What side effects are associated with this type of intervention?

Common treatments for alcoholism, such as naltrexone, can cause side effects including nausea, headache, dizziness, fatigue, and in some cases, liver toxicity. Noninvasive vagal nerve stimulation (nVNS), which is being studied for its potential to reduce the urge to drink by modifying the perception of distressing bodily sensations, has shown mild side effects such as a warm sensation, redness, itching, tingling, and muscle spasms. These treatments aim to reduce alcohol craving and consumption, but patients should discuss potential side effects with their healthcare provider.

What prior FDA approvals exist?

FDA-approved treatments for alcoholism primarily include medications such as disulfiram, naltrexone, and acamprosate. Disulfiram works by causing unpleasant effects when alcohol is consumed, while naltrexone reduces the rewarding effects of alcohol and cravings. Acamprosate helps to stabilize the chemical balance in the brain that is disrupted by alcohol dependence. While these medications do not share the same mechanism as noninvasive vagal nerve stimulation (nVNS), which modifies the perception of distressing bodily sensations to reduce the urge to drink, they are the main pharmacologic options currently approved by the FDA for treating alcoholism.

What other types of research exist?

Promising novel alternatives to nVNS for treating alcoholism include: 1) Transcranial Magnetic Stimulation (TMS), which has shown efficacy in mood disorders and may help reduce cravings; 2) Deep Brain Stimulation (DBS), which has been effective in other compulsive disorders and could potentially reduce alcohol cravings; 3) Pharmacologic agents like Naltrexone and Acamprosate, which help reduce cravings and withdrawal symptoms; 4) Behavioral interventions such as Cognitive Behavioral Therapy (CBT) and Mindfulness-Based Relapse Prevention (MBRP), which address the psychological aspects of addiction.

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Behavioural Intervention

Vagus Nerve Stimulation for Alcoholism

Phase 1

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

Male subjects between 21 and 65 years of age

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to week 1 of 2x daily intervention (measure only administered at at study completion, i.e., 1 week after baseline)

Summary

This trial is testing a new treatment called noninvasive vagal nerve stimulation (nVNS) for Veterans with Alcohol Use Disorder. The treatment aims to reduce anxiety and cravings by sending gentle electrical signals to a nerve in the neck. Researchers hope this will help Veterans who struggle with current treatments and improve their quality of life. Noninvasive vagus nerve stimulation (nVNS) is a recently released therapy that has been explored for conditions like cluster headaches and epilepsy.

Who is the study for?

This trial is for male Veterans aged 21-65 with Alcohol Use Disorder (AUD) who drink heavily and have at least one disability due to alcohol use. They must be able to stop drinking for a day without severe withdrawal symptoms. Excluded are those with neurological issues, recent abstinence treatment, unstable medical conditions, certain MRI contraindications, or severe mental illness.

What is being tested?

The study tests non-invasive vagal nerve stimulation (nVNS) as a potential treatment for AUD in Veterans. It compares active nVNS against sham (fake) nVNS to see if it can reduce distress and the urge to drink by affecting brain regions related to distress perception.

What are the potential side effects?

Potential side effects of nVNS may include mild discomfort at the stimulation site on the neck, headache, voice changes or hoarseness, tingling sensation in the skin, and possibly temporary changes in heart rate or blood pressure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am a man aged between 21 and 65.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to week 1 of 2x daily intervention (measure only administered at at study completion, i.e., 1 week after baseline)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to week 1 of 2x daily intervention (measure only administered at at study completion, i.e., 1 week after baseline)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 1 of 2x daily intervention (measure only administered at at study completion, i.e., 1 week after baseline) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Measurement of feasibility - Adverse side effects

Measurement of feasibility - Recruitment goal

Measurement of feasibility - Subject retention

+2 more

Secondary study objectives

Alcohol Urge Questionnaire (AUQ)

Beck Anxiety Inventory (BAI)

PROMIS Pain Interference

+2 more

Other study objectives

Heat pain fMRI task

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 / 1Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for alcoholism often target the neurological and psychological aspects of addiction. Noninvasive vagal nerve stimulation (nVNS) works by modifying the perception of distressing bodily sensations, which can reduce the urge to drink by alleviating anxiety and discomfort associated with withdrawal. Similarly, activation of brain NOP receptors and administration of neuropeptide S (NPS) in the basolateral amygdala have shown promise in reducing withdrawal symptoms and alcohol consumption by modulating neuronal activity and promoting anxiolysis. These treatments are crucial for alcoholism patients as they address the underlying distress and cravings that drive the compulsion to drink, thereby supporting long-term recovery and improving quality of life.

Chronic ethanol potentiates the effect of neuropeptide s in the basolateral amygdala and shows increased anxiolytic and anti-depressive effects.Activation of brain NOP receptors attenuates acute and protracted alcohol withdrawal symptoms in the rat.