Actively Recruiting

Phase Not Applicable
Age: 21Years - 29Years
All Genders
NCT07516873

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

Led by Cambridge Health Alliance · Updated on 2026-05-12

50

Participants Needed

1

Research Sites

21 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 21Years - 29Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Currently living in Massachusetts.
  • Aged 21-29 years old.
  • Consume 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.
  • Score at least 15 points on the Penn Alcohol Craving Scale (PACS) at screening. Participants scoring 10-14 will have additional review for eligibility.
Not Eligible

You will not qualify if you...

  • Current or past diagnosis of substance use disorder per DSM-5 Module C.
  • Active prescription for sedative/hypnotics, opioids, or anesthetic medications.
  • Active prescription for medications treating alcohol use disorder (e.g., naltrexone, disulfiram, acamprosate).
  • Diagnosis of active psychosis or schizophrenia-spectrum disorder.
  • History of Bipolar I disorder or severe mania.
  • Severe symptoms of PTSD.
  • Acute suicidality or self-injurious behavior.
  • Cognitive inability to complete informed consent assessment with >90% accuracy after 2 attempts.
  • Current participation in another experimental intervention study.
  • Current daily mindfulness practice over 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 next 2 months or currently pregnant.
  • Expected incarceration in next 2 months.
  • Presence of electronic implants like pacemakers, defibrillators, or pumps.
  • Presence of cardiac rhythm disorder.
  • History of seizures.
  • Skin disorders or malignant diseases in or around left ear.
  • Lack of alcohol craving (PACS score <10) during screening.

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Center for Mindfulness and Compassion

Malden, Massachusetts, United States, 02148

Actively Recruiting

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Research Team

F

Frannie Marin, BS

CONTACT

M

Michael Datko, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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