Brief mindfulness plus vagus nerve stimulation to lower alcohol cue reactivity in young heavy drinkers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.