An interventional study of Active RAVANS and Brief Mindfulness-Based Intervention in Heavy Drinking, sponsored by Cambridge Health Alliance. Recruiting at 1 site in United States. Open to participants aged 21 Years to 29 Years. Per ClinicalTrials.gov, last updated 2026-05-12.
Sponsored by Cambridge Health Alliance · Not applicable, Interventional, and Other
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.
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.
Cambridge Health Alliance is the lead sponsor of 52 studies on the registry; 10 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: Active RAVANS · Behavioral: Brief Mindfulness-Based Intervention
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.
Behavioral: Brief Mindfulness-Based Intervention
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.
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.
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.
Time frame: 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).
Time frame: 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.
Time frame: 2 weeks (Timepoints: During Lab Visit 1 and Lab Visit 2)
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.
Time frame: 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.
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
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.
Time frame: 3 weeks (Timepoints: Screening, Lab Visit 1, Lab Visit 2, 1 week follow-up)
Alcohol Urge Questionnaire (AUQ)
The Alcohol Urge Questionnaire (AUQ) consists of eight statements about the respondent's feelings and thoughts about drinking as they are completing the questionnaire (i.e., right now). Drinking refers to various types of alcohol, including beer, wine and liquor. The respondent is asked to respond to each statement about alcohol craving via a 8-item self-report measure of current (state) alcohol craving rated on a 7-point Likert scale ranging from "strongly disagree" to "strongly agree." Total scores range from 8 to 56 and higher scores indicate greater urge to drink.
Time frame: 3 weeks (Timepoints: pre/post Lab Visit 1, pre/post Lab Visit 2, 1 week follow-up)
Multidimensional Assessment of Interoceptive Awareness - Version 2 (MAIA-2)
The Multidimensional Assessment of Interoceptive Awareness (MAIA-2) is a 37-item self-report measure of interoceptive body awareness scored across 8 subscales, with each subscale calculated as the mean of its items and ranging from 0 to 5, where higher scores indicate more interoceptive awareness. The subscales: noticing ("I notice when I am uncomfortable in my body"), not-distracting ("I do not notice (I ignore) physical tension or discomfort until they become more severe"), not-worrying ("I start to worry that something is wrong if I feel any discomfort"), attention regulation ("When I am in conversation with someone, I can pay attention to my posture"), emotional awareness ("I notice that my breathing becomes free and easy when I feel comfortable"), self-regulation ("When I am caught up in thoughts, I can calm my mind by focusing on my body/breathing"), body listening ("I listen to my body to inform me about what to do"), and trusting ("I feel my body is a safe place").
Time frame: 3 weeks (Timepoints: Pre Lab Visit 1, Pre Lab Visit 2, 1 week follow-up)
Five Facet Mindfulness Questionnaire (FFMQ)
The Five Facet Mindfulness Questionnaire (FFMQ) is a 39-item scale that examines five factors that represent aspects of the current empirical conception of mindfulness. These five facets include: "observing, describing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience." An example item is "I pay attention to how my emotions affect my thoughts and behavior." Participants rate their degree of agreement with each of the items on a Likert-type scale ranging from 1 (Never or very rarely true) to 5 (Very often or always true), with higher scores indicating higher experience of mindfulness. Total scores range from 39 to 195 and facet scores from 8 to 40 (Non-reactivity 7-35), with higher scores indicating greater mindfulness.
Time frame: 3 weeks (Timepoints: Pre Lab Visit 1, Pre Lab Visit 2, 1 week follow-up)
Difficulties in Emotion Regulation 16 Item Version (DERS-16)
The DERS-16 is a 16-item self-report scale designed to assess emotional dysregulation on a 5-point Likert scale. The scale assesses 6 aspects of emotional dysregulation: non-acceptance of emotional responses ("When I'm upset, I become embarrassed for feeling that way"), difficulties engaging in goal directed behavior ("When I'm upset, I have difficulty thinking about anything else"), impulse control difficulties ("When I'm upset, I lose control over my behaviors"), lack of emotional awareness ("When I'm upset, I take time to figure out what I'm really feeling (reverse-scored)", limited access to emotion regulation strategies ("When I'm upset, it takes me a long time to feel better"), and lack of emotional clarity ("I have no idea how I am feeling"). Total scores range from 16 to 80 and higher scores indicating greater difficulties in emotion regulation.
Time frame: 3 weeks (Timepoints: Pre Lab Visit 1, Pre Lab Visit 2, 1 week follow-up)
Respiration Rate (RR)
Respiration Rate (RR) will be measured using a Movesense MD device. Respiration rate will be assessed using a respiration belt that participants will wear around their midsection above their clothes. The belt measures air compression in a tube as participants breath in and out, moving their midsection. The pressure change is converted by a pressure transducer to a signal for the RAVANS algorithm to trigger stimulation by the UROstim device that is timed with the exhale. There is no minimum or maximum for this measurement.
Time frame: 2 weeks (Timepoints: Pre Lab Visit 1, Pre Lab Visit 2)
Penn Alcohol Craving Scale (PACS):
The Penn Alcohol Craving Scale (PACS) is a 5-item questionnaire that measures an individual's craving to drink alcohol in the past week (assessing frequency, intensity, and duration of craving, ability to resist drinking, and overall craving). Each item is scored 0-6 and total scores ranging from 0 to 30, where higher scores indicate greater craving.
Time frame: 3 weeks (Timepoints: Pre Lab Visit 1, Pre Lab Visit 2, 1 week follow-up)
Mindfulness Practice
This 2-item questionnaire assesses minutes of mindfulness practice per day. Item 1: How many minutes of practice with the recording provided by the study. Item 2: How many minutes of practice with any other meditation sources. Score can range from 0-120, and higher scores indicate more mindfulness practice.
Time frame: 2 weeks (Timepoints: Daily during intervention week-- 7 timepoints)
Plan to share: No — There is currently no plan to make individual participant data available to other researchers.
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Cambridge Health Alliance