Use of tAN® in Alcohol Withdrawal Management (NCT06771037) | Clinical Trial Compass
RecruitingNot Applicable
Use of tAN® in Alcohol Withdrawal Management
United States60 participantsStarted 2025-04-21
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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 criteria
✕. Age \< 18 or \> 65
✕. Requires medical tapering from benzodiazepines or opioids.
✕. Has a history of epileptic seizures or seizures due to alcohol withdrawal.
✕
What they're measuring
1
Clinical Institute Withdrawal Assessment Scale, Revised (CIWA-Ar) score
. 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.