Use of tAN® in Alcohol Withdrawal Management

Description

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

Alcohol Withdrawal

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Study Overview

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Study Details

Study overview

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.

The Use of Non-invasive Transcutaneous Auricular Neurostimulation (tAN®) in Alcohol Withdrawal Management

Use of tAN® in Alcohol Withdrawal Management

Condition
Alcohol Withdrawal
Intervention / Treatment

-

Contacts and Locations

Wernersville

Caron Treatment Centers, Wernersville, Pennsylvania, United States, 19565

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 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.

Ages Eligible for Study

18 Years to 65 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Erin Deneke,

Erin Deneke, Ph.D., PRINCIPAL_INVESTIGATOR, Caron Treatment Centers

Study Record Dates

2027-07-01