Recruiting

RAVANS

Sponsor:

Cambridge Health Alliance

Code:

NCT07516873

Conditions

Heavy Drinking

Eligibility Criteria

Sex: All

Age: 21 - 29

Healthy Volunteers: Not accepted

Interventions

Active RAVANS

Brief Mindfulness-Based Intervention

Study Details

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

Study ID

NCT07516873

Start date

Mar 6, 2026

Status verified date

May, 2026

Completion date

Aug, 2026

Anticipated

Primary completion date

Aug, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 29

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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).

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Active RAVANS

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.

sham comparator: Inactive RAVANS

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.

Interventions

Active RAVANS

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 Intervention

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.

Primary outcome measure

  • RAVANS Effect on HRV Recovery [ Time Frame: 2 weeks (Timepoints: During Lab Visit 1 and Lab Visit 2) ]
  • Mindfulness Effect on HRV Recovery [ Time Frame: 2 weeks (Timepoints: During Lab Visit 1 and Lab Visit 2) ]
  • RAVANS Effect on HRV Response to Cues [ Time Frame: 2 weeks (Timepoints: During Lab Visit 1 and Lab Visit 2) ]

Central Contacts and Locations

Central contacts

Frannie Marin, BS

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

Michael Datko, PhD

mdatko@challiance.org

Locations

Center for Mindfulness and Compassion

Recruiting

Malden, Massachusetts, United States, 02148

More Information

Sponsor

Cambridge Health Alliance

Last update posted

May 12, 2026

Last verified

May, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Cambridge Health Alliance on 2026-05-12.