Heavy DrinkingNCT07516873
Exploring the Effects of Brief Mindfulness Training With Vagal Nerve Stimulation on Alcohol Cue Reactivity Among Young Adult Heavy Drinkers
A study testing Active RAVANS and Brief Mindfulness-Based Intervention in people with Heavy Drinking, run by Cambridge Health Alliance at 1 site in United States.
Trial summary
The present study will assess the acceptability and feasibility of a brief intervention designed to help young heavy drinkers reduce their alcohol consumption. All participants will complete a brief (1-week) mindfulness intervention, and participants will be randomized to receive either active or inactive… Read more about this study
- Who is it for?
- Ages 21 to 29 years
- Conditions the study is for
- Heavy Drinking
- What is being tested?
- Active RAVANS and Brief Mindfulness-Based Intervention
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Mar 2026to Aug 2026
- 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 21 to 29 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Currently living in Massachusetts.
- Aged 21-29 years old.
- Consume either more than 14 standard drinks of alcohol per week OR at least 5 standard drinks in one day per week (in past 30 days).
- Have sufficient English fluency to understand procedures and questionnaires.
- Have the capacity and ability to provide informed consent.
- Scores at least 15 points on the PACS at screening. Participants who score between 10 and 14 pts will undergo additional doctoral-level review to assess eligibility.
Who cannot join
- Current or past diagnosis of a substance use disorder based on the Quick Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) Module C (Substance Use Disorders).
- Active prescription for sedative/hypnotics, opioids, or anesthetic medications.
- Active prescription for medications used to treat alcohol use disorder (AUD), e.g., naltrexone, disulfiram, acamprosate, etc.
- Active psychosis or schizophrenia-spectrum disorder diagnosis.
- Bipolar I disorder history or severe level of mania.
- Severe symptoms of PTSD.
Show all 18Show fewer
- Acute suicidality or self-injurious behavior.
- Cognitive inability as demonstrated by the inability to complete an informed consent assessment with >90% accuracy after 2 attempts.
- Current participation in another experimental intervention research study.
- Current daily mindfulness practice >10 minutes per day.
- Participation in an 8-week intensive Mindfulness-Based Intervention or residential meditation retreat in past 3 years.
- Expected medical hospitalization in the next 2 months; or are currently pregnant.
- Expected incarceration in the next 2 months.
- Presence of electronic implants, such as heart pacemakers, defibrillators, or pumps.
- Presence of a cardiac rhythm disorder.
- History of seizures.
- Presence of skin disorders or malignant diseases in the area in or around the left ear.
- Lack of alcohol craving as assessed by the PACS during screening (score of < 10 points).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Michael Datko, PhD contact
United States1 site, 1 recruiting
- Recruiting
Center for Mindfulness and Compassion
Malden, Massachusetts, 02148
About this study
Official title: Exploring the Feasibility and Acceptability of Brief Mindfulness Training With Vagal Nerve Stimulation for Reducing Alcohol Consumption Among Young Adults
The present study will assess the acceptability and feasibility of a brief intervention designed to help young heavy drinkers reduce their alcohol consumption. All participants will complete a brief (1-week) mindfulness intervention, and participants will be randomized to receive either active or inactive Respiratory-gated Auricular Vagal Afferent Nerve Stimulation (RAVANS) during two in-person laboratory visits. Heart rate variability data and self-report survey data will be collected to assess the impact of the intervention on autonomic regulation, alcohol consumption, and additional clinical measures.
Read the detailed description
After consenting to participate in the study, participants will complete a baseline survey battery online via REDCap while with the Research Coordinator/Research Assistant (RC/RA) in the consent/screening call. During this call, the RC/RA will also schedule the participant's two in-person lab visits. The first lab visit will be scheduled for approximately one week from the consent call, but no more than two weeks from the consent call and baseline survey battery. The second lab visit will take place 1 week after the first lab visit +/- 3 business days if the participant or study team need to reschedule for any reason. Participants will attend a final virtual visit on Zoom or Google Meets 1 week (+/- 3 business days) after the second lab visit to complete follow-up surveys via REDCap.
A trained RC/RA will run participants through lab visits 1 and 2, and at least one senior study team member will be present in the Center for Mindfunless and Compassion (CMC) office space during the visit so that they are available to help troubleshoot if issues arise with the RAVANS stimulation set-up.
