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Using Transcutaneous Auricular Vagus Nerve Stimulation to Treat Acute Alcohol Withdrawal

NCT04159909 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2024-03-13

No results posted yet for this study

Summary

The purpose of this study is to see if stimulation of the vagus nerve via a non-invasive device placed behind external ear can reduce physical and psychological discomfort during acute alcohol withdrawal in patients with alcohol use disorder when people just stop drinking alcohol and in detoxification stage.

Conditions

Interventions

DEVICE

Transcutaneous Nerve Stimulation

510(K) number: K110390 vagus nerve for 5 minutes twice a day for 4 consecutive days

DEVICE

Sham Stimulation

sham stimulation (no electrical current) for 5 minutes twice a day for 4 consecutive days

Sponsors & Collaborators

  • Northwell Health

    lead OTHER

Principal Investigators

  • Andrew C Chen, MD, PhD · Northwell Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-31
Primary Completion
2024-09-30
Completion
2025-01-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04159909 on ClinicalTrials.gov