Actively Recruiting
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
Eligibility Criteria
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.
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
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Center for Mindfulness and Compassion
Malden, Massachusetts, United States, 02148
Actively Recruiting
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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