← Back to Search

Behavioural Intervention

Vagus Nerve Stimulation for Alcoholism

Phase 1
Recruiting
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)
Awards & highlights

Study Summary

This trial is testing whether stimulating the vagus nerve can help people with alcohol use disorder by reducing cravings and improving quality of life. The study will also look at whether this treatment alters brain activity related to perception and awareness of distress and pain.

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.Check my eligibility
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.See study design
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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Measurement of feasibility - Adverse side effects
Measurement of feasibility - Recruitment goal
Measurement of feasibility - Subject retention
+2 more
Secondary outcome measures
Alcohol Urge Questionnaire (AUQ)
Beck Anxiety Inventory (BAI)
PROMIS Pain Interference
+2 more
Other outcome measures
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.

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,606 Previous Clinical Trials
3,305,985 Total Patients Enrolled
41 Trials studying Alcoholism
6,455 Patients Enrolled for Alcoholism
Ruth Klaming, PhDPrincipal InvestigatorVA San Diego Healthcare System, San Diego, CA

Media Library

Cervical transcutaneous vagus nerve stimulation (active comparator) (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05226130 — Phase 1
Alcoholism Research Study Groups: Active cervical transcutaneous vagus nerve stimulation, Sham cervical transcutaneous vagus nerve stimulation
Alcoholism Clinical Trial 2023: Cervical transcutaneous vagus nerve stimulation (active comparator) Highlights & Side Effects. Trial Name: NCT05226130 — Phase 1
Cervical transcutaneous vagus nerve stimulation (active comparator) (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05226130 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How conducive is Active cervical transcutaneous vagus nerve stimulation to patient well-being?

"With limited evidence for safety and efficacy, Active cervical transcutaneous vagus nerve stimulation received a low score of 1."

Answered by AI

Is eligibility open to participate in this experiment?

"This medical experiment is enrolling 16 adults who suffer from alcoholism. These participants must have attained the age of majority, be male, and between 21 to 65 years old. Moreover, they need to meet criteria for a DSM-5 diagnosis of AUD with an associated life impairment due to alcohol consumption; as well as present cravings and regular binging behaviour (>4 units on any day or >14 drinks per week)."

Answered by AI

What are the anticipated results of this clinical investigation?

"During this clinical trial, the primary outcome measure to assess efficacy and treatment adherence will be observed over a baseline period extending from week 1 of 2x daily intervention. Secondary evaluation variables include Substance Use Recovery Evaluator (SURE), WHO Quality of Life assessment (WHOQOL-BREF) and PROMIS Pain Interference. These metrics range in scale from 3 point scales up to 5 point scales with score interpretations varying between items."

Answered by AI

Are there any openings remaining to participate in this trial?

"Affirmative. Clinicaltrials.gov data indicates that this study, which was initially announced on April 1st 2022, is actively recruiting volunteers. Approximately 16 participants must be sourced from one medical centre for the trial to progress."

Answered by AI

Does this research encompass persons of advanced age?

"This clinical trial's admission criteria necessitates that potential participants be between 21 and 65 years old. Simultaneously, 33 studies are available for underage persons and 249 for the elderly."

Answered by AI

How many participants are being enrolled in this clinical research?

"Confirmed. According to clinicaltrials.gov, this medical experiment was first made public on April 1st 2022 and is still actively recruiting participants at a single site. A total of 16 individuals need to be enrolled in the study."

Answered by AI

Who else is applying?

What state do they live in?
California
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What site did they apply to?
VA San Diego Healthcare System, San Diego, CA
~1 spots leftby May 2024