019.103437. Epub 2019 Jul 7.
PubMed 31419610Kechter A, Amaro H, Black DS. Reporting of Treatment Fidelity in Mindfulness-Based Intervention Trials: A Review and New Tool using NIH Behavior Change Consortium Guidelines. Mindfulness (N Y). 2019 Feb;10(2):215-233. doi: 10.1007/s12671-018-0974-4. Epub 2018 Jun 22.
PubMed 30854147
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neural Mechanisms in Women's Treatment and Early Recovery
- ClinicalTrials.gov ID
- NCT02977988
- Acronym / sponsor ID
- MBRP-W / UP-14-00391-AM001
- Conditions
- Substance-related Disorders
- Keywords
- Mindfulness, Women, Relapse prevention, Clinical trial, Substance use disorder, Ethnically diverse, Underserved, Health disparities
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 15 Oct 2015 (actual)
- Primary completion
- 17 Aug 2018 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 30 Nov 2016 (estimated)
- Results
- Posted 13 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Approximately 25 million Americans struggle with alcohol or drug problems annually. Abuse of alcohol and drugs is costly to our nation, exacting more than $428 billion in costs related to crime, lost work productivity and health care. While effective treatments exist, over half of those who enter treatment for substance use disorders drop out early in treatment and return to alcohol or drug abuse. Psychological stress is a causal factor in the pathogenesis of substance use disorder (SUD) and relapse risk. Low-income women report high levels of stress in SUD residential treatment stemming from significant economic and family stressors in addition to challenges of adjusting to residential treatment demands. Unmanaged stress, especially in early stages of residential treatment, is a major concern because it can increase dropout. Dropout from residential treatment places women at risk of substance use relapse. A gap in knowledge persists regarding the use of mindfulness-based interventions with racially/ethnically diverse low-income women with SUDs, especially regarding the efficacy of adapted (Mindfulness-based interventions) MBIs for preventing residential dropout and decreasing relapse. We have fully adapted, developed, and pilot tested a novel MBI, Moment-by-Moment in Women's Recovery: Mindfulness Based Relapse Prevention for Women (MBRP-W), that supports the needs of women in residential treatment. This MBI integrates relapse prevention, addresses literacy level, and is relevant to issues surrounding treatment- and relapse-related stressors of disadvantaged women. The current project has three specific aims: (1) to test the efficacy of MBRP-W on residential treatment retention and substance use relapse in racially/ethnically diverse low-income women; (2) to determine the mechanisms of change underlying the MBRP-W program; and (3) to explore neural changes associated with program effects. A rationale for MBRP-W is the need for self-initiated stress management skills in women with SUDs during the early stressful periods of residential treatment that increase risk of dropout and relapse.
Detailed description
- This randomized clinical trial will deliver two interventions as add-ons to residential substance use disorder (SUD) treatment: (1) Moment-by-Moment in women's Recovery: Mindfulness-Based Approach to Relapse Prevention (MBRP-W) and (2) Brain and Recovery (B\&R) which serves as an active psychoeducational attention control group.
- Participants (N=165) who meet study eligibility criteria based on intake assessment will be recruited and complete baseline assessments during weeks 3-6 after entry into a residential treatment program. Participants will be randomly assigned to interventions using Urn randomization. All participants (MBRP-W and B\&R) will receive SUD treatment as normally provided by the treatment program. Fifteen participants from each intervention group (N=30) will be selected to participate in a brain imaging (MRI and fMRI) substudy.
- Participants will be adult females who have been admitted to a residential treatment center in an urban area of California and who are diagnosed with a SUD based on clinical intake Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-V) diagnostic assessment.
- MBRP-W is delivered in 12 bi-weekly 80-minute group sessions with SUD clinical populations. Facilitators will have previous experience in MBSR facilitation and will be trained in MBRP-W. Each session has a central theme and is divided into five segments consisting of (a) a welcome meditation or other mindfulness practice, (b) a review of session objectives, (c) a brief didactic psycho-educational presentation and discussion based on the session's theme, (d) experiential and formal meditation or other practices, and (e) readings and practice assignments for the next class.
