Non-invasive Vagal Nerve Stimulation for Alcohol Use Disorder in Veterans
This study is testing a new way to help Veterans with Alcohol Use Disorder (AUD). It uses a device called cervical transcutaneous vagus nerve stimulation (nVNS), which sends a low-voltage electrical signal to a nerve in your neck. This nerve, called the vagus nerve, helps control your body's 'rest and digest' functions and may help reduce stress and the urge to drink. Researchers want to see if this stimulation can improve symptoms like anxiety, withdrawal, and alcohol cravings. You might be able to join if you are a Veteran between 21 and 65 years old with a moderate or severe AUD diagnosis and current heavy drinking. The study aims to enroll 80 participants.
- Study design
- This interventional study will enroll 80 participants and compares active cervical transcutaneous vagus nerve stimulation to a sham (inactive) device.
- What's involved
- Participants will self-administer the device twice daily. Measurements for anxiety, withdrawal, and alcohol urge will be taken at the start, after one week of intervention, and one month later.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for one month after the intervention period.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Non-invasive Vagal Nerve Stimulation as Novel Treatment to Improve Functional Outcomes in Veterans With Alcohol Use Disorder
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Ruth Klaming, PhD · PRINCIPAL_INVESTIGATOR · VA San Diego Healthcare System, San Diego, CA
Who to contact
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What this trial measures
- Hamilton Anxiety Rating Scale (HAM-A)Baseline to week 1 and 1 month post baseline of 2x daily intervention
The HAM-A is a 14-item scale that assesses the presence and severity of psychological distress and negative emotional states. Completion takes 10 minutes. This instrument is widely used in clinical trials and alcohol studies and is sensitive to both nVNS and AUD treatment. Items are rated on a scale ranging from 0 (not present) to 4 (very severe).
- Clinical Institute Withdrawal Assessment of Alcohol Scale, Revised (CIWA-Ar)Baseline to week 1 and 1 month post baseline of 2x daily intervention
The Clinical Institute Withdrawal Assessment of Alcohol Scale, Revised (CIWA-Ar) is a short form (5 min.) to assess symptoms of acute alcohol withdrawal and physical discomfort. The CIWA-Ar includes 8 items, 7 of which are rated from 1 to 7 (higher score indicating higher severity) and 1 of which is rated from 0 to 4 (higher score indication less orientation to place/or person)
- Alcohol Urge Questionnaire (AUQ)Baseline to week 1 and 1 month post baseline of 2x daily intervention
The Alcohol Urge Questionnaire (AUQ) is 8-item scale that measures cognitive preoccupation with alcohol on a 7-point rating scale ranging from "strongly disagree" to "strongly agree". Two items are reverse scored. Higher scores reflect greater craving.
- WHO Quality of Life assessment (WHOQOL-BREF)Baseline to week 1 and 1 month post baseline of 2x daily intervention
The WHOQOL-BREF assesses quality of life across four domains (physical health, psychological, social relationships, and environment) with a total of 26 questions. The WHOQOL-BREF is a widely used instrument with strong psychometric properties.