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Ear stimulation device may tame alcohol withdrawal symptoms

NCT ID NCT06771037

Symptom relief Sponsor: Erin Takemoto Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 05, 2026 · Last updated Aug 06, 2026 · Updated 1 time

Summary

This study tests whether a wearable device that sends tiny electrical pulses to the ear — a method called transcutaneous auricular neurostimulation (tAN) — can help people going through alcohol withdrawal. The device targets the vagus and trigeminal nerves, which may influence withdrawal symptoms like cravings, anxiety, and sleep problems. Over five days, participants entering inpatient treatment for alcohol withdrawal will be randomly assigned to receive either the active device or a sham (inactive) device, alongside standard care. Researchers will track withdrawal severity, use of comfort medications, cravings, sleep, and mood to see if the device makes a difference.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Transcutaneous Auricular Neurostimulation (tAN) — a wearable device that delivers small electrical pulses to the ear to stimulate the vagus and trigeminal nerves.
What this could lead to
If effective, this non-invasive device could offer a drug-free way to ease alcohol withdrawal symptoms, reducing the need for comfort medications and improving the detox experience.
What could go wrong
This is a small early-stage trial, so results may not be conclusive. The device may not outperform a sham (placebo) device, and individual responses can vary.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

12 people

The number who actually took part.

Started

Apr 2025

Finished

Dec 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

alcohol withdrawal

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Alcohol withdrawal

Contacts and locations

Locations

  • Caron Treatment Centers

    Wernersville, Pennsylvania, 19565, United States

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