Study of tAN® for Alcohol Withdrawal
This study is looking at whether a device called Transcutaneous Auricular Neurostimulation (tAN®) can help people manage alcohol withdrawal symptoms. tAN® works by sending small electrical signals to certain nerves. Researchers want to see if this device can reduce withdrawal symptoms and the need for comfort medications. You could be eligible if you are 18-65 years old, entering an inpatient program for alcohol withdrawal, and meet other specific criteria. The study will measure your withdrawal symptoms using a scale called CIWA-Ar and track how much comfort medication you use over five days. The study is currently unclear on its recruitment status and plans to enroll 60 participants.
- Study design
- This is an interventional study with 60 participants. You would be randomly assigned to either receive the tAN® device plus usual care, or usual care alone (sham group).
- What's involved
- You would participate for five days, with data collected four times a day. This includes assessments of alcohol craving, mood, sleep, and physical activity, along with daily withdrawal symptom checks.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary measurements for this study are taken from baseline to the end of study day 5.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Use of tAN® in Alcohol Withdrawal Management
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Erin Deneke, Ph.D. · PRINCIPAL_INVESTIGATOR · Caron Treatment Centers
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
What this trial measures
- Clinical Institute Withdrawal Assessment Scale, Revised (CIWA-Ar) scoreBaseline to end of study day 5
Linear mixed effects models for repeated measurements will be used to evaluate the difference in changes in these primary outcomes between treatment and sham group. Mixed models take advantage of multiple measures from each individual, allowing for effects both between individuals and within each individual (e.g., across time). The CIWA-Ar is a 10-item scale measuring symptoms of alcohol withdrawal. The scores can range between 0-67. The total score is the sum of all scale items. Scores between 0-9 indicate absent to minimal withdrawal, Scores 10-19 indicate mild to moderate withdrawal and scores greater than 20 indicate severe withdrawal.
- Amount of comfort medications utilizedBaseline to end of study day 5
Medications such as ibuprofen, Librium, lorazepam, promethazine, loperamide, and acetaminophen are often used to treat alcohol withdrawal. A t-test will be utilized to compare medication usage between active and sham group.