Exploring the Effects of Brief Mindfulness Training With Vagal Nerve Stimulation on Alcohol Cue Reactivity Among Young Adult Heavy Drinkers

NCT07516873 | Recruiting

• 1 other identifier: CHA-IRB-24-25-409
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Heavy Drinking

Keywords

Heavy Drinking; Mindfulness; Vagus Nerve Stimulation; Alcohol Cue Reactivity; Heart Rate Variability

Outcome Measures

Primary Outcomes (3)

• 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.

  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).

  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.

  2 weeks (Timepoints: During Lab Visit 1 and Lab Visit 2)

Secondary Outcomes (3)

• Acceptability Measure

  3 weeks (Timepoint: 1-week follow-up)

• The International Positive and Negative Affect Schedule Short Form (I-PANAS-SF)

  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

  3 weeks (Timepoints: Screening, Lab Visit 1, Lab Visit 2, 1 week follow-up)

Other Outcomes (7)

• Alcohol Urge Questionnaire (AUQ)

  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)

  3 weeks (Timepoints: Pre Lab Visit 1, Pre Lab Visit 2, 1 week follow-up)

• Five Facet Mindfulness Questionnaire (FFMQ)

  3 weeks (Timepoints: Pre Lab Visit 1, Pre Lab Visit 2, 1 week follow-up)

Study Arms (2)

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.

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.

Behavioral: Brief Mindfulness-Based Intervention

Interventions

Active RAVANS DEVICE

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.

Active RAVANS

Brief Mindfulness-Based Intervention BEHAVIORAL

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.

Active RAVANS; Inactive RAVANS

Eligibility Criteria

• Age: 21 Years - 29 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Cambridge Health Alliance: lead

Study Sites (1)

Center for Mindfulness and Compassion

Malden, Massachusetts, 02148, United States

RECRUITING

Study Officials

• Zev Schuman-Olivier, MD

  Cambridge Health Alliance

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Frannie Marin, BS

CONTACT

(617)-643-8770; fmarin@challiance.org

Michael Datko, PhD

CONTACT

mdatko@challiance.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be blinded to their randomization status. All other study personnel will remain unblinded so that they can administer the active or inactive stimulation and address any technical issues or other concerns that may arise around the use of the RAVANS device.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 1, 2026
• First Posted: April 8, 2026
• Study Start: March 6, 2026
• Primary Completion: August 1, 2026
• Study Completion: August 1, 2026
• Last Updated: May 12, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)