Alcohol UseWAVENCT06982443
Wellness, Alcohol, Vitals, and Emotions
A study testing Mindfulness based relapse prevention in people with Alcohol Use, run by University of New Mexico at 1 site in United States.
Trial summary
The goal of this clinical trial is to examine the effects of mindfulness based relapse prevention on self-regulation overtime and drinking in daily life through the use of wearable heart rate sensors during mindfulness groups and answering assessment questions 3 times per day during the course of treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol Use
- What is being tested?
- Mindfulness based relapse prevention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2025to 1 Sep 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- 18 years of age or older
- Meet criteria for a moderate to severe alcohol use disorder within the previous 3-months.
- Able to attend group meetings at the time listed on the recruitment materials.
- Willing to wear a sensor for the 8-week intervention period and return the sensor after the immediate follow-up.
- Have a phone/tablet/computer with internet access.
- Be able to comprehend and consent to study requirements in English.
- Have access to a valid U.S. mailing address for receiving the HRV sensors and reside in the United States.
Who cannot join
- Current symptoms of psychosis or mania.
- Have a substance use disorder requiring a higher level of care than outpatient treatment (e.g., severe alcohol use disorder requiring inpatient detoxification).
- Have a history of pulmonary or cardiovascular disease that interferes with sensor data collection and HRV metrics (i.e., ectopic beats, arrythmia, congenital heart disease).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of New Mexico
Albuquerque, New Mexico, 87131
Matison W McCool, PhD, 505-228-0142, mwmccool@unm.edu
About this study
Official title: Mindfulness-Based Relapse Prevention and Psychophysiological Self-Regulation
The goal of this clinical trial is to examine the effects of mindfulness based relapse prevention on self-regulation overtime and drinking in daily life through the use of wearable heart rate sensors during mindfulness groups and answering assessment questions 3 times per day during the course of treatment. The main questions that it aims to answer are:
- What changes in self-regulation as measured through heart rate variability are observed during a mindfulness intervention and how do those self-regulatory changes affect drinking after treatment?
- How do changes in heart rate variability affect drinking, craving, and negative affectivity in daily life?
Read more
Participants will:
- Answer questions related to their mood and drinking behaviors.
- Wear their sensors during an 8-week treatment period with 1 group per week.
- Answer questions 3 times a day during the treatment period. 4.) Return their sensors via a pre-stamped package and answer questions about their mood and drinking behaviors 3- and 6-months after the mindfulness groups end.
Read the detailed description
This study will assess the changes in self-regulation as measured through heart rate variability (HRV), that occur during the course of an 8-week mindfulness-based relapse prevention (MBRP) treatment. The investigators will use a single-group design to test the effects of MBRP on resting, reactivity, and recovery HRV. Additionally, the study will test whether changes in HRV that occur week over week during treatment can affect drinking behaviors in daily life. Individuals (n=120) who meet criteria for moderate to severe alcohol use disorder will be mailed small HRV sensors to be worn before, during, and after each MBRP group. Participants will answer questions about their functioning, alcohol use, addiction cycle domains, and mood at baseline, and at follow-up months 3 and 6.
MBRP groups will be delivered at the same time each week for 8 consecutive weeks, known as the treatment period. During the treatment period, participants will self-attach their sensors before each MBRP group, watch a brief presentation to collect resting HRV, complete their group, and watch a brief presentation after each group. During the treatment period, participants will also answer questions about their drinking, functioning, and mood 3 times a day.
- Conditions
- Alcohol Use
- Being tested
- Mindfulness based relapse prevention
- Keywords
- alcohol, mindfulness, harm reduction
- Medical subject headings
- Alcohol Drinking, Harm Reduction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness based relapse preventionBehavioural
Also called MBRP
Mindfulness-based relapse prevention (MBRP) is a group-based treatment to provide individuals with skills intended to foster increased awareness of triggers, destructive habitual patterns, and "automatic" reactions to triggering experiences. Mindfulness practices in MBRP are designed to help individuals pause, observe present experience, and bring awareness to the range of choices available in every moment. Through MBRP individuals learn to respond in ways that serve them, rather than react in ways that are detrimental to their health and happiness.
