WithdrawnNot Applicable

Using Transcutaneous Auricular Vagus Nerve Stimulation to Treat Acute Alcohol Withdrawal

Stopped: Study site, detoxification unit at South Oaks Hospital, was closed/partially open. Northwell addiction has been unable to provide any projected/workable plan(s).

United States0Started 2024-01-31

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexALL

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Inclusion criteria

✓. age 18-65 years (men and women);
✓. primary current diagnosis of DSM-V Alcohol Use Disorder as indicated at admission;
✓. being admitted to inpatient detoxification unit;
✓. no evidence of significant cognitive impairment with a mini mental state examination (MMSE; Folstein et al., 1975) score \> 22;
✓. able and willing to give written informed consent and comply with the requirements of the study protocol.

Exclusion criteria

✕. current DSM-V substance use disorders (other than tobacco / cannabis/ alcohol);
✕. serious psychiatric illnesses, e.g. psychotic disorders or bipolar disorder
✕. severe medical illnesses, present or history of, e.g. hepatic encephalopathy, delirium
✕. history of significant medical problems associated with drinking including seizures;
✕. pregnancy;
✕. severe intellectual/cognitive deficits due to Korsakoff's syndrome, dementia, head injury, or others
✕. treatment with an anti-cholinergic medication, including over the counter medications,
✕. implantable electronic devices such as pacemakers, defibrillators, hearing aids, cochlear implants or deep brain stimulators.

What they're measuring

The primary clinical outcome is the reduction of the alcohol withdrawal symptoms assessed by the Clinical Institute Withdrawal Assessment for Alcohol-Revised (CIWA-Ar)

Timeframe: 3 months after completion of pilot study (enrollment)

Trial details

NCT IDNCT04159909

SponsorNorthwell Health

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-09-30

View on ClinicalTrials.gov More Alcohol Withdrawal trials