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

NCT07516873 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-05-12

No results posted yet for this study

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

Interventions

DEVICE

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.

BEHAVIORAL

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.

Sponsors & Collaborators

  • Cambridge Health Alliance

    lead OTHER

Principal Investigators

  • Zev Schuman-Olivier, MD · Cambridge Health Alliance

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
29 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-06
Primary Completion
2026-08-31
Completion
2026-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07516873 on ClinicalTrials.gov