Vagus Nerve Stimulation for Alcoholism

Recruiting in Palo Alto (17 mi)

Overseen byRuth Klaming, PhD

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: VA Office of Research and Development

Trial Summary

What is the purpose of this trial?This trial is testing a new treatment called noninvasive vagal nerve stimulation (nVNS) for Veterans with Alcohol Use Disorder. The treatment aims to reduce anxiety and cravings by sending gentle electrical signals to a nerve in the neck. Researchers hope this will help Veterans who struggle with current treatments and improve their quality of life. Noninvasive vagus nerve stimulation (nVNS) is a recently released therapy that has been explored for conditions like cluster headaches and epilepsy.

Eligibility Criteria

This trial is for male Veterans aged 21-65 with Alcohol Use Disorder (AUD) who drink heavily and have at least one disability due to alcohol use. They must be able to stop drinking for a day without severe withdrawal symptoms. Excluded are those with neurological issues, recent abstinence treatment, unstable medical conditions, certain MRI contraindications, or severe mental illness.

Inclusion Criteria

Current DSM-5 diagnosis of AUD with at least one functional disability due to alcohol use, current alcohol craving, and current heavy drinking (>4 drinks on any day or >14 drinks per week)

I am a man aged between 21 and 65.

Able to forgo consumption of alcohol for 24 hours without any serious discomfort including nausea/vomiting, visual/auditory/tactile hallucinations, or non-essential tremor

+1 more

Exclusion Criteria

I haven't had major surgery or uncontrolled illness in the last month.

I have a history of heart issues, stroke, seizures, or neck surgery.

History of head trauma involving loss of consciousness >24 hours

+7 more

Participant Groups

The study tests non-invasive vagal nerve stimulation (nVNS) as a potential treatment for AUD in Veterans. It compares active nVNS against sham (fake) nVNS to see if it can reduce distress and the urge to drink by affecting brain regions related to distress perception.

2Treatment groups

Active Control

Placebo Group

Group I: Active cervical transcutaneous vagus nerve stimulationActive Control1 Intervention

Participants will be assigned to active transcutaneous vagus nerve stimulation, received once during each of the study visits and self-administered twice a day for a week.

Group II: Sham cervical transcutaneous vagus nerve stimulationPlacebo Group1 Intervention

Participants will be assigned to sham transcutaneous vagus nerve stimulation, received once during each of the study visits and self-administered twice a day for a week.