During lab visit 1, participants will: complete a 30-minute survey battery via REDCap on a study computer, engage in four 5-minute resting periods for heart rate variability measurements spaced throughout the session, complete a fit test to set up the RAVANS device and ear electrode, and engage in a drinking-related stimuli exposure task including visual cues. After visual cues participants will have initial 10 minute exposure to either active or inactive RAVANS stimulation based on randomization. Additionally, participants will complete a short set of surveys at the end of the visit.
During lab visit 2, participants will: complete a 30-minute survey battery via REDCap on a study computer, engage in four 5-minute resting periods for heart rate variability measurements spaced throughout the session, complete a 30-minute session with active or inactive RAVANS while listening to a mindful breathing audio recording. Participants will be exposed to visual drinking related cues twice: once without the RAVANS device and once with the RAVANS device (active or inactive depending on randomization status). Additionally, participants will complete a short set of surveys at the end of the visit.
Survey Battery:
Participants will fill out a series of self-report assessments in REDCap (see Data/Specimen Collection Procedures for list of assessments). They will complete these assessments at each lab visit and during a follow-up virtual visit approximately 1-week after lab visit 2.
HRV Set-Up and 5-minute Rest Periods:
After completing the questionnaires, each participant will be guided through putting on a Movesense MD device. This device is a wearable ECG sensor that is worn over the heart area using one of three chest straps (small, medium, or large) designed for use with the device. The Movesense MD will use a Bluetooth transmitter to deliver heart rate data to a device with Kubios Heart Rate Variability (HRV) Scientific software installed for data handling. Once a participant has put on the Movesense MD device and a member of the research team has confirmed that the device is functioning properly, the participant will be asked to find a comfortable position in their seat and try to sit still without thinking about anything in particular while their resting heart rate variability is measured for 5 minutes. Participants will complete similar 5-minute rest period throughout the lab visit protocol.
Drinking-Related Stimuli Exposure:
Participants will complete an alcohol-related cue reactivity task designed to assess the effects of alcohol-related visual stimuli on autonomic nervous system function, as measured by heart rate variability (HRV). The task will be administered on a study computer using the PsychoPy stimulus presentation toolbox for the Python programming language. The task includes both still images and video clips, some depicting alcohol-related content (e.g., alcoholic beverages, people drinking, alcohol branding), and others depicting neutral content unrelated to alcohol. Visual stimuli are categorized into four types:
Alcohol-related still images Neutral still images Alcohol-related video clips (e.g., alcohol commercials) Neutral video clips (e.g., product commercials unrelated to alcohol) Stimuli will be presented in blocks. Each block of still images will include four images of the same category (alcohol or neutral), each displayed for 5 seconds, for a total of 20 seconds per image block. Video blocks will consist of a single 20-second clip. Blocks will be pseudorandomized to avoid sequential repetition of the same stimulus type and to ensure balanced exposure across conditions. Between blocks, a fixation cross will be presented for a variable inter-block interval (e.g., 10-20 seconds) to allow HRV to return toward baseline.
Electrocardiogram (ECG) data will be recorded continuously throughout the task to assess HRV responses to alcohol versus neutral cues. No alcohol will be physically present during the study session.
RAVANS and Mindful Breathing:
RAVANS transcutaneous vagal nerve stimulation (tVNS) will be performed with a reusable electrode attached to the surface of the cymba and cavum concha of the auricle. A fit test will be conducted to ensure that the participant is using the proper electrode for their ear shape and size. A small current will be delivered with a constant current stimulator. For active tVNS, current amplitude will be set between the sensitivity threshold and the pain threshold for each subject. The output current will be increased gradually to a maximum of 5 milliamperes (mA) in 0.25-mA increments to allow accommodation to the stimulation until a comfortable tolerance level is reached. For inactive stimulation, electrodes will be placed in the same location of active tVNS but no electrical pulses will be administered. Both the active and inactive RAVANS tVNS groups will be told that they may or may not be able to feel the stimulation that the device is delivering. Respiratory gating for stimulation will require real-time evaluation of the respiratory cycle. A pneumatic belt will be placed around the subject's lower thorax. Low-compliance tubing will connect this belt to a pressure transducer (Omegadyne, Inc., Sunbury, Ohio), thereby producing voltage data that corresponds to changes in respiratory volume. The voltage signal from the transducer will be acquired by a laptop-controlled device. An adaptive threshold detection method will be employed to detect end-inspiration and end-expiration in real-time and send a Transistor-Transistor Logic (TTL) signal to a miniature high-frequency relay (Omron Electronics Components, Shaumburg, IL), controlling the timing of the stimulation. Correct respiratory-gated stimulation will be confirmed by the experimenter via running chart of the respiration signal and stimulus pulse. After the RAVANS device has been set up and calibrated, the participant will be guided through using the device during a mindful breathing practice for 30 minutes.