- B\&R is delivered in 12 bi-weekly 80-minute group sessions with SUD clinical populations. Facilitators will be trained in B\&R. The B\&R group will receive didactic education on the neurobiology of addiction. B\&R contains no information on behavior change, relapse prevention, stress reduction, or mindfulness-based or relapse-related content. The intervention was developed over three years with a population similar to that of the current study (i.e., racially/ethnically diverse and low-income women in SUD treatment) with input and review from focus group participants, care providers in SUD treatment, and three experts on the neurobiology of addiction. Topics include: (1) brain structure and function related to addiction, (2) effects of various types of substance use on the brain, and (3) rewarding effects of substance use and how these rewarding effects can lead to addiction.
- There are three data collection points, 1) baseline, 2) immediate post-intervention, and 3) 8-months post-intervention completion. Data will be collected in-person by research interviewers via computer-assisted interviews, which includes administration of an alcohol Breathalyzer test to assess alcohol use and collection of a urine sample to assess drug use. Interviews will be conducted at the treatment program (for those who remain in residential treatment) or at convenient locations for participants no longer in treatment. Baseline interview will occur prior to randomization, post-intervention interview will occur within 1-2 weeks of the last group session, and the follow-up interview will occur at an 8-months post-intervention completion window. Brain imaging for a subsample of participants will be completed at baseline and immediate post-intervention.
- Number of intervention program class sessions attended will be collected for all enrolled participants.
- Participant Satisfaction Surveys measuring acceptability, credibility, and perceived utility of the study arms will be administered to both groups at two class sessions.
- Applied Mindfulness Practice Scale (AMPS) measuring the participant's application of mindfulness skills to address life challenges, will be administered to the MBRP-W participants at four class sessions as well as at follow-up. Mindfulness practice effort will also be assessed at these same four class sessions.
- An in-treatment clinical record review of services will be collected weekly for the duration of residential treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness Meditation | Experimental | Behavioral: Mindfulness MeditationMindfulness-Based Relapse Prevention-Women (MBRP-W) |
| Active Comparator | Active comparator | Behavioral: Brain and Recovery (B&R)Brain and Recovery (B\&R) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Female
- Adult in California (18 years or older)
- Diagnosed with a substance use disorder (SUD)
- Speaks fluent English
- Client at study site, substance use disorder residential facility at time of recruitment
Key exclusion criteria (21 listed)
- Inability to comprehend informed consent
- Unwilling to sign informed consent
- Cognitive impairment, psychotic disorder or severe chronic mental health condition based on clinical intake DSM-V assessment
- Older than 65 years of age
- Reported suicidality in last 30 days
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 MeditationAlso: Mindfulness-Based Relapse Prevention-Women (MBRP-W)MBRP-W is delivered in 12 bi-weekly 80-minute group sessions. Facilitators with previous experience in MBSR and trained in MBRP-W will deliver each group. Each session has a central theme and is divided into five segments consisting of: (a) a welcome meditation or other mindfulness practice, (b) a review of session objectives, (c) a brief didactic psycho-educational presentation and discussion based on the session's theme, (d) experiential and formal meditation or other practices, and (e) readings and assignments for the next class. Participants are expected to learn skill building techniques to reducing stress using mindfulness-based principles to complement their recovery treatment program. | Behavioural | Mindfulness Meditation |
| Brain and Recovery (B&R)B\&R is delivered in 12 bi-weekly 80-minute group sessions delivered by two trained interventionists. The B\&R group will receive didactic education on the neurobiology of addiction. B\&R contains no information on behavior change, stress reduction, or mindfulness-based or relapse-related content. The intervention was developed over three years with a population similar to those in the study and with input from patients and experts on neurobiology of addiction. Topics include: (1) brain structures and functions related to addiction, (2) effects of various types of substances on the brain, and (3) rewarding effects and how these lead to addiction. Participants are expected to gain knowledge pertaining to the effects of drugs on the brain. | Behavioural | Active Comparator |
Primary outcome
Treatment Completion
Time frame: 5 month follow period
Number of women being designated by the site clinic as a completer during a discharge event.
Days of Any Drug Use
Time frame: 8.5 months
Days of any drug use to include multiple drug types from study intervention end date to follow-up
1 secondary outcome
Psychological Symptoms
Time frame: 8.5 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 24611850Amaro H, Spear S, Vallejo Z, Conron K, Black DS. Feasibility, acceptability, and preliminary outcomes of a mindfulness-based relapse prevention intervention for culturally-diverse, low-income women in substance use disorder treatment. Subst Use Misuse. 2014 Apr;49(5):547-59. doi: 10.3109/10826084.2013.852587.
