NCT06771037 Use of tAN® in Alcohol Withdrawal Management
| NCT ID | NCT06771037 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Erin Deneke |
| Condition | Alcohol Withdrawal |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-04-21 |
| Primary Completion | 2027-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2025-04-21 with a primary completion date of 2027-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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.
Contact & Investigator
Erin Deneke, Ph.D.
PRINCIPAL INVESTIGATOR
Caron Treatment Centers
Frequently Asked Questions
Who can join the NCT06771037 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Alcohol Withdrawal. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06771037 currently recruiting?
Yes, NCT06771037 is actively recruiting participants. Contact the research team at edeneke@caron.org for enrollment information.
Where is the NCT06771037 trial being conducted?
This trial is being conducted at Wernersville, United States.
Who is sponsoring the NCT06771037 clinical trial?
NCT06771037 is sponsored by Erin Deneke. The principal investigator is Erin Deneke, Ph.D. at Caron Treatment Centers. The trial plans to enroll 60 participants.