NCT07516873 Exploring the Effects of Brief Mindfulness Training With Vagal Nerve Stimulation on Alcohol Cue Reactivity Among Young Adult Heavy Drinkers
| NCT ID | NCT07516873 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Cambridge Health Alliance |
| Condition | Heavy Drinking |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2026-03-06 |
| Primary Completion | 2026-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2026-03-06 with a primary completion date of 2026-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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).
Contact & Investigator
Zev Schuman-Olivier, MD
PRINCIPAL INVESTIGATOR
Cambridge Health Alliance
Frequently Asked Questions
Who can join the NCT07516873 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, up to 29 Years, studying Heavy Drinking. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07516873 currently recruiting?
Yes, NCT07516873 is actively recruiting participants. Contact the research team at fmarin@challiance.org for enrollment information.
Where is the NCT07516873 trial being conducted?
This trial is being conducted at Malden, United States.
Who is sponsoring the NCT07516873 clinical trial?
NCT07516873 is sponsored by Cambridge Health Alliance. The principal investigator is Zev Schuman-Olivier, MD at Cambridge Health Alliance. The trial plans to enroll 50 participants.