- Background: PubMed 24993561Black DS, O'Reilly GA, Olmstead R, Breen EC, Irwin MR. Mindfulness-based intervention for prodromal sleep disturbances in older adults: design and methodology of a randomized controlled trial. Contemp Clin Trials. 2014 Sep;39(1):22-7. doi: 10.1016/j.cct.2014.06.013. Epub 2014 Jul 1.
- Background: PubMed 23818289Hanley A, Garland EL, Black DS. Use of mindful reappraisal coping among meditation practitioners. J Clin Psychol. 2014 Mar;70(3):294-301. doi: 10.1002/jclp.22023. Epub 2013 Jul 1.
- Background: PubMed 26858469Li MJ, Black DS, Garland EL. The Applied Mindfulness Process Scale (AMPS): A process measure for evaluating mindfulness-based interventions. Pers Individ Dif. 2016 Apr 1;93:6-15. doi: 10.1016/j.paid.2015.10.027.
- Background: PubMed 26799456Black DS, Slavich GM. Mindfulness meditation and the immune system: a systematic review of randomized controlled trials. Ann N Y Acad Sci. 2016 Jun;1373(1):13-24. doi: 10.1111/nyas.12998. Epub 2016 Jan 21.
- Background: PubMed 25162319Galla BM, O'Reilly GA, Kitil MJ, Smalley SL, Black DS. Community-Based Mindfulness Program for Disease Prevention and Health Promotion: Targeting Stress Reduction. Am J Health Promot. 2015 Sep-Oct;30(1):36-41. doi: 10.4278/ajhp.131107-QUAN-567. Epub 2014 Aug 27.
- Background: PubMed 24611857Garland EL, Black DS. Mindfulness for chronic pain and prescription opioid misuse: novel mechanisms and unresolved issues. Subst Use Misuse. 2014 Apr;49(5):608-11. doi: 10.3109/10826084.2014.852801. No abstract available.
- Background: PubMed 24611856Peltz L, Black DS. The thinking mind as addiction: mindfulness as antidote. Subst Use Misuse. 2014 Apr;49(5):605-7. doi: 10.3109/10826084.2014.852803. No abstract available.
- Background: PubMed 24611855Witkiewitz K, Black DS. Unresolved issues in the application of mindfulness-based interventions for substance use disorders. Subst Use Misuse. 2014 Apr;49(5):601-4. doi: 10.3109/10826084.2014.852797. No abstract available.
- Background: PubMed 24611846Black DS. Mindfulness-based interventions: an antidote to suffering in the context of substance use, misuse, and addiction. Subst Use Misuse. 2014 Apr;49(5):487-91. doi: 10.3109/10826084.2014.860749.
- Background: PubMed 22217122Black DS. Mindfulness and substance use intervention. Subst Use Misuse. 2012 Feb;47(3):199-201. doi: 10.3109/10826084.2011.635461. No abstract available.
- Background: PubMed 34213858Amaro H, Black DS. Mindfulness-Based Intervention Effects on Substance Use and Relapse Among Women in Residential Treatment: A Randomized Controlled Trial With 8.5-Month Follow-Up Period From the Moment-by-Moment in Women's Recovery Project. Psychosom Med. 2021 Jul-Aug 01;83(6):528-538. doi: 10.1097/PSY.0000000000000907.
- American Mindfulness Research AssociationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Not until 12 months after final outcomes manuscript is submitted for publication. Contact davidbla@usc.edu for dataset
Related trials for Substance-related Disorders
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Enrolling by invitationObservational study
Development of an Interview-Informed Timeline Follow-Back (TLFB) for Opioid Use in the Era of Fentanyl
Substance Use Disorders (SUDs)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
Not yet recruiting
Substance Use and Media Preferences
Substance Use Behavior, Cannabis Intoxication
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.
David S Black, PhD, MPH principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness Meditation and Brain and Recovery (B&R) in people with Substance-related Disorders, run by University of Southern California 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 21 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 13 Jan 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?
Yes. Results are posted in the registry (first posted 13 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Treatment Completion (time frame: 5 month follow period). The study lists 2 primary outcomes in all. 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 NCT02977988, which also lists 16 linked publications.
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 13 Jan 2026.