Alcohol AbuseMITNCT03883646
Mindfulness for Alcohol Abusing Offenders
A study testing Mindfulness and Relapse Prevention in people with Alcohol Abuse and Criminal Behavior, run by The Mind Research Network at 1 site in United States.
Trial summary
Over half of state and federal prisoners meet clinical criteria for alcohol abuse or dependence, and after release from prison, over three-quarters of offenders are re-arrested within five years. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Alcohol Abuse, Criminal Behavior
- What is being tested?
- Mindfulness and Relapse Prevention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 392 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2018to 30 Apr 2025
- Phase
- Interventional
- 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 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-65 years of age
- Alcohol Use Disorder
- Female (biological sex at birth)
- Time to release from incarceration > 3 months
- 5th grade or higher reading level
- Able to speak and understand English
Who cannot join
- Uncorrectable auditory or visual deficits
- Intelligence Quotient score below 70
- History of dementia or other cognitive disability
- Current psychotic disorder (chronic schizophrenia or schizoaffective disorder and/or active psychotic symptoms)
- Major medical illness or Central Nervous System disease
- MRI incompatibility (e.g., metal in body)
Trial locations and contacts
1 site in 1 country.
United States1 site
The Mind Research Network
Albuquerque, New Mexico, 87106
About this study
Over half of state and federal prisoners meet clinical criteria for alcohol abuse or dependence, and after release from prison, over three-quarters of offenders are re-arrested within five years. Thus, there is a critical need for more effective interventions that could help disrupt this insidious cycle of alcohol abuse, criminal behavior, and incarceration. This project will support the development and evaluation of a mindfulness intervention for female prison inmates that will target key neuropsychological vulnerabilities that are associated with relapse and recidivism.
Read the detailed description
The pernicious link between substance abuse and criminal behavior imposes major costs to society, totaling billions of dollars in the U.S. annually. There is a critical need for more effective interventions to counteract the high rates of relapse and recidivism in alcohol and substance abusing criminal offenders. Periods of offender incarceration provide a unique opportunity to develop and deploy such interventions. Progress in intervention development could be achieved by targeting specific cognitive and affective vulnerabilities that are common among substance abusing criminal offenders. Preliminary studies suggest that meditative or mindfulness interventions may confer significant psychological and behavioral benefits to inmates. However, the mechanisms and extent of intervention efficacy are unclear, as these previous studies have been beset by a number of methodological limitations. Moreover, to date no study has examined the neurobiological mechanisms that relate to treatment success in this population. NIAAA has recently made a program call to address these issues (PA-15-299). Here we answer this program call and propose to undertake a rigorous and comprehensive longitudinal study of mindfulness treatment of alcohol and substance use disorders among female inmates. This project will randomly assign over 400 female inmates to a mindfulness or relapse prevention training course, and both will be compared against a no treatment control. The mindfulness intervention will be tailored to address two key neuropsychological deficits in alcohol abusing criminal offenders: impulsivity and craving. We will test hypotheses about the neural changes over time with treatment to elucidate mechanisms of change. We will obtain estimates of "real-world" efficacy of the intervention by collecting outcome measures in prison (conduct reports) and following release (alcohol use relapse and antisocial behavior). This project takes advantage of a unique, longstanding partnership between the research team and the states of New Mexico and Wisconsin Correction Departments that allows collection of comprehensive assessment data from inmates during incarceration, including brain imaging data with a mobile MRI scanner, as well as access to post-release outcomes and relapse data. Completion of these aims is a critical step for implementing and evaluating a promising mindfulness intervention for this high-risk population. The proposed research will also begin to elucidate the psychological and neurobiological mechanisms of the treatment. These results will thus significantly advance a program of research seeking to translate the growing knowledge of neuropsychological deficits into more targeted and effective treatments for alcohol and substance abuse problems in criminal offenders.
- Conditions
- Alcohol Abuse, Criminal Behavior
- Being tested
- Mindfulness, Relapse Prevention
- Medical subject headings
- Alcoholism, Criminal Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MindfulnessBehavioural
Mindfulness-based Relapse Prevention. Guided meditation/discussion (Group sessions).
Relapse PreventionBehavioural
Relapse Prevention. Cognitive behavioral principles/strategies (Group sessions).
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness | Experimental | Mindfulness Receives: Behavioral: Mindfulness |
| Relapse Prevention | Experimental | Not described Receives: Behavioral: Relapse Prevention |
| Waitlist Control | No intervention | Not described |
| Treatment as Usual | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline alcohol craving
Penn Alcohol Craving Scale. 5-item, self-report measure assessing frequency, intensity, and duration of craving, and overall rating of craving for the previous week. Total score range 0-30. Higher scores indicate higher craving.
Measured: 4 weeks, 8 weeks, and after release from incarceration (every 3 months)
Change from baseline daily alcohol consumption
Timeline Follow Back
Measured: Every 3 months after release from incarceration
Change from baseline temptation to drink alcohol
Abstinence Self-Efficacy Scale. 40-item, self-report measure assessing how tempted the participant found themselves to drink under various circumstances. Total score range 0-160. Higher scores indicate higher temptation to drink.
