Actively Recruiting
Use of tAN® in Alcohol Withdrawal Management
Led by Erin Deneke · Updated on 2025-04-20
60
Participants Needed
1
Research Sites
114 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Use of tAN® in Alcohol Withdrawal Management
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ages 18 years old to 65 years old
- Entering an inpatient substance use treatment program for alcohol withdrawal management
- Score 27 or higher on the WHO-ASSIST V3.0
- Proficient in English
- Score 4 or higher on the Prediction of Alcohol Withdrawal Severity Scale (PAWSS)
- Able to provide written informed consent
- Willing to comply with all study procedures and available for the study duration
You will not qualify if you...
- Under 18 or over 65 years old
- Requires medical tapering from benzodiazepines or opioids
- History of epileptic seizures or seizures due to alcohol withdrawal
- Has a cardiac pacemaker, cochlear prosthesis, neurostimulator, or other device contraindicating tAN4
- Abnormal ear anatomy or current ear infection
- Pregnant
- Has any serious medical disease or condition making participation unsafe or compliance difficult
AI-Screening
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Trial Site Locations
Total: 1 location
1
Caron Treatment Centers
Wernersville, Pennsylvania, United States, 19565
Actively Recruiting
Research Team
E
Erin Deneke, Ph.D.
CONTACT
D
Dean Stankoski, M.S.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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