Intervention Week:
Participants will be provided a 10-minute audio meditation. They will be encouraged to listen to it daily during 6 out of the 7 days between lab visit one and lab visit two.
1-Week Follow-Up procedures: The study team will schedule a virtual visit with participants for 1-week after their 2nd lab visit. This visit will take place via Zoom or Google Meets. Participants will complete the final survey battery via REDCap on the call with a study team member to ensure robust data collection for this final timepoint. This visit will take 30-45 minutes. At the end of this visit, participants will be informed that study activities are complete and that their participation in the study has ended.
- Conditions
- Heavy Drinking
- Being tested
- Active RAVANS, Brief Mindfulness-Based Intervention
- Keywords
- Heavy Drinking, Mindfulness, Vagus Nerve Stimulation, Alcohol Cue Reactivity, Heart Rate Variability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active RAVANSDevice
RAVANS employs non-invasive, transcutaneous auricular vagal nerve stimulation (taVNS) to stimulate vagal afferent nerve fibers exclusively during exhalation. Linking stimulation to exhalation creates a synergistic effect that appears to increase parasympathetic tone and impacts key brain areas implicated in problematic drinking, including the anterior cingulate cortex and prefrontal cortex. Because mindfulness training appears to impact complimentary neural mechanisms, applying stimulation during the outbreath of mindfulness practice may potentiate its effects, accelerate training, and improve capacity for attention and emotion regulation.
Brief Mindfulness-Based InterventionBehavioural
Mindfulness-based interventions may improve interoceptive awareness and heart rate variability outcomes. Participants will be asked to practice 10 minutes of mindfulness meditation daily for 6 out of 7 days during the intervention week. They will also listen to a 30-minute mindfulness of breathing audio recording during Laboratory Visit 2.
| Study group | Role | What they receive |
|---|---|---|
| Active RAVANS | Experimental | These participants will use a RAVANS device set to deliver non-invasive, transcutaneous auricular vagal nerve stimulation (taVNS) to stimulate vagal afferent nerve fibers exclusively during exhalation. Participants will be asked to use this device during two lab visits one week apart:
Visit 1: Participants will be fitted with the device for 20-minutes followed by a 10-minute device session.
Visit 2: Participants will have one 30-minute device session with concurrent mindful breathing followed by a 5-minute session with the device while viewing alcohol-related visual cues. Receives: Device: Active RAVANS; Behavioral: Brief Mindfulness-Based Intervention |
| Inactive RAVANS | Sham comparator | These participants will employ a RAVANS device in sham mode, in which the device will not deliver electrical stimulation. Participants will be asked to use this device during two lab visits one week apart:
Visit 1: Participants will be fitted with the device for 20-minutes followed by a 10-minute inactive device session.
Visit 2: Participants will have one sham 30-minute device session with concurrent mindful breathing followed by a sham 5-minute session with the device while viewing alcohol-related visual cues. Receives: Behavioral: Brief Mindfulness-Based Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
RAVANS Effect on HRV Recovery
The primary outcome measure will be the mean normalized high-frequency heart rate variability (HF-HRV) power collected from the MoveSense device. This data will be collected continuously throughout Lab Visit 1 and Lab Visit 2. Outcome 1A will be the RAVANS effect on HRV recovery after craving cues, comparing across arms.
Measured: 2 weeks (Timepoints: During Lab Visit 1 and Lab Visit 2)
Mindfulness Effect on HRV Recovery
The primary outcome measure will be the mean normalized high-frequency heart rate variability (HF-HRV) power collected from the MoveSense device. This data will be collected continuously throughout Lab Visit 1 and Lab Visit 2. Outcome 1B will be Mindfulness intervention related Change in HRV recovery after craving cues, comparing Lab Visit 1 (no mindfulness training) to Lab Visit 1 (1-week of mindfulness training).