| Study group | Role | What they receive |
|---|---|---|
| MBRP | Experimental | Not described Receives: Behavioral: Mindfulness based relapse prevention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recovery from AUD
Recovery is a binary (yes/no) outcome defined by achieving all three of the following: (1) Remission from Diagnostic and Statistical Manual, 5th edition alcohol use disorder (AUD) based on an 11-item AUD symptom checklist (endorsing 0 or 1 item is AUD remission); (2) Cessation of heavy drinking (defined as not engaging in heavy drinking with heavy drinking defined as 4 or more drinks per occasion for females, and 5 or more drinks per occasion for males, measured by the Timeline Follow-Back); and (3) Improvements in functioning and well-being as measured by higher score on the PROMIS PROPr measure. Recovery is achieved if remission, cessation of heavy drinking, and improvements in functioning and well-being are achieved. These assessments will be delivered at Baseline, 3-month, and 6-month follow-ups.
Measured: Change from baseline to 6-month follow-up
Psychophysiological self-regulation
Psychophysiological self-regulation will be measured through three heart rate variability (HRV) domains: HRV at rest (higher RMSSD/HF-HRV indicate higher self-regulation), reactivity HRV (no change, or increases in HRV indicate less reactivity), and recovery HRV (quicker return to resting HRV indicates greater recovery from stress). The three HRV domains will be assessed at baseline, mid-treatment, and immediately following treatment. Tonic HRV is assessed each week before and after the mindfulness group.
Measured: Change from baseline to immediate follow-up
Addiction Cycle Domains in Daily Life
The negative emotionality domain of the addiction cycle is characterized by temptation to drink in situations when the person is experiencing negative emotions. The Negative Emotionality Scale consists of 2 items scored on a scale from 1=not at all tempted to 5=extremely tempted to drink when experiencing negative emotions. The incentive salience domain of the addiction cycle is characterized by temptation to drink in situations when the person is experiencing rewarding or social pressure to drink. The Incentive Salience Scale consists of 2 items scored on a scale from 1=not at all tempted to 5=extremely tempted to drink when experiencing rewarding, craving, or social situations. The executive function domain of the addiction cycle is characterized by loss of control over drinking. The Executive Scale consists 2 items scored on a scale from 1=indicating more control over drinking to 5=indicating loss. These ecological momentary assessment adapted scales will be delivered 3x per day.
Measured: Measured 3x daily
Secondary outcomes (5)
PROMIS Alcohol Negative Consequences
The Patient-Reported Outcomes Measurement Information System (PROMIS®) includes 7 items scored from never=1 to almost always=5 that assess negative consequences from alcohol use (e.g., I used poor judgment when I drank). The PROMIS Negative Alcohol Consequences measure will be administered once at baseline, and at follow-up months 3 and 6. Higher scores indicate more negative consequences.
Measured: Change between baseline and 6-month follow-up
Penn Alcohol Craving Scale
Five item measure of overall craving for alcohol. Responses range from 0 to 6 where 0 represents the absence of the specific craving symptom in the item, and 6 represents the maximum intensity or frequency of the craving symptom in the item. The Penn Alcohol Craving Scale will be administered once at baseline, and at follow-up months 3 and 6. Higher scores on the Penn Alcohol Craving Scale reflect more severe alcohol craving.
An adapted version of the craving scale will be used 3x daily to assess momentary craving
Measured: Change from baseline to 6-month follow-up/ 3x daily
Reduction in percent heavy drinking days
Percent heavy drinking days will be calculated using the Timeline Follow-Back calendar method of assessing standard alcohol drinks consumed each day over the past 90 days. This measure will be used to identify the total number of occasions of daily heavy drinking (defined as 4 or more drinks for females and 5 or more drinks for males), and the percent heavy drinking days will be calculated as the number of heavy drinking days in the past 90 days divided by the total number of days in that time period (typically 90 days, unless some days are missing). The Timeline Follow-Back Calendar will be administered once at baseline, and at follow-up months 3 and 6. Higher percent heavy drinking days indicate more heavy drinking occasions in a 90-day period.
