Status:
COMPLETED
Non-invasive Vagal Nerve Stimulation in Alcohol Use Disorder
Lead Sponsor:
VA Office of Research and Development
Conditions:
Alcohol Use Disorder
Eligibility:
MALE
21-65 years
Phase:
PHASE1
Brief 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 o...
Detailed Description
AUD is a serious mental health disorder that affects more than 40% of US military Veterans, presenting a major burden to this population. Relapse rates of AUD are extremely high; over half of Veterans...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 2 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2024
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT05226130
Start Date
May 2 2022
End Date
May 1 2024
Last Update
July 3 2025
Active Locations (1)
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1
VA San Diego Healthcare System, San Diego, CA
San Diego, California, United States, 92161-0002