Could a zap to the vagus nerve curb alcohol cravings in veterans?
NCT ID NCT06399653
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a non-invasive device that gently stimulates the vagus nerve can reduce withdrawal symptoms, anxiety, and cravings in 80 veterans with moderate-to-severe alcohol use disorder. Participants will receive the stimulation and complete questionnaires and a brain scan task. The goal is to see if this low-risk approach can improve quality of life and help veterans regain control.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 80 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2025
- Expected to finish
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Aug 2029
An estimate. End dates often move.
- Lead sponsor
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A government agency
The lead sponsor is a US federal agency other than the NIH.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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21 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Veterans between 21 and 65 years, any race or ethnicity. 2. Meet current DSM-5 diagnosis of moderate or severe AUD (Structured Clinical Interview for DMS-5 (SCID) interview) with at least one functional disability due to alcohol use, current alcohol craving, and current heavy drinking (\>= 5 drinks (men) / \>= 4 drinks (women) on the same occasion, on 5 or more days in the past month) as defined by the Substance Abuse and Mental Health Services Administration (SAMHSA), and mild to moderate withdrawal symptoms during abstinence. 3. Able to forgo consumption of alcohol for 12-24 hours without any serious discomfort or complications. 4. Capable of complying with study schedule, procedures, and speaks English. 5. Able to provide voluntary written informed consent prior to initiation of visit 1. 6. Able and willing to self-administer nVNS/sham stimulation as instructed for the duration of the study, and willing to commit to the return visit at the end of the study. Exclusion Criteria: 1. Clinical Institute Withdrawal Assessment of Alcohol Scale (CIWA-Ar) score \>10 on the day of the scan (symptoms judged to be due to co-existing anxiety or headache disorders will not be counted toward the total). 2. Recent history past 6 months) of severe complications due to alcohol withdrawal (alcohol withdrawal seizures, hallucinations/illusions, delirium tremens). 3. Currently or recently (within last 90 days) enrolled in abstinence-based treatment program. 4. Evidence of a maladaptive pattern of substance use or abuse other than alcohol one month prior to screening visit. 5. Uncontrolled severe psychiatric disorder with psychotic symptoms or cognitive impairment. We will not exclude for PTSD. 6. At risk for suicide requiring urgent higher-level care or homicide (based on the Columbia-Suicide Severity Rating Scale and follow-up clinical interview). 7. History of neurological disorder that might be associated with cognitive dysfunction. 8. History of head trauma involving loss of consciousness \>24 hours 9. Clinically significant uncontrolled/unstable medical illness or clinically significant surgery within 1 month of the screening visit. 10. MRI-related exclusion criteria: cardiac pacemaker, metal fragments in eyes/skin/body, aortic/aneurysm clips, heart-valve replacement, copper intrauterine device, shunt (ventricular or spinal), neuro/bio-stimulators, (for females) pregnant or nursing. Any implants will be reviewed for safety. 11. Vagus nerve stimulation related criteria: active implantable medical device, metallic device implanted at or near the neck, carotid atherosclerosis (narrowing of arteries), cervical vagotomy, clinically significant hypertension, hypotension, bradycardia, or tachycardia, cardiac disease and atherosclerotic cardiovascular disease (severe carotid artery disease (e.g., history of transient ischemic attack (TIA) or stroke), congestive heart failure, severe coronary artery disease or recent myocardial infarction (within 5 years)). 12. Pharmacotherapy for AUD: \>= 2 weeks stability is required to ensure a steady state of medication effects prior to nVNS administration. 13. Currently taking opioids or benzodiazepines. 14. In case it is determined by the investigator during the course of the study, that a subject needs a higher level or care, study participation will be discontinued, and the subject will be excluded from the study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
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Contacts and locations
Locations
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VA San Diego Healthcare System, San Diego, CA
RECRUITINGSan Diego, California, 92161-0002, United States
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