← Back to Clinical Trials
Recruiting NCT06771037

Use of tAN® in Alcohol Withdrawal Management

Trial Parameters

Condition Alcohol Withdrawal
Sponsor Erin Deneke
Study Type INTERVENTIONAL
Phase N/A
Enrollment 60
Sex ALL
Min Age 18 Years
Max Age 65 Years
Start Date 2025-04-21
Completion 2027-03-01
Interventions
Transcutaneous Auricular Neurostimulation (tAN)

Brief 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 Criteria

Inclusion Criteria: 1. Ages 18 years old to 65 years old 2. Entering an inpatient substance use treatment program for alcohol withdrawal management. 3. Score a 27 or higher on the WHO-ASSIST V3.0 4. Is proficient in English 5. Score of a 4 or higher on the Prediction of Alcohol Withdrawal Severity Scale (PAWSS) 6. Able to provide written informed consent. 7. Stated willingness to comply with all study procedures and availability for the duration of the study. Exclusion Criteria: 1. Age \< 18 or \> 65 2. Requires medical tapering from benzodiazepines or opioids. 3. Has a history of epileptic seizures or seizures due to alcohol withdrawal. 4. Has a cardiac pacemaker, cochlear prosthesis, neurostimulator or other device for which tAN® would be contraindicated. 5. Has abnormal ear anatomy or an ear infection is present. 6. Is pregnant. 7. Has any serious medical disease or condition which, in the judgment of the Principal Investigator or his/her designee, would make study participation uns

Related Trials