Actively Recruiting
Non-invasive Vagal Nerve Stimulation as Novel Treatment to Improve Functional Outcomes in Veterans With Alcohol Use Disorder
Led by VA Office of Research and Development · Updated on 2026-03-23
80
Participants Needed
1
Research Sites
243 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Alcohol use disorder (AUD) is a major health concern amongst Veterans as it causes functional impairments and decreased quality of life. Current AUD treatments show limited effectiveness in reducing withdrawal-related psychological and physical distress, which drives the urge to drink to relieve these symptoms. The investigators propose the vagus nerve, which is the primary nerve of the "rest and digest" branch of the autonomic nervous system via its bidirectional connections between the brain and the body, as a novel treatment target for AUD. The goal of this study is to assess treatment efficacy and mechanism of action. Noninvasive neuromodulation technologies offer the possibility for innovative, low risk treatments to support the rehabilitation and community reintegration of Veterans with AUD.
CONDITIONS
Official Title
Non-invasive Vagal Nerve Stimulation as Novel Treatment to Improve Functional Outcomes in Veterans With Alcohol Use Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Veterans aged 21 to 65 years, any race or ethnicity
- Current diagnosis of moderate or severe alcohol use disorder with at least one functional disability due to alcohol use
- Current alcohol craving and heavy drinking (5+ drinks for men, 4+ drinks for women on the same occasion, on 5 or more days in the past month)
- Mild to moderate withdrawal symptoms during abstinence
- Able to abstain from alcohol for 12-24 hours without serious discomfort or complications
- Able to comply with study procedures and speaks English
- Able to provide written informed consent
- Willing and able to self-administer vagus nerve stimulation or sham device twice daily for 7 days and attend follow-up visit
You will not qualify if you...
- Clinical Institute Withdrawal Assessment of Alcohol Scale score greater than 10 on the day of the scan
- Severe complications from alcohol withdrawal in past 6 months (seizures, hallucinations, delirium tremens)
- Currently or recently (within 90 days) in abstinence-based treatment program
- Substance use disorder other than alcohol within 1 month before screening
- Severe uncontrolled psychiatric disorders with psychotic symptoms or cognitive impairment (PTSD allowed)
- At risk for suicide or homicide requiring urgent care
- History of neurological disorder linked to cognitive dysfunction
- History of head trauma with loss of consciousness over 24 hours
- Unstable or uncontrolled medical illness or recent significant surgery within 1 month
- MRI contraindications such as pacemaker, metal implants, pregnancy, or nursing
- Certain vagus nerve stimulation-related risks including implanted devices, neck metal implants, carotid artery disease, or serious heart conditions
- Unstable pharmacotherapy for alcohol use disorder (less than 2 weeks stability)
- Current use of opioids or benzodiazepines
- Need for higher level of care during study participation as determined by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
VA San Diego Healthcare System, San Diego, CA
San Diego, California, United States, 92161-0002
Actively Recruiting
Research Team
R
Ruth Klaming, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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