Measured: 2 weeks (Timepoints: During Lab Visit 1 and Lab Visit 2)
RAVANS Effect on HRV Response to Cues
The primary outcome measure will be the mean normalized high-frequency heart rate variability (HF-HRV) power collected from the MoveSense device. This data will be collected continuously throughout Lab Visit 1 and Lab Visit 2. Outcome 1C will be the RAVANS effect on HRV response during craving cues, comparing across arms.
Measured: 2 weeks (Timepoints: During Lab Visit 1 and Lab Visit 2)
Secondary outcomes (3)
Acceptability Measure
This outcome will assess the acceptability of mindfulness combined with Active RAVANS versus mindfulness combined with Inactive RAVANS among heavy alcohol drinkers. Participants in both study arms will rate the likelihood of recommending the intervention to family or friends interested in reducing their drinking, using a 7-point Likert scale (1 = "would definitely not recommend" to 7 = "would definitely recommend"). This is a 1 item measure and acceptability will be defined as a post-intervention mean rating greater than 4. Range of total score for this scale is 1-7 and higher scores indicate more acceptability.
Measured: 3 weeks (Timepoint: 1-week follow-up)
The International Positive and Negative Affect Schedule Short Form (I-PANAS-SF)
This outcome will assess whether the combination of mindfulness practice and Active RAVANS is associated with changes in affective state. Affect will be measured using the International Positive and Negative Affect Schedule Short Form (I-PANAS-SF). The primary metric will be the ratio of mean positive affect ratings to mean negative affect ratings (M_positive / M_negative). This ratio obtained at the end of Lab Visit 2 (mindfulness session) will be compared to the ratio obtained at the end of Lab Visit 1 (control session) between the Active RAVANS and Inactive RAVANS arms. This 10-item self-report measure consisting of two 5-item subscales (Positive Affect and Negative Affect), each scored from 10 to 50, with higher scores on each subscale indicating greater levels of that affect.
Measured: 3 weeks (Timepoints: pre/post Lab Visit 1, pre/post Lab Visit 2, 1 week follow-up)
7-day and 14-day Timeline Follow Back
This outcome will assess changes in alcohol consumption following mindfulness combined with Active RAVANS compared to mindfulness combined with Inactive RAVANS. Alcohol use will be measured using the TimeLine Follow-Back (TLFB) method, a standardized clinical and research assessment tool developed by Linda Sobell (Nova Southeastern University, 1996). The TLFB provides quantitative estimates of alcohol use over a specified recall period. Alcohol consumption reported after Lab Visit 2 will be compared between the Active RAVANS and Inactive RAVANS arms. This measure yields continuous outcomes such as total drinks, drinks per drinking day, percent drinking days, and percent heavy drinking days, with lower values indicating less alcohol use. There is no minimum or maximum on reported consumption.
Measured: 3 weeks (Timepoints: Screening, Lab Visit 1, Lab Visit 2, 1 week follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2026
- Study start6 Mar 2026
- Primary completionAug 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heavy DrinkingStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a 2-arm design to allow the investigators to evaluate the feasibility and acceptability of both the treatment and control arms of a future fully-powered randomized controlled trial (RCT) evaluating the effects of the intervention.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cambridge Health Alliance
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zev Schuman-Olivier, MD, Principal investigator, Cambridge Health Alliance
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07516873
- Sponsor's protocol ID
- CHA-IRB-24-25-409
- Status last verified
- May 2026
- First submitted
- 1 Apr 2026
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is currently no plan to make individual participant data available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Feasibility and Acceptability of Brief Mindfulness Training With Vagal Nerve Stimulation for Reducing Alcohol Consumption Among Young Adults
- ClinicalTrials.gov ID
- NCT07516873
- Acronym / sponsor ID
- CHA-IRB-24-25-409
- Conditions
- Heavy Drinking
- Keywords
- Heavy Drinking, Mindfulness, Vagus Nerve Stimulation, Alcohol Cue Reactivity, Heart Rate Variability
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cambridge Health AllianceUniversity, hospital or other
- Study start
- 6 Mar 2026 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 8 Apr 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.
