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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. 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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05226130
The ClinicalTrials.gov registry entry for NCT05226130 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 19 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is VA Office of Research and Development, which has 1,668 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Cervical transcutaneous vagus nerve stimulation (active comparator) is the first listed.
NCT05226130 reports 0 study locations.
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.
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