Use of tAN® in Alcohol Withdrawal Management

NCT06771037 | Recruiting FDA Device

• 1 other identifier: Caron001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcohol Withdrawal

Keywords

Alcohol withdrawal; tAN; transcutaneous auricular neurostimulation

Outcome Measures

Primary Outcomes (2)

• Clinical Institute Withdrawal Assessment Scale, Revised (CIWA-Ar) score

  Linear mixed effects models for repeated measurements will be used to evaluate the difference in changes in these primary outcomes between treatment and sham group. Mixed models take advantage of multiple measures from each individual, allowing for effects both between individuals and within each individual (e.g., across time). The CIWA-Ar is a 10-item scale measuring symptoms of alcohol withdrawal. The scores can range between 0-67. The total score is the sum of all scale items. Scores between 0-9 indicate absent to minimal withdrawal, Scores 10-19 indicate mild to moderate withdrawal and scores greater than 20 indicate severe withdrawal.

  Baseline to end of study day 5

• Amount of comfort medications utilized

  Medications such as ibuprofen, Librium, lorazepam, promethazine, loperamide, and acetaminophen are often used to treat alcohol withdrawal. A t-test will be utilized to compare medication usage between active and sham group.

  Baseline to end of study day 5

Secondary Outcomes (3)

• Change in ambient alcohol craving

  Baseline to end of study day 5

• Change in objective sleep

  Baseline to end of study day 5

• Change in subjective sleep

  Baseline to end of study day 5

Other Outcomes (1)

• Change in mood

  Baseline to end of study day 5

Study Arms (2)

Active Transcutaneous Auricular Neurostimulation (tAN)

EXPERIMENTAL

Transcutaneous auricular stimulation will be delivered using the Sparrow® Link in addition to treatment as usual (TAU). The Sparrow® Link will be set to the following outputs (range 0 mA - 5.0 mA, pulse width 250 µs, frequency 15 Hz at Region 1 (Vagus) and 100 Hz at Region 2 (Trigeminal). Device will be worn for 5 days.

Device: Transcutaneous Auricular Neurostimulation (tAN)

Sham Transcutaneous Auricular Neurostimulation (tAN)

SHAM COMPARATOR

The Sparrow® Link will be set to the sham condition for participants in the sham group and no current will be delivered to either the inner or outer ear, but the screen will appear identical to the active group. Sham group will receive treatment as usual. Sham device will be worn for 5 days.

Device: Transcutaneous Auricular Neurostimulation (tAN)

Interventions

Transcutaneous Auricular Neurostimulation (tAN) DEVICE

Transcutaneous Auricular stimulation will be delivered using the Spark Biomedical Sparrow Link pulse generator with Sparrow Ascent earpieces. The Sparrow Link generator is based on FDA-cleared predicate Sparrow Ascent.

Active Transcutaneous Auricular Neurostimulation (tAN); Sham Transcutaneous Auricular Neurostimulation (tAN)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ages 18 years old to 65 years old
• Entering an inpatient substance use treatment program for alcohol withdrawal management.
• Score a 27 or higher on the WHO-ASSIST V3.0
• Is proficient in English
• Score of a 4 or higher on the Prediction of Alcohol Withdrawal Severity Scale (PAWSS)
• Able to provide written informed consent.
• Stated willingness to comply with all study procedures and availability for the duration of the study.

You may not qualify if:

• Age \< 18 or \> 65
• Requires medical tapering from benzodiazepines or opioids.
• Has a history of epileptic seizures or seizures due to alcohol withdrawal.
• Has a cardiac pacemaker, cochlear prosthesis, neurostimulator or other device for which tAN® would be contraindicated.
• Has abnormal ear anatomy or an ear infection is present.
• Is pregnant.
• 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.

Sponsors & Collaborators

• Erin Deneke: lead

Study Sites (1)

Caron Treatment Centers

Wernersville, Pennsylvania, 19565, United States

RECRUITING

Related Publications (1)

• Tirado CF, Washburn SN, Covalin A, Hedenberg C, Vanderpool H, Benner C, Powell DP, McWade MA, Khodaparast N. Delivering transcutaneous auricular neurostimulation (tAN) to improve symptoms associated with opioid withdrawal: results from a prospective clinical trial. Bioelectron Med. 2022 Aug 18;8(1):12. doi: 10.1186/s42234-022-00095-x.

  PMID: 35978394 BACKGROUND

Study Officials

• Erin Deneke, Ph.D.

  Caron Treatment Centers

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Erin Deneke, Ph.D.

CONTACT

610-743-6242; edeneke@caron.org

Dean Stankoski, M.S.

CONTACT

610-743-6224; dstankoski@caron.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Senior Director of Research

Study Record Dates

• First Submitted: January 2, 2025
• First Posted: January 13, 2025
• Study Start: April 21, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: April 20, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)