Non-invasive Vagal Nerve Stimulation as Novel Treatment to Improve Functional Outcomes in Veteran… (NCT06399653) | Clinical Trial Compass
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Non-invasive Vagal Nerve Stimulation as Novel Treatment to Improve Functional Outcomes in Veterans With Alcohol Use Disorder
United States80 participantsStarted 2025-01-01
Plain-language summary
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.
Who can participate
Age range
21 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Veterans between 21 and 65 years, any race or ethnicity.
. 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.
. Able to forgo consumption of alcohol for 12-24 hours without any serious discomfort or complications.
. Capable of complying with study schedule, procedures, and speaks English.
. Able to provide voluntary written informed consent prior to initiation of visit 1.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Hamilton Anxiety Rating Scale (HAM-A)
Timeframe: Baseline to week 1 and 1 month post baseline of 2x daily intervention
2
Clinical Institute Withdrawal Assessment of Alcohol Scale, Revised (CIWA-Ar)
Timeframe: Baseline to week 1 and 1 month post baseline of 2x daily intervention
3
Alcohol Urge Questionnaire (AUQ)
Timeframe: Baseline to week 1 and 1 month post baseline of 2x daily intervention
4
WHO Quality of Life assessment (WHOQOL-BREF)
Timeframe: Baseline to week 1 and 1 month post baseline of 2x daily intervention
. 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
. 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).
. Recent history past 6 months) of severe complications due to alcohol withdrawal (alcohol withdrawal seizures, hallucinations/illusions, delirium tremens).
. Currently or recently (within last 90 days) enrolled in abstinence-based treatment program.
. Evidence of a maladaptive pattern of substance use or abuse other than alcohol one month prior to screening visit.
. Uncontrolled severe psychiatric disorder with psychotic symptoms or cognitive impairment. We will not exclude for PTSD.
. At risk for suicide requiring urgent higher-level care or homicide (based on the Columbia-Suicide Severity Rating Scale and follow-up clinical interview).
. History of neurological disorder that might be associated with cognitive dysfunction.
. History of head trauma involving loss of consciousness \>24 hours