RecruitingNot ApplicableNCT06399653

Non-invasive Vagal Nerve Stimulation as Novel Treatment to Improve Functional Outcomes in Veterans With Alcohol Use Disorder


Sponsor

VA Office of Research and Development

Enrollment

80 participants

Start Date

Jan 1, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 21 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a non-invasive device that gently stimulates the vagus nerve (a major nerve connected to the brain) through the skin of the neck can help veterans with alcohol use disorder reduce cravings and improve brain function. This is a drug-free, wearable treatment approach. **You may be eligible if...** - You are a veteran between 21 and 65 years old - You have moderate or severe alcohol use disorder and drink heavily (5+ drinks for men, 4+ for women on the same occasion, 5+ days in the past month) - You can safely go without alcohol for 12–24 hours - You can speak and read English **You may NOT be eligible if...** - You have had severe alcohol withdrawal symptoms (seizures, hallucinations, delirium) in the past 6 months - You are in an abstinence-based treatment program - You use other substances heavily - You have a severe psychiatric disorder with psychosis or significant cognitive impairment - You are at risk of suicide or violence - You have a pacemaker or certain metal implants - You currently use opioids or benzodiazepines Talk to your doctor to see if this trial is right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICECervical transcutaneous vagus nerve stimulation (active comparator)

Active nVNS produces low-voltage electrical signal that generates sensations on the skin on upper anterior cervical area (overlying carotid artery) and that stimulates the vagus nerve.

DEVICECervical transcutaneous vagus nerve stimulation (sham comparator)

Sham nVNS devices look identical to active devices and participants will undergo identical training for self-administration on upper anterior cervical area (overlying carotid artery). Sham devices do not stimulate the vagus nerve.


Locations(1)

VA San Diego Healthcare System, San Diego, CA

San Diego, California, United States

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NCT06399653


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