Use of tAN® in Alcohol Withdrawal Management
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 conducte
| Condition(s) | Alcohol Withdrawal |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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 | 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 a |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Lead sponsor | Erin Deneke |
| Locations | Wernersville, Pennsylvania, United States |
| Start date | 2025-04-21 |
| NCT ID | NCT06771037 |
| Official listing | https://clinicaltrials.gov/study/NCT06771037 |