Brief mindfulness plus vagus nerve stimulation to lower alcohol cue reactivity in young heavy drinkers
Exploring the Feasibility and Acceptability of Brief Mindfulness Training With Vagal Nerve Stimulation for Reducing Alcohol Consumption Among Young Adults
This project will test whether a one-week mindfulness program combined with either active or inactive ear-based vagus nerve stimulation can reduce alcohol cue reactivity and drinking in 21–29-year-old heavy drinkers.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 21 Years to 29 Years |
| Sex | All |
| Sponsor | Cambridge Health Alliance Academic / other |
| Locations | 1 site (Malden, Massachusetts) |
| Trial ID | NCT07516873 on ClinicalTrials.gov |
What this trial studies
Participants complete a one-week brief mindfulness intervention and are randomized to receive active or sham respiratory-gated auricular vagal afferent nerve stimulation (RAVANS) during two in-person lab visits. The protocol collects heart rate variability during resting periods and responses to alcohol-related cues, along with self-report surveys on drinking and related symptoms. Visits include a device fit test, a drinking-related stimuli exposure task with visual cues, and follow-up surveys conducted virtually one week after the second lab visit. The trial focuses on acceptability and feasibility in a community sample recruited in Massachusetts.
Who should consider this trial
Good fit: Ideal participants are 21–29 years old, currently living in Massachusetts, meet the trial's heavy-drinking thresholds, have sufficient English fluency, and score at least 15 on the PACS at screening.
Not a fit: People with a current or past DSM-5 substance use disorder, active psychosis, those taking sedative/hypnotics, opioids, anesthetics, or medications for AUD, or those living outside Massachusetts are unlikely to qualify or benefit from this protocol.
Why it matters
Potential benefit: If successful, this approach could lower cue-triggered cravings, improve autonomic regulation, and help reduce alcohol use among young heavy drinkers.
How similar studies have performed: Prior pilot work with vagus nerve stimulation and with mindfulness separately has shown promise for reducing craving and improving heart rate variability, but combining a brief mindfulness program with RAVANS for alcohol cue reactivity is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 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).
Where this trial is running
Malden, Massachusetts
- Center for Mindfulness and Compassion — Malden, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Zev Schuman-Olivier, MD — Cambridge Health Alliance
- Study coordinator: Frannie Marin, BS
- Email: fmarin@challiance.org
- Phone: (617)-643-8770
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.