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NCT06399653 · ClinicalTrials.gov registry record · NA
Non-invasive Vagal Nerve Stimulation as Novel Treatment to Improve Functional Outcomes in Veterans With Alcohol Use Disorder
A NA study of Alcohol Use Disorder, sponsored by VA Office of Research and Development.
- Recruiting
- Registry status
- NA
- Development phase
- 80
- Enrollment target
- 1
- Study location
NCT06399653: Recruiting NA study of Alcohol Use Disorder, sponsored by VA Office of Research and Development.
NCT06399653 is a NA study of Alcohol Use Disorder that is actively recruiting participants, run by VA Office of Research and Development. The registered enrollment target is 80 participants, below the 328-participant average among 184 other Alcohol Use Disorder trials with a reported enrollment target (76% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06399653, a NA study of Alcohol Use Disorder, is actively recruiting participants, sponsored by VA Office of Research and Development.
- RECRUITING
- Registry status
- NA
- Development phase
- 80 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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).
Conditions Studied
Interventions
- DEVICE Cervical transcutaneous vagus nerve stimulation (active comparator)
- DEVICE Cervical transcutaneous vagus nerve stimulation (sham comparator)
Study Locations (1)
California
- VA San Diego Healthcare System, San Diego, CA - San Diego
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2025-01-01 |
| Est. Completion | 2029-08-31 |
| Phase | NA |
What NCT06399653 shows while recruiting
NCT06399653 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 328-participant average among 184 other Alcohol Use Disorder trials with a reported enrollment target (76% lower).
The record links to 1 condition, with Alcohol Use Disorder appearing as the primary indexed condition, and to 2 interventions - of which Cervical transcutaneous vagus nerve stimulation (active comparator) is the first listed.
NCT06399653 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT06399653 about?
NCT06399653 is a clinical study titled "Non-invasive Vagal Nerve Stimulation as Novel Treatment to Improve Functional Outcomes in Veterans With Alcohol Use Disorder". 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 the...
What is the current status of trial NCT06399653?
This trial is currently recruiting. It is a NA study. The enrollment target is 80 participants. The study started on 2025-01-01. Estimated completion is 2029-08-31.
What conditions does trial NCT06399653 study?
This clinical trial studies the following conditions: Alcohol Use Disorder.
What interventions are being tested in trial NCT06399653?
The interventions under investigation include: Cervical transcutaneous vagus nerve stimulation (active comparator) (DEVICE), Cervical transcutaneous vagus nerve stimulation (sham comparator) (DEVICE).
Who is sponsoring clinical trial NCT06399653?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06399653 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Alcohol Use Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06399653's enrollment target sits among peer trials
80 100th of 184 higher than 79 of 184 other Alcohol Use Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Alcohol Use Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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