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NCT05226130 · ClinicalTrials.gov registry record · Phase 1
Non-invasive Vagal Nerve Stimulation in Alcohol Use Disorder
A Phase 1 study, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- Phase 1
- Development phase
- 19
- Enrollment target
NCT05226130: Completed Phase 1 study, sponsored by VA Office of Research and Development.
NCT05226130 is a Phase 1 study that has completed, run by VA Office of Research and Development. The registered enrollment target is 19 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05226130, a Phase 1 study, has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 19 participants
- Enrollment target
Study Summary
Alcohol use disorder (AUD) is a major health concern amongst Veterans as it causes poor health, lost days at work, impaired psychosocial functioning, and decreased quality of life. Current treatment options for AUD show limited effectiveness, which is exemplified by high relapse rates. Chronic heavy drinking results in psychological and physical distress during abstinence, including anxiety, irritability, and general discomfort, which increases the urge to drink to relieve these symptoms. The hypothesis of this study is that noninvasive vagal nerve stimulation (nVNS) can modify the perception of such inner bodily sensations of distress, and consequently reduces the drive to drink for relief. The aim of this study is to establish feasibility and acceptability of applying nVNS as a rehabilitative treatment for AUD in Veterans. The study will also evaluate the effect of nVNS on functional outcomes, quality of life, distress, and craving, and if nVNS alters neural activation patterns in brain regions involved in the perception and awareness of distress and pain.
Primary Outcome
The Treatment Acceptability Questionnaire (TAQ) is a self-rating questionnaire used to assess acceptability of a treatment. The TAQ uses a 7-point rating scale ranging from 1 to 7, with lower scores reflecting lower acceptability and a midpoint of 4 indicating neutral acceptability. A rating above the midpoint of the TAQ (i.e., score between 5 and 7) is the established criterion for "acceptable to highly acceptable".
Interventions
- DEVICE Cervical transcutaneous vagus nerve stimulation (active comparator)
- DEVICE Cervical transcutaneous vagus nerve stimulation (sham comparator)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2022-05-02 |
| Est. Completion | 2024-05-01 |
| Phase | Phase 1 |
What the finished NCT05226130 record still lists
NCT05226130 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (68% lower).
The record links to 0 conditions, and to 2 interventions - of which Cervical transcutaneous vagus nerve stimulation (active comparator) is the first listed.
NCT05226130 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05226130 about?
NCT05226130 is a clinical study titled "Non-invasive Vagal Nerve Stimulation in Alcohol Use Disorder". Alcohol use disorder (AUD) is a major health concern amongst Veterans as it causes poor health, lost days at work, impaired psychosocial functioning, and decreased quality of life. Current treatment options for AUD show limited effectiveness, which is exemplified by high relapse rates. Chronic heavy...
What is the current status of trial NCT05226130?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 19 participants. The study started on 2022-05-02. Estimated completion is 2024-05-01.
What interventions are being tested in trial NCT05226130?
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 NCT05226130?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05226130's enrollment target sits among peer trials
19 1716th of 2000 higher than 281 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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