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

Recruiting now · Not applicable

Conditions studied: Heavy Drinking

In brief

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.

Key facts

Study ID

NCT07516873

Run by

Cambridge Health Alliance

People needed

50

Starts

2026-03-06

Expected to finish

2026-08-01

Last updated by the study team

2026-05-12

Who can join

Age: 21 and older, up to 29. Sex: any. Healthy volunteers: not accepted.

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.
• 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).

Where it is running

• Center for Mindfulness and Compassion — Malden, Massachusetts, United States (enrolling)

Full record on ClinicalTrials.gov

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