The present study will assess the acceptability and feasibility of a brief intervention designed to help young heavy drinkers reduce their alcohol consumption. All participants will complete a brief (1-week) mindfulness intervention, and participants will be randomized to receive either active or inactive Respiratory-gated Auricular Vagal Afferent Nerve Stimulation (RAVANS) during two in-person laboratory visits. Heart rate variability data and self-report survey data will be collected to assess the impact of the intervention on autonomic regulation, alcohol consumption, and additional clinical measures.
Detailed description
After consenting to participate in the study, participants will complete a baseline survey battery online via REDCap while with the Research Coordinator/Research Assistant (RC/RA) in the consent/screening call. During this call, the RC/RA will also schedule the participant's two in-person lab visits. The first lab visit will be scheduled for approximately one week from the consent call, but no more than two weeks from the consent call and baseline survey battery. The second lab visit will take place 1 week after the first lab visit +/- 3 business days if the participant or study team need to reschedule for any reason. Participants will attend a final virtual visit on Zoom or Google Meets 1 week (+/- 3 business days) after the second lab visit to complete follow-up surveys via REDCap.
A trained RC/RA will run participants through lab visits 1 and 2, and at least one senior study team member will be present in the Center for Mindfunless and Compassion (CMC) office space during the visit so that they are available to help troubleshoot if issues arise with the RAVANS stimulation set-up.
During lab visit 1, participants will: complete a 30-minute survey battery via REDCap on a study computer, engage in four 5-minute resting periods for heart rate variability measurements spaced throughout the session, complete a fit test to set up the RAVANS device and ear electrode, and engage in a drinking-related stimuli exposure task including visual cues. After visual cues participants will have initial 10 minute exposure to either active or inactive RAVANS stimulation based on randomization. Additionally, participants will complete a short set of surveys at the end of the visit.
During lab visit 2, participants will: complete a 30-minute survey battery via REDCap on a study computer, engage in four 5-minute resting periods for heart rate variability measurements spaced throughout the session, complete a 30-minute session with active or inactive RAVANS while listening to a mindful breathing audio recording. Participants will be exposed to visual drinking related cues twice: once without the RAVANS device and once with the RAVANS device (active or inactive depending on randomization status). Additionally, participants will complete a short set of surveys at the end of the visit.
Survey Battery:
Participants will fill out a series of self-report assessments in REDCap (see Data/Specimen Collection Procedures for list of assessments). They will complete these assessments at each lab visit and during a follow-up virtual visit approximately 1-week after lab visit 2.
HRV Set-Up and 5-minute Rest Periods:
After completing the questionnaires, each participant will be guided through putting on a Movesense MD device. This device is a wearable ECG sensor that is worn over the heart area using one of three chest straps (small, medium, or large) designed for use with the device. The Movesense MD will use a Bluetooth transmitter to deliver heart rate data to a device with Kubios Heart Rate Variability (HRV) Scientific software installed for data handling. Once a participant has put on the Movesense MD device and a member of the research team has confirmed that the device is functioning properly, the participant will be asked to find a comfortable position in their seat and try to sit still without thinking about anything in particular while their resting heart rate variability is measured for 5 minutes. Participants will complete similar 5-minute rest period throughout the lab visit protocol.
Drinking-Related Stimuli Exposure:
Participants will complete an alcohol-related cue reactivity task designed to assess the effects of alcohol-related visual stimuli on autonomic nervous system function, as measured by heart rate variability (HRV). The task will be administered on a study computer using the PsychoPy stimulus presentation toolbox for the Python programming language. The task includes both still images and video clips, some depicting alcohol-related content (e.g., alcoholic beverages, people drinking, alcohol branding), and others depicting neutral content unrelated to alcohol. Visual stimuli are categorized into four types:
Alcohol-related still images Neutral still images Alcohol-related video clips (e.g., alcohol commercials) Neutral video clips (e.g., product commercials unrelated to alcohol) Stimuli will be presented in blocks. Each block of still images will include four images of the same category (alcohol or neutral), each displayed for 5 seconds, for a total of 20 seconds per image block. Video blocks will consist of a single 20-second clip. Blocks will be pseudorandomized to avoid sequential repetition of the same stimulus type and to ensure balanced exposure across conditions. Between blocks, a fixation cross will be presented for a variable inter-block interval (e.g., 10-20 seconds) to allow HRV to return toward baseline.
