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Device

Vagal Nerve Stimulation for Alcoholism

N/A
Waitlist Available
Led By Ruth Klaming, PhD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Must not have
Currently taking opioids or benzodiazepines
Clinically significant uncontrolled/unstable medical illness or clinically significant surgery within 1 month of the screening visit
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to week 1 and 1 month post baseline of 2x daily intervention
Awards & highlights

Summary

This trial aims to study a new treatment approach for alcohol use disorder (AUD) in Veterans. The researchers believe that targeting the vagus nerve, a nerve that connects the brain and body, could be

Who is the study for?
This trial is for veterans with Alcohol Use Disorder (AUD) who are seeking new treatments to improve their quality of life and reduce the urge to drink. Specific eligibility criteria details were not provided, so interested individuals should contact the study organizers for more information.
What is being tested?
The trial is testing a non-invasive treatment called cervical transcutaneous vagus nerve stimulation. Participants will be randomly assigned to receive either the active treatment or a sham (placebo) version to compare outcomes in managing AUD symptoms.
What are the potential side effects?
Since this is a non-invasive procedure, side effects may be minimal but could include mild discomfort at the site of stimulation or headache. The exact side effects are not detailed here and would need clarification from the study team.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am currently taking opioids or benzodiazepines.
Select...
I haven't had major surgery or uncontrolled illness in the last month.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to week 1 and 1 month post baseline of 2x daily intervention
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 1 and 1 month post baseline of 2x daily intervention for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Alcohol Urge Questionnaire (AUQ)
Clinical Institute Withdrawal Assessment of Alcohol Scale, Revised (CIWA-Ar)
Hamilton Anxiety Rating Scale (HAM-A)
+1 more
Secondary study objectives
Neural response to heat pain fMRI task
Other study objectives
Physiological response to heat pain fMRI task
Substance Use Recovery Evaluator (SURE)
The Drinker Inventory of Consequences (DrInC)

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Active cervical transcutaneous vagus nerve stimulationActive Control1 Intervention
Participants will be assigned to active transcutaneous vagus nerve stimulation, received once during each of the study visits and self-administered twice a day for a week.
Group II: Sham cervical transcutaneous vagus nerve stimulationPlacebo Group1 Intervention
Participants will be assigned to sham transcutaneous vagus nerve stimulation, received once during each of the study visits and self-administered twice a day for a week.

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Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,647 Previous Clinical Trials
3,359,990 Total Patients Enrolled
43 Trials studying Alcoholism
6,014 Patients Enrolled for Alcoholism
Ruth Klaming, PhDPrincipal InvestigatorVA San Diego Healthcare System, San Diego, CA
1 Previous Clinical Trials
19 Total Patients Enrolled
1 Trials studying Alcoholism
19 Patients Enrolled for Alcoholism
~53 spots leftby Aug 2028
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