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Study on Mindfulness and Vagal Nerve Stimulation for Heavy Drinking

This study is exploring if a brief mindfulness training combined with a device called RAVANS can help young adults who drink heavily. RAVANS uses gentle electrical pulses to a nerve in your ear (vagal nerve stimulation) during breathing out, which may help calm your body. The mindfulness training involves practicing meditation for 10 minutes daily for a week. Researchers want to see if these interventions can improve how your heart rate recovers from stress and reduce alcohol cravings. You might be able to join if you are 21-29 years old, live in Massachusetts, and drink more than 14 alcoholic drinks per week or at least 5 drinks on one day per week. The study aims to enroll 50 participants to understand if these approaches are acceptable and practical.

Study design
This is an interventional study with 50 participants. All participants will receive a brief mindfulness intervention, and some will also receive active RAVANS while others receive inactive RAVANS.
What's involved
You will complete an online survey, attend two in-person lab visits about one week apart, and have a final virtual follow-up visit one week after the second lab visit.
Compensation
Not stated in the trial record.
Follow-up
Participants will have a final virtual follow-up visit one week after their second lab visit.

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NCT07516873

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

Recruiting
NAAges 21–29Interventional
Cambridge Health Alliance
~50 participants
Updated 2026-05-12 on ClinicalTrials.gov
What's tested:Active RAVANSBrief Mindfulness-Based Intervention

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
RAVANS Effect on HRV Recovery
Measured over 2 weeks (Timepoints: During Lab Visit 1 and Lab Visit 2)
+2 more outcomes measured

Conditions

Heavy Drinking

Explore related trials

Heavy Drinking

Where it's being run

1 sites across 1 states
Massachusetts1

Study leadership

  • Zev Schuman-Olivier, MD · PRINCIPAL_INVESTIGATOR · Cambridge Health Alliance

Who to contact

Frannie Marin, BS
[email protected]
(617)-643-8770
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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).

What this trial measures

  • RAVANS Effect on HRV Recovery2 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 Recovery2 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 Cues2 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.