RecruitingNot ApplicableNCT07516873

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

Exploring the Feasibility and Acceptability of Brief Mindfulness Training With Vagal Nerve Stimulation for Reducing Alcohol Consumption Among Young Adults

Sponsor

Cambridge Health Alliance

Enrollment

50 participants

Start Date

Mar 6, 2026

Study Type

INTERVENTIONAL

Conditions

Heavy Drinking

Summary

In the present study, we 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 durvey data will be collected to assess the impact of the intervention on autonomic regulation, alcohol consumption, and additional clinical measures.

Eligibility

Min Age: 21 YearsMax Age: 29 Years

Inclusion Criteria6

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 Criteria18

Current or past diagnosis of a substance use disorder based on the Quick Structured Clinical Interview for DSM-5 Module C (Substance Use Disorders).
Active prescription for sedative/hypnotics, opioids, or anesthetic medications.
Active prescription for medications used to treat 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).

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Interventions

DEVICEActive 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.

BEHAVIORALBrief 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.