Measured: Change from baseline to 6-month follow-up
Reduction in drinks per drinking day
Drinks per drinking day will be calculated using the Timeline Follow-Back calendar method of assessing standard alcohol drinks consumed each day over the past 90 days. This measure will be used to identify the total number of drinks consumed on each drinking day, and the number of drinks per drinking drinking days will be calculated as the total number of drinks consumed in the past 90 days divided by the total number of days in that time period when drinking occurred (typically 90 days, unless some days are missing). The Timeline Follow-Back Calendar will be administered once at baseline, and at follow-up months 3 and 6. Higher drinks per drinking day indicates greater intensity of drinking in a 90-day period.
Measured: Change from baseline to 6-month follow-up
Daily drinking quantity and frequency
The frequency and quantity of drinking will be assessed 3x daily during the 8-week intervention period. A binary outcome of a drinking episode will be used to assessed drinking frequency each day. Quantities will be assessed by asking how many standard drinks the person had (if they reported drinking between assessment periods).
Measured: 3x daily during 8-week intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2025
- Study start1 Oct 2025
- Primary completion31 Mar 2028 (estimated)
- Study completion1 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol UseStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of New Mexico
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Matison McCool, University of New Mexico
- Investigators
- Matison W McCool, Phd, Principal investigator, Center on Alcohol, Substance use, And Addictions - The University of New Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06982443
- Sponsor's protocol ID
- 2407142185
- Other IDs
- K23AA031729
- Acronym
- WAVE
- Status last verified
- Jul 2026
- First submitted
- 13 May 2025
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The investigators will comply with all NIAAA Data Archives policies established during the project period. This includes compliance with the NIAAA central data platform requirements and timelines developed through the NIAAA Data Share.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness-Based Relapse Prevention and Psychophysiological Self-Regulation
- ClinicalTrials.gov ID
- NCT06982443
- Acronym / sponsor ID
- WAVE / 2407142185
- Conditions
- Alcohol Use
- Keywords
- alcohol, mindfulness, harm reduction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of New MexicoUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 1 Sep 2029 (estimated)
- First posted
- 21 May 2025 (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.
The goal of this clinical trial is to examine the effects of mindfulness based relapse prevention on self-regulation overtime and drinking in daily life through the use of wearable heart rate sensors during mindfulness groups and answering assessment questions 3 times per day during the course of treatment. The main questions that it aims to answer are:
- What changes in self-regulation as measured through heart rate variability are observed during a mindfulness intervention and how do those self-regulatory changes affect drinking after treatment?
- How do changes in heart rate variability affect drinking, craving, and negative affectivity in daily life?
Participants will:
- Answer questions related to their mood and drinking behaviors.
- Wear their sensors during an 8-week treatment period with 1 group per week.
- Answer questions 3 times a day during the treatment period. 4.) Return their sensors via a pre-stamped package and answer questions about their mood and drinking behaviors 3- and 6-months after the mindfulness groups end.
Detailed description
This study will assess the changes in self-regulation as measured through heart rate variability (HRV), that occur during the course of an 8-week mindfulness-based relapse prevention (MBRP) treatment. The investigators will use a single-group design to test the effects of MBRP on resting, reactivity, and recovery HRV. Additionally, the study will test whether changes in HRV that occur week over week during treatment can affect drinking behaviors in daily life. Individuals (n=120) who meet criteria for moderate to severe alcohol use disorder will be mailed small HRV sensors to be worn before, during, and after each MBRP group. Participants will answer questions about their functioning, alcohol use, addiction cycle domains, and mood at baseline, and at follow-up months 3 and 6.
MBRP groups will be delivered at the same time each week for 8 consecutive weeks, known as the treatment period. During the treatment period, participants will self-attach their sensors before each MBRP group, watch a brief presentation to collect resting HRV, complete their group, and watch a brief presentation after each group. During the treatment period, participants will also answer questions about their drinking, functioning, and mood 3 times a day.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MBRP | Experimental | Behavioral: Mindfulness based relapse prevention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18 years of age or older
- Meet criteria for a moderate to severe alcohol use disorder within the previous 3-months.
- Able to attend group meetings at the time listed on the recruitment materials.
- Willing to wear a sensor for the 8-week intervention period and return the sensor after the immediate follow-up.
- Have a phone/tablet/computer with internet access.
Key exclusion criteria (3 listed)
- Current symptoms of psychosis or mania.