Electrocardiogram (ECG) data will be recorded continuously throughout the task to assess HRV responses to alcohol versus neutral cues. No alcohol will be physically present during the study session.
RAVANS and Mindful Breathing:
RAVANS transcutaneous vagal nerve stimulation (tVNS) will be performed with a reusable electrode attached to the surface of the cymba and cavum concha of the auricle. A fit test will be conducted to ensure that the participant is using the proper electrode for their ear shape and size. A small current will be delivered with a constant current stimulator. For active tVNS, current amplitude will be set between the sensitivity threshold and the pain threshold for each subject. The output current will be increased gradually to a maximum of 5 milliamperes (mA) in 0.25-mA increments to allow accommodation to the stimulation until a comfortable tolerance level is reached. For inactive stimulation, electrodes will be placed in the same location of active tVNS but no electrical pulses will be administered. Both the active and inactive RAVANS tVNS groups will be told that they may or may not be able to feel the stimulation that the device is delivering. Respiratory gating for stimulation will require real-time evaluation of the respiratory cycle. A pneumatic belt will be placed around the subject's lower thorax. Low-compliance tubing will connect this belt to a pressure transducer (Omegadyne, Inc., Sunbury, Ohio), thereby producing voltage data that corresponds to changes in respiratory volume. The voltage signal from the transducer will be acquired by a laptop-controlled device. An adaptive threshold detection method will be employed to detect end-inspiration and end-expiration in real-time and send a Transistor-Transistor Logic (TTL) signal to a miniature high-frequency relay (Omron Electronics Components, Shaumburg, IL), controlling the timing of the stimulation. Correct respiratory-gated stimulation will be confirmed by the experimenter via running chart of the respiration signal and stimulus pulse. After the RAVANS device has been set up and calibrated, the participant will be guided through using the device during a mindful breathing practice for 30 minutes.
Intervention Week:
Participants will be provided a 10-minute audio meditation. They will be encouraged to listen to it daily during 6 out of the 7 days between lab visit one and lab visit two.
1-Week Follow-Up procedures: The study team will schedule a virtual visit with participants for 1-week after their 2nd lab visit. This visit will take place via Zoom or Google Meets. Participants will complete the final survey battery via REDCap on the call with a study team member to ensure robust data collection for this final timepoint. This visit will take 30-45 minutes. At the end of this visit, participants will be informed that study activities are complete and that their participation in the study has ended.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This is a 2-arm design to allow the investigators to evaluate the feasibility and acceptability of both the treatment and control arms of a future fully-powered randomized controlled trial (RCT) evaluating the effects of the intervention.
| Arm | Type | Receives |
|---|---|---|
| Active RAVANS | Experimental | Device: Active RAVANS, Behavioral: Brief Mindfulness-Based InterventionThese participants will use a RAVANS device set to deliver non-invasive, transcutaneous auricular vagal nerve stimulation (taVNS) to stimulate vagal afferent nerve fibers exclusively during exhalation. Participants will be asked to use this device during two lab visits one week apart: Visit 1: Participants will be fitted with the device for 20-minutes followed by a 10-minute device session. Visit 2: Participants will have one 30-minute device session with concurrent mindful breathing followed by a 5-minute session with the device while viewing alcohol-related visual cues. |
| Inactive RAVANS | Sham comparator | Behavioral: Brief Mindfulness-Based InterventionThese participants will employ a RAVANS device in sham mode, in which the device will not deliver electrical stimulation. Participants will be asked to use this device during two lab visits one week apart: Visit 1: Participants will be fitted with the device for 20-minutes followed by a 10-minute inactive device session. Visit 2: Participants will have one sham 30-minute device session with concurrent mindful breathing followed by a sham 5-minute session with the device while viewing alcohol-related visual cues. |
Who may qualify
- Ages
- 21 to 29 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Currently living in Massachusetts.
- Aged 21-29 years old.
- Consume either more than 14 standard drinks of alcohol per week OR at least 5 standard drinks in one day per week (in past 30 days).
