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

Part of paid clinical trials in Malden, Massachusetts.

Sponsor
Cambridge Health Alliance
Study ID
NCT07516873
Status
Recruiting
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Conditions

  • Heavy Drinking

Eligibility Criteria

Sex
ALL
Age
21 Years - 29 Years
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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 Dates

Start date
Mar 6, 2026
Status verified
May 2026
Primary completion
Aug 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Center for Mindfulness and CompassionMaldenMassachusetts02148-

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Center for Mindfulness and Compassion· Malden, MA

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