Measured: 4 weeks, 8 weeks, and after release from incarceration (every 3 months)
Criminal Behavior
Crime Inventory
Measured: An average of six months after release from incarceration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2019
- Study start1 Jul 2018
- Primary completion30 Apr 2025
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol AbuseStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 392 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Mind Research Network
- Sponsor type
- University, hospital or other
- Collaborators
- University of Wisconsin, Madison
- Responsible party
- Principal investigator, Kent Kiehl, The Mind Research Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03883646
- Sponsor's protocol ID
- 18114
- Acronym
- MIT
- Status last verified
- Sep 2025
- First submitted
- 18 Mar 2019
- Last updated
- 26 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness for Alcohol Abusing Offenders
- ClinicalTrials.gov ID
- NCT03883646
- Acronym / sponsor ID
- MIT / 18114
- Conditions
- Alcohol Abuse, Criminal Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 392 participants (actual)
- Lead sponsor
- The Mind Research NetworkUniversity, hospital or other
- Collaborators
- University of Wisconsin, Madison
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 21 Mar 2019 (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.
Over half of state and federal prisoners meet clinical criteria for alcohol abuse or dependence, and after release from prison, over three-quarters of offenders are re-arrested within five years. Thus, there is a critical need for more effective interventions that could help disrupt this insidious cycle of alcohol abuse, criminal behavior, and incarceration. This project will support the development and evaluation of a mindfulness intervention for female prison inmates that will target key neuropsychological vulnerabilities that are associated with relapse and recidivism.
Detailed description
The pernicious link between substance abuse and criminal behavior imposes major costs to society, totaling billions of dollars in the U.S. annually. There is a critical need for more effective interventions to counteract the high rates of relapse and recidivism in alcohol and substance abusing criminal offenders. Periods of offender incarceration provide a unique opportunity to develop and deploy such interventions. Progress in intervention development could be achieved by targeting specific cognitive and affective vulnerabilities that are common among substance abusing criminal offenders. Preliminary studies suggest that meditative or mindfulness interventions may confer significant psychological and behavioral benefits to inmates. However, the mechanisms and extent of intervention efficacy are unclear, as these previous studies have been beset by a number of methodological limitations. Moreover, to date no study has examined the neurobiological mechanisms that relate to treatment success in this population. NIAAA has recently made a program call to address these issues (PA-15-299). Here we answer this program call and propose to undertake a rigorous and comprehensive longitudinal study of mindfulness treatment of alcohol and substance use disorders among female inmates. This project will randomly assign over 400 female inmates to a mindfulness or relapse prevention training course, and both will be compared against a no treatment control. The mindfulness intervention will be tailored to address two key neuropsychological deficits in alcohol abusing criminal offenders: impulsivity and craving. We will test hypotheses about the neural changes over time with treatment to elucidate mechanisms of change. We will obtain estimates of "real-world" efficacy of the intervention by collecting outcome measures in prison (conduct reports) and following release (alcohol use relapse and antisocial behavior). This project takes advantage of a unique, longstanding partnership between the research team and the states of New Mexico and Wisconsin Correction Departments that allows collection of comprehensive assessment data from inmates during incarceration, including brain imaging data with a mobile MRI scanner, as well as access to post-release outcomes and relapse data. Completion of these aims is a critical step for implementing and evaluating a promising mindfulness intervention for this high-risk population. The proposed research will also begin to elucidate the psychological and neurobiological mechanisms of the treatment. These results will thus significantly advance a program of research seeking to translate the growing knowledge of neuropsychological deficits into more targeted and effective treatments for alcohol and substance abuse problems in criminal offenders.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Mindfulness | Experimental | Behavioral: MindfulnessMindfulness |
| Relapse Prevention | Experimental | Behavioral: Relapse Prevention |
| Waitlist Control | No intervention | – |
| Treatment as Usual | No intervention | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18-65 years of age
- Alcohol Use Disorder
- Female (biological sex at birth)
- Time to release from incarceration > 3 months
- 5th grade or higher reading level
Key exclusion criteria (6 listed)
- Uncorrectable auditory or visual deficits
- Intelligence Quotient score below 70
- History of dementia or other cognitive disability
- Current psychotic disorder (chronic schizophrenia or schizoaffective disorder and/or active psychotic symptoms)
- Major medical illness or Central Nervous System disease
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 |
|---|---|---|
| MindfulnessMindfulness-based Relapse Prevention. Guided meditation/discussion (Group sessions). | Behavioural | Mindfulness |
| Relapse PreventionRelapse Prevention. Cognitive behavioral principles/strategies (Group sessions). | Behavioural | Relapse Prevention |
Primary outcome
Change from baseline alcohol craving
Time frame: 4 weeks, 8 weeks, and after release from incarceration (every 3 months)
Penn Alcohol Craving Scale. 5-item, self-report measure assessing frequency, intensity, and duration of craving, and overall rating of craving for the previous week. Total score range 0-30. Higher scores indicate higher craving.
Change from baseline daily alcohol consumption
Time frame: Every 3 months after release from incarceration
Timeline Follow Back
Change from baseline temptation to drink alcohol
Time frame: 4 weeks, 8 weeks, and after release from incarceration (every 3 months)
Abstinence Self-Efficacy Scale. 40-item, self-report measure assessing how tempted the participant found themselves to drink under various circumstances. Total score range 0-160. Higher scores indicate higher temptation to drink.
Criminal Behavior
Time frame: An average of six months after release from incarceration
Crime Inventory
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 26 Sep 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Relapse Prevention in people with Alcohol Abuse and Criminal Behavior, run by The Mind Research Network 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 6 inclusion and 6 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 26 Sep 2025. 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 from baseline alcohol craving (time frame: 4 weeks, 8 weeks, and after release from incarceration (every 3 months)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Sep 2025.