- Have sufficient English fluency to understand procedures and questionnaires.
- Have the capacity and ability to provide informed consent.
Key exclusion criteria (18 listed)
- Current or past diagnosis of a substance use disorder based on the Quick Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) Module C (Substance Use Disorders).
- Active prescription for sedative/hypnotics, opioids, or anesthetic medications.
- Active prescription for medications used to treat alcohol use disorder (AUD), e.g., naltrexone, disulfiram, acamprosate, etc.
- Active psychosis or schizophrenia-spectrum disorder diagnosis.
- Bipolar I disorder history or severe level of mania.
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 |
|---|---|---|
| Active RAVANSRAVANS employs non-invasive, transcutaneous auricular vagal nerve stimulation (taVNS) to stimulate vagal afferent nerve fibers exclusively during exhalation. Linking stimulation to exhalation creates a synergistic effect that appears to increase parasympathetic tone and impacts key brain areas implicated in problematic drinking, including the anterior cingulate cortex and prefrontal cortex. Because mindfulness training appears to impact complimentary neural mechanisms, applying stimulation during the outbreath of mindfulness practice may potentiate its effects, accelerate training, and improve capacity for attention and emotion regulation. | Device | Active RAVANS |
| Brief Mindfulness-Based InterventionMindfulness-based interventions may improve interoceptive awareness and heart rate variability outcomes. Participants will be asked to practice 10 minutes of mindfulness meditation daily for 6 out of 7 days during the intervention week. They will also listen to a 30-minute mindfulness of breathing audio recording during Laboratory Visit 2. | Behavioural | Active RAVANS, Inactive RAVANS |
Primary outcome
RAVANS Effect on HRV Recovery
Time frame: 2 weeks (Timepoints: During Lab Visit 1 and Lab Visit 2)
The primary outcome measure will be the mean normalized high-frequency heart rate variability (HF-HRV) power collected from the MoveSense device. This data will be collected continuously throughout Lab Visit 1 and Lab Visit 2. Outcome 1A will be the RAVANS effect on HRV recovery after craving cues, comparing across arms.
Mindfulness Effect on HRV Recovery
Time frame: 2 weeks (Timepoints: During Lab Visit 1 and Lab Visit 2)
The primary outcome measure will be the mean normalized high-frequency heart rate variability (HF-HRV) power collected from the MoveSense device. This data will be collected continuously throughout Lab Visit 1 and Lab Visit 2. Outcome 1B will be Mindfulness intervention related Change in HRV recovery after craving cues, comparing Lab Visit 1 (no mindfulness training) to Lab Visit 1 (1-week of mindfulness training).
RAVANS Effect on HRV Response to Cues
Time frame: 2 weeks (Timepoints: During Lab Visit 1 and Lab Visit 2)
The primary outcome measure will be the mean normalized high-frequency heart rate variability (HF-HRV) power collected from the MoveSense device. This data will be collected continuously throughout Lab Visit 1 and Lab Visit 2. Outcome 1C will be the RAVANS effect on HRV response during craving cues, comparing across arms.
3 secondary outcomes
Acceptability Measure
Time frame: 3 weeks (Timepoint: 1-week follow-up)
The International Positive and Negative Affect Schedule Short Form (I-PANAS-SF)
Time frame: 3 weeks (Timepoints: pre/post Lab Visit 1, pre/post Lab Visit 2, 1 week follow-up)
7-day and 14-day Timeline Follow Back
Time frame: 3 weeks (Timepoints: Screening, Lab Visit 1, Lab Visit 2, 1 week follow-up)
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 12 May 2026.
- Individual participant dataSharing planned: No. There is currently no plan to make individual participant data available to other researchers.
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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.
Michael Datko, PhD contact
Zev Schuman-Olivier, MD principal investigator
Cambridge Health Alliance
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active RAVANS and Brief Mindfulness-Based Intervention in people with Heavy Drinking, run by Cambridge Health Alliance 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 18 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 12 May 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. Some participants in this study may receive a placebo. 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?
Contact Frannie Marin, BS ((617)-643-8770, fmarin@challiance.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
RAVANS Effect on HRV Recovery (time frame: 2 weeks (Timepoints: During Lab Visit 1 and Lab Visit 2)). 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 12 May 2026.