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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

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:

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I am currently taking opioids or benzodiazepines.

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I haven't had major surgery or uncontrolled illness in the last month.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to week 1 and 1 month post baseline of 2x daily intervention

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.

0 / 2Eligibility criteria met