RECRUITING

Use of tAN® in Alcohol Withdrawal Management

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2025-04-21
Study Completion:2027-07-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06771037

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.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Ages 18 years old to 65 years old
  2. 2. Entering an inpatient substance use treatment program for alcohol withdrawal management.
  3. 3. Score a 27 or higher on the WHO-ASSIST V3.0
  4. 4. Is proficient in English
  5. 5. Score of a 4 or higher on the Prediction of Alcohol Withdrawal Severity Scale (PAWSS)
  6. 6. Able to provide written informed consent.
  7. 7. Stated willingness to comply with all study procedures and availability for the duration of the study.
  1. 1. Age \< 18 or \> 65
  2. 2. Requires medical tapering from benzodiazepines or opioids.
  3. 3. Has a history of epileptic seizures or seizures due to alcohol withdrawal.
  4. 4. Has a cardiac pacemaker, cochlear prosthesis, neurostimulator or other device for which tAN® would be contraindicated.
  5. 5. Has abnormal ear anatomy or an ear infection is present.
  6. 6. Is pregnant.
  7. 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.

Contacts and Locations

Study Contact

Erin Deneke, Ph.D.
CONTACT
610-743-6242
edeneke@caron.org
Dean Stankoski, M.S.
CONTACT
610-743-6224
dstankoski@caron.org

Principal Investigator

Erin Deneke, Ph.D.
PRINCIPAL_INVESTIGATOR
Caron Treatment Centers

Study Locations (Sites)

Caron Treatment Centers
Wernersville, Pennsylvania, 19565
United States

Collaborators and Investigators

Sponsor: Erin Deneke

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-21
Study Completion Date2027-07-01

Study Record Updates

Study Start Date2025-04-21
Study Completion Date2027-07-01

Terms related to this study

Keywords Provided by Researchers

  • Alcohol withdrawal
  • tAN
  • transcutaneous auricular neurostimulation

Additional Relevant MeSH Terms

  • Alcohol Withdrawal