Using tAN® to manage alcohol withdrawal symptoms
The Use of Non-invasive Transcutaneous Auricular Neurostimulation (tAN®) in Alcohol Withdrawal Management
This study is testing if a new treatment called Transcutaneous Auricular Neurostimulation (tAN®) can help people going through alcohol withdrawal feel better and need less medication.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Caron Treatment Centers Academic / other |
| Locations | 1 site (Wernersville, Pennsylvania) |
| Trial ID | NCT06771037 on ClinicalTrials.gov |
What this trial studies
This research investigates the effectiveness of Transcutaneous Auricular Neurostimulation (tAN®) in alleviating symptoms of alcohol withdrawal syndrome. The study will enroll 60 participants who will be randomly assigned to receive either active tAN® treatment combined with standard care or a sham treatment with standard care. Over five days, data will be collected on various factors including alcohol cravings, mood, and sleep patterns using ecological momentary assessment and fitness trackers. The goal is to determine if tAN® can reduce withdrawal symptoms and the need for comfort medications.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 65 who are entering inpatient treatment for alcohol withdrawal and meet specific clinical criteria.
Not a fit: Patients requiring tapering from benzodiazepines or opioids, or those with certain medical conditions, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a non-invasive method to ease alcohol withdrawal symptoms and improve patient comfort during treatment.
How similar studies have performed: Previous studies have shown tAN® to be effective in reducing symptoms of opioid withdrawal, suggesting potential for success in alcohol withdrawal management.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Wernersville, Pennsylvania
- Caron Treatment Centers — Wernersville, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Erin Deneke, Ph.D. — Caron Treatment Centers
- Study coordinator: Erin Deneke, Ph.D.
- Email: edeneke@caron.org
- Phone: 610-743-6242
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.