- Have a substance use disorder requiring a higher level of care than outpatient treatment (e.g., severe alcohol use disorder requiring inpatient detoxification).
- Have a history of pulmonary or cardiovascular disease that interferes with sensor data collection and HRV metrics (i.e., ectopic beats, arrythmia, congenital heart 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 |
|---|---|---|
| Mindfulness based relapse preventionAlso: MBRPMindfulness-based relapse prevention (MBRP) is a group-based treatment to provide individuals with skills intended to foster increased awareness of triggers, destructive habitual patterns, and "automatic" reactions to triggering experiences. Mindfulness practices in MBRP are designed to help individuals pause, observe present experience, and bring awareness to the range of choices available in every moment. Through MBRP individuals learn to respond in ways that serve them, rather than react in ways that are detrimental to their health and happiness. | Behavioural | MBRP |
Primary outcome
Recovery from AUD
Time frame: Change from baseline to 6-month follow-up
Recovery is a binary (yes/no) outcome defined by achieving all three of the following: (1) Remission from Diagnostic and Statistical Manual, 5th edition alcohol use disorder (AUD) based on an 11-item AUD symptom checklist (endorsing 0 or 1 item is AUD remission); (2) Cessation of heavy drinking (defined as not engaging in heavy drinking with heavy drinking defined as 4 or more drinks per occasion for females, and 5 or more drinks per occasion for males, measured by the Timeline Follow-Back); and (3) Improvements in functioning and well-being as measured by higher score on the PROMIS PROPr measure. Recovery is achieved if remission, cessation of heavy drinking, and improvements in functioning and well-being are achieved. These assessments will be delivered at Baseline, 3-month, and 6-month follow-ups.
Psychophysiological self-regulation
Time frame: Change from baseline to immediate follow-up
Psychophysiological self-regulation will be measured through three heart rate variability (HRV) domains: HRV at rest (higher RMSSD/HF-HRV indicate higher self-regulation), reactivity HRV (no change, or increases in HRV indicate less reactivity), and recovery HRV (quicker return to resting HRV indicates greater recovery from stress). The three HRV domains will be assessed at baseline, mid-treatment, and immediately following treatment. Tonic HRV is assessed each week before and after the mindfulness group.
Addiction Cycle Domains in Daily Life
Time frame: Measured 3x daily
The negative emotionality domain of the addiction cycle is characterized by temptation to drink in situations when the person is experiencing negative emotions. The Negative Emotionality Scale consists of 2 items scored on a scale from 1=not at all tempted to 5=extremely tempted to drink when experiencing negative emotions. The incentive salience domain of the addiction cycle is characterized by temptation to drink in situations when the person is experiencing rewarding or social pressure to drink. The Incentive Salience Scale consists of 2 items scored on a scale from 1=not at all tempted to 5=extremely tempted to drink when experiencing rewarding, craving, or social situations. The executive function domain of the addiction cycle is characterized by loss of control over drinking. The Executive Scale consists 2 items scored on a scale from 1=indicating more control over drinking to 5=indicating loss. These ecological momentary assessment adapted scales will be delivered 3x per day.
5 secondary outcomes
PROMIS Alcohol Negative Consequences
Time frame: Change between baseline and 6-month follow-up
Penn Alcohol Craving Scale
Time frame: Change from baseline to 6-month follow-up/ 3x daily
Reduction in percent heavy drinking days
Time frame: Change from baseline to 6-month follow-up
Reduction in drinks per drinking day
Time frame: Change from baseline to 6-month follow-up
Daily drinking quantity and frequency
Time frame: 3x daily during 8-week intervention period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
- Individual participant dataSharing planned: Yes. The investigators will comply with all NIAAA Data Archives policies established during the project period. This includes compliance with the NIAAA central data platform requirements and timelines developed through the NIAAA Data Share.
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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.
Matison W McCool, Phd principal investigator
Center on Alcohol, Substance use, And Addictions - The University of New Mexico
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 based relapse prevention in people with Alcohol Use, run by University of New Mexico 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 7 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 15 Jul 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recovery from AUD (time frame: Change from baseline to 6-month follow-up). The study lists 3 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 15 Jul 2026.