Non-invasive vagus nerve stimulation for treating alcohol use disorder in veterans

Non-invasive Vagal Nerve Stimulation as Novel Treatment to Improve Functional Outcomes in Veterans With Alcohol Use Disorder

This study is testing if a new treatment using non-invasive vagus nerve stimulation can help veterans with alcohol use disorder by reducing their cravings and withdrawal symptoms.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 21 Years to 65 Years
• Sex: All
• Sponsor: VA Office of Research and Development (fed)
• Locations: 1 site (San Diego, California)
• Trial ID: NCT06399653 on ClinicalTrials.gov

What this trial studies

This study investigates the use of non-invasive vagus nerve stimulation (nVNS) as a treatment for alcohol use disorder (AUD) in veterans. The research aims to assess the efficacy of nVNS in reducing withdrawal-related distress and cravings, which are significant barriers to recovery. By targeting the vagus nerve, the study seeks to restore physiological balance and improve functional outcomes for veterans suffering from AUD. Participants will receive either active or sham nVNS treatment while their progress is monitored over the course of the study.

Who should consider this trial

Good fit: Ideal candidates for this study are veterans aged 21 to 65 who have a moderate to severe diagnosis of alcohol use disorder and experience functional impairments due to their condition.

Not a fit: Patients who do not meet the criteria for moderate to severe alcohol use disorder or those unable to abstain from alcohol for the required duration may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve recovery outcomes and quality of life for veterans with alcohol use disorder.

How similar studies have performed: While the use of vagus nerve stimulation is a novel approach for treating alcohol use disorder, similar neuromodulation techniques have shown promise in alleviating anxiety and depression, suggesting potential for success in this application.

Eligibility criteria

Inclusion Criteria:

1. Veterans between 21 and 65 years, any race or ethnicity.
2. Meet current DSM-5 diagnosis of moderate or severe AUD (Structured Clinical Interview for DMS-5 (SCID) interview) with at least one functional disability due to alcohol use, current alcohol craving, and current heavy drinking (\>= 5 drinks (men) / \>= 4 drinks (women) on the same occasion, on 5 or more days in the past month) as defined by the Substance Abuse and Mental Health Services Administration (SAMHSA), and mild to moderate withdrawal symptoms during abstinence.
3. Able to forgo consumption of alcohol for 12-24 hours without any serious discomfort or complications.
4. Capable of complying with study schedule, procedures, and speaks English.
5. Able to provide voluntary written informed consent prior to initiation of visit 1.
6. Able and willing to self-administer nVNS/sham stimulation as instructed for the duration of the study, and willing to commit to the return visit at the end of the study.

Exclusion Criteria:

1. Clinical Institute Withdrawal Assessment of Alcohol Scale (CIWA-Ar) score \>10 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).
2. Recent history past 6 months) of severe complications due to alcohol withdrawal (alcohol withdrawal seizures, hallucinations/illusions, delirium tremens).
3. Currently or recently (within last 90 days) enrolled in abstinence-based treatment program.
4. Evidence of a maladaptive pattern of substance use or abuse other than alcohol one month prior to screening visit.
5. Uncontrolled severe psychiatric disorder with psychotic symptoms or cognitive impairment. We will not exclude for PTSD.
6. At risk for suicide requiring urgent higher-level care or homicide (based on the Columbia-Suicide Severity Rating Scale and follow-up clinical interview).
7. History of neurological disorder that might be associated with cognitive dysfunction.
8. History of head trauma involving loss of consciousness \>24 hours
9. Clinically significant uncontrolled/unstable medical illness or clinically significant surgery within 1 month of the screening visit.
10. 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, (for females) pregnant or nursing. Any implants will be reviewed for safety.
11. Vagus nerve stimulation related criteria: active implantable medical device, metallic device implanted at or near the neck, carotid atherosclerosis (narrowing of arteries), cervical vagotomy, clinically significant hypertension, hypotension, bradycardia, or tachycardia, cardiac disease and atherosclerotic cardiovascular disease (severe carotid artery disease (e.g., history of transient ischemic attack (TIA) or stroke), congestive heart failure, severe coronary artery disease or recent myocardial infarction (within 5 years)).
12. Pharmacotherapy for AUD: \>= 2 weeks stability is required to ensure a steady state of medication effects prior to nVNS administration.
13. Currently taking opioids or benzodiazepines.
14. In case it is determined by the investigator during the course of the study, that a subject needs a higher level or care, study participation will be discontinued, and the subject will be excluded from the study.

Where this trial is running

San Diego, California

• VA San Diego Healthcare System, San Diego, CA — San Diego, California, United States (RECRUITING)

Study contacts

• Principal investigator: Ruth Klaming, PhD — VA San Diego Healthcare System, San Diego, CA
• Study coordinator: Ruth Klaming, PhD

Conditions: Alcohol Use Disorder, alcohol use disorder, neuromodulation, neuroimaging, withdrawal, anxiety, autonomic nervous system