Phase 1
N=19
Non-invasive Vagal Nerve Stimulation in Alcohol Use Disorder
Alcohol Use Disorder
Bottom Line
View on ClinicalTrials.gov: NCT05226130 ↗Enrolled (actual)
19
Serious AEs
0.0%
Results posted
Jul 2025
Primary outcome: Primary: Treatment Acceptability Questionnaire (TAQ) — 5.7; 6.4 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Cervical transcutaneous vagus nerve stimulation (active comparator) (Device); Cervical transcutaneous vagus nerve stimulation (sham comparator) (Device)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- Male
- Sponsor
- VA Office of Research and Development
- Primary completion
- May 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Treatment Acceptability Questionnaire (TAQ) |
5.7; 6.4 | — |
| PRIMARY Measurement of Feasibility - Recruitment Goal (Data Reflects the Number of Participants Who Were Successfully Enrolled in the Study) |
9; 10 | — |
| PRIMARY Measurement of Feasibility - Treatment Adherence (Number of Times Subjects Self-administered nVNS/Sham Stimulation for 7 Days as Instructed) |
94.4; 79.76 | — |
| PRIMARY Measurement of Feasibility - Subject Retention (Number/Percentage of Subjects Who Return for a Follow-up Visit) |
9; 9 | — |
| PRIMARY Measurement of Feasibility - Serious Adverse Side Effects |
0; 0 | — |
| SECONDARY Substance Use Recovery Evaluator (SURE) |
44.7; 44.0; 50.6; 44.9 | — |
| SECONDARY WHO Quality of Life Assessment (WHOQOL-BREF) - Psychological Domain |
14.2; 17.8; 16.8; 17.4 | — |
| SECONDARY Beck Anxiety Inventory (BAI) |
16.8; 17.0; 12.5; 17.6 | — |
| SECONDARY PROMIS Pain Interference |
22.4; 23.6; 20.9; 21.8 | — |
| SECONDARY Alcohol Urge Questionnaire (AUQ) |
25.6; 25.7; 18.4; 21.2 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Veteran
- Male subjects between 21 and 65 years of age
- Current DSM-5 diagnosis of AUD with at least one functional disability due to alcohol use, current alcohol craving, and current heavy drinking (>4 drinks on any day or >14 drinks per week)
- Able to forgo consumption of alcohol for 24 hours without any serious discomfort including nausea/vomiting, visual/auditory/tactile hallucinations, or non-essential tremor
Exclusion Criteria
- Clinical Institute Withdrawal Assessment of Alcohol Scale (CiWA) score >=9 on the day of the scan (symptoms judged to be due to co-existing anxiety or headache disorders will not be counted toward the total).
- Currently or recently (within last 90 days) enrolled in abstinence-based treatment program.
- Evidence of a maladaptive pattern of substance use or abuse other than alcohol one month prior to screening visit.
- Severe mental illness, e.g., psychosis or bipolar disorder
- At risk for suicide or homicide
- History of neurological disorder that might be associated with cognitive dysfunction.
- History of head trauma involving loss of consciousness >24 hours
- Clinically significant uncontrolled/unstable medical illness or clinically significant surgery within 1 month of the screening visit.
- MRI-related exclusion criteria: cardiac pacemaker, metal fragments in eyes/skin/body, aortic/aneurysm clips, heart-valve replacement, copper intrauterine device, shunt (ventricular or spinal), neuro/bio-stimulators
- Vagus nerve stimulation related criteria: history of carotid endarterectomy, severe carotid artery disease (e.g., history of transient ischemic attack (TIA) or stroke], congestive heart failure, cardiac arrhythmia, known severe coronary artery disease or recent myocardial infarction (within 5 years), history of seizure or syncope (within past year), prior neck surgery.
Data sourced from ClinicalTrials.gov (NCT05226130). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.