Actively Recruiting
Exploring the Feasibility and Acceptability of Brief Mindfulness Training With Vagal Nerve Stimulation for Reducing Alcohol Consumption Among Young Adults
Led by Cambridge Health Alliance · Updated on 2026-05-12
50
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the acceptability and feasibility of a brief mindfulness intervention combined with Respiratory-gated Auricular Vagal Afferent Nerve Stimulation (RAVANS) to help young adults who are heavy drinkers reduce their alcohol consumption. The study focuses on young adults aged 21 to 29 who consume high amounts of alcohol. Researchers will assess how these interventions affect autonomic nervous system regulation, alcohol use, and other clinical outcomes using heart rate variability and self-report surveys. Participants will first complete a one-week mindfulness practice involving daily 10-minute audio meditations. They will then attend two in-person lab visits spaced one week apart. During these visits, participants will be randomly assigned to receive either active or inactive (sham) RAVANS device stimulation. Lab visits include surveys, heart rate variability measurements, exposure to alcohol-related visual cues, and sessions involving the RAVANS device alongside mindful breathing exercises. The active RAVANS delivers nerve stimulation linked to breathing, while the inactive version looks identical but does not provide electrical pulses. Throughout the study, participants will complete surveys online at baseline, during lab visits, and in a final virtual follow-up one week after the second lab visit. Heart rate variability will be monitored using wearable ECG sensors during resting periods and cue exposure tasks. Researchers will evaluate responses to alcohol-related stimuli and the impact of mindfulness and nerve stimulation on autonomic function. The total involvement spans approximately three weeks, including remote and in-person visits, with ongoing safety and acceptability assessments.
CONDITIONS
Brief 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 to 29 years old
- Consume more than 14 standard drinks per week OR at least 5 drinks in one day per week (past 30 days)
- Sufficient English fluency to understand procedures and questionnaires
- Capacity and ability to provide informed consent
- Score at least 15 points on the PACS at screening (10-14 points require additional review)
You will not qualify if you...
- Current or past diagnosis of substance use disorder based on DSM-5 Module C
- Active prescription for sedative/hypnotics, opioids, or anesthetic medications
- Active prescription for medications to treat alcohol use disorder (e.g., naltrexone, disulfiram, acamprosate)
- Active psychosis or schizophrenia-spectrum disorder diagnosis
- Bipolar I disorder history 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
- Participation in another experimental intervention study
- Current daily mindfulness practice over 10 minutes per day
- Participation in an 8-week intensive mindfulness intervention or meditation retreat in past 3 years
- Expected medical hospitalization in next 2 months or current pregnancy
- Expected incarceration in next 2 months
- Presence of electronic implants such as pacemakers, defibrillators, or pumps
- Presence of cardiac rhythm disorder
- History of seizures
- Presence of skin disorders or malignant diseases around the left ear
- Lack of alcohol craving as assessed by PACS (score < 10 points)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment call (virtual)
Duration - 1 week
Participants practice daily mindfulness meditation using a 10-minute audio meditation on 6 out of 7 days between lab visits.
No visits; daily home practice
Duration - 1 day
Participants complete surveys, heart rate variability measurements, a drinking-related stimuli exposure task, and a 20-minute device fit test followed by a 10-minute active or inactive RAVANS session.
1 in-person lab visit
Duration - 1 day
Participants complete surveys, heart rate variability measurements, a 30-minute active or inactive RAVANS session with mindful breathing, and a 5-minute device session while viewing alcohol-related cues.
1 in-person lab visit approximately 1 week after Lab Visit 1
Duration - 30 to 45 minutes
Participants complete final surveys via a virtual visit approximately 1 week after Lab Visit 2, marking the end of study activities.
1 virtual follow-up visit
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
M
Michael Datko, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here