Exploring the Effects of Brief Mindfulness Training With Vagal Nerve Stimulation on Alcohol Cue R… (NCT07516873) | Clinical Trial Compass
RecruitingNot Applicable
Exploring the Effects of Brief Mindfulness Training With Vagal Nerve Stimulation on Alcohol Cue Reactivity Among Young Adult Heavy Drinkers
United States50 participantsStarted 2026-03-06
Plain-language summary
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.
Who can participate
Age range
21 Years – 29 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* Current or past diagnosis of a substance use disorder based on the Quick Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) Module C (Substance Use Disorders).
* Active prescription for sedative/hypnotics, opioids, or anesthetic medications.
* Active prescription for medications used to treat alcohol use disorder (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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
RAVANS Effect on HRV Recovery
Timeframe: 2 weeks (Timepoints: During Lab Visit 1 and Lab Visit 2)
2
Mindfulness Effect on HRV Recovery
Timeframe: 2 weeks (Timepoints: During Lab Visit 1 and Lab Visit 2)
3
RAVANS Effect on HRV Response to Cues
Timeframe: 2 weeks (Timepoints: During Lab Visit 1 and Lab Visit 2)