Use of tAN® in Alcohol Withdrawal Management

Launched by ERIN DENEKE · Jan 7, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called Transcutaneous Auricular Neurostimulation (tAN®) to see if it can help people manage alcohol withdrawal symptoms. The trial will last for five days and involves 60 participants who are starting treatment for alcohol withdrawal. Participants will be randomly assigned to either receive the tAN® treatment along with standard care or just the standard care alone. Researchers will gather information on things like how much participants crave alcohol, how well they sleep, and their mood during this time.

To be eligible for this study, participants need to be between 18 and 65 years old and entering a treatment program for alcohol withdrawal. They should also be able to speak English and provide consent to join the study. However, there are some people who cannot participate, such as those with a history of seizures, certain medical devices, or serious health issues. If you think you might qualify and are interested in helping researchers learn more about this potential treatment, please consider discussing it with your healthcare provider.

Gender

ALL

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 unsafe, or would make intervention compliance difficult.