RecruitingNot ApplicableNCT06771037

Use of tAN® in Alcohol Withdrawal Management

The Use of Non-invasive Transcutaneous Auricular Neurostimulation (tAN®) in Alcohol Withdrawal Management

Sponsor

Erin Deneke

Enrollment

60 participants

Start Date

Apr 21, 2025

Study Type

INTERVENTIONAL

Conditions

alcohol withdrawal

Summary

This research study is being conducted to learn if Transcutaneous Auricular Neurostimulation (tAN®) may be effective in treating alcohol withdrawal syndrome. Transcutaneous Auricular Neurostimulation (tAN®) works by delivering small electrical stimulations to the Vagus and Trigeminal nerves. This study will be conducted over the course of five days. Participants will be enrolled within 24 hours of entering treatment for alcohol withdrawal management. A total of 60 individuals will be enrolled and randomly assigned to either active (treatment with the device + treatment as usual) or sham (treatment as usual) group. Data will be collected on alcohol craving, use of comfort medications, sleep, and mood.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria7

Ages 18 years old to 65 years old
Entering an inpatient substance use treatment program for alcohol withdrawal management.
Score a 27 or higher on the WHO-ASSIST V3.0
Is proficient in English
Score of a 4 or higher on the Prediction of Alcohol Withdrawal Severity Scale (PAWSS)
Able to provide written informed consent.
Stated willingness to comply with all study procedures and availability for the duration of the study.

Exclusion Criteria7

Age < 18 or > 65
Requires medical tapering from benzodiazepines or opioids.
Has a history of epileptic seizures or seizures due to alcohol withdrawal.
Has a cardiac pacemaker, cochlear prosthesis, neurostimulator or other device for which tAN® would be contraindicated.
Has abnormal ear anatomy or an ear infection is present.
Is pregnant.
Has any serious medical disease or condition which, in the judgment of the Principal Investigator or his/her designee, would make study participation unsafe, or would make intervention compliance difficult.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICETranscutaneous Auricular Neurostimulation (tAN)

Transcutaneous Auricular stimulation will be delivered using the Spark Biomedical Sparrow Link pulse generator with Sparrow Ascent earpieces. The Sparrow Link generator is based on FDA-cleared predicate Sparrow Ascent.