Use of tAN® in Alcohol Withdrawal Management

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

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.

Study Overview

• Status: Recruiting
• Conditions: Alcohol Withdrawal
• Intervention / Treatment: Device: Transcutaneous Auricular Neurostimulation (tAN)

Detailed Description

This study will explore whether the use of a non-invasive Transcutaneous Auricular Neurostimulation (tAN®) device, Sparrow® Link, can be used to relieve symptoms of alcohol withdrawal symptoms and reduce the need for comfort medications during alcohol withdrawal management. This study will recruit 60 participants randomized to either active tAN® + Treatment as Usual (TAU) or sham tAN® + TAU, 30 participants in each arm. Data will be collected four times a day for 5 days, exploring ambient alcohol craving, mood, and sleep using Ecological Momentary Assessment (EMA; Wear-IT framework). Data for stress response, sleep and physical activity will also be collected using a fitness activity tracker (Garmin Vivosmart 4). In addition, the Clinical Institute Withdrawal Assessment, Revised (CIWA-AR) will be administered daily as well. Transcutaneous Auricular Neurostimulation has proven effective in reducing symptoms of opioid withdrawal and it is hypothesized that with the similar withdrawal symptom profile of alcohol withdrawal should prove effective in reducing symptoms of alcohol withdrawal as well.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Erin Deneke, Ph.D.; Phone Number: 610-743-6242; Email: edeneke@caron.org
• Study Contact Backup: Name: Dean Stankoski, M.S.; Phone Number: 610-743-6224; Email: dstankoski@caron.org

Study Locations

• United States
  • Pennsylvania
    • Wernersville, Pennsylvania, United States, 19565
      • Recruiting
      • Caron Treatment Centers
      • Contact: Erin Deneke, Ph.D.; Phone Number: 610-743-6242; Email: edeneke@caron.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active Transcutaneous Auricular Neurostimulation (tAN); 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); 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.
Sham Comparator: Sham Transcutaneous Auricular Neurostimulation (tAN); 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); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in ambient alcohol craving	Change in ambient alcohol craving will be measured using a 0-100 Visual Analog Scale (VAS) delivered by smartphone using Ecological Momentary Assessment (EMA) delivered 4 times per day. EMA will be analyzed as a mixed model in the regression framework and will test effects of treatment status as between-group differences	Baseline to end of study day 5
Change in objective sleep	Objective sleep will be measured using wrist actigraphy. Analyses of actigraphy data will examine the effect of time (i.e., study day) to identify differences across condition in the amount of sleep (i.e. minutes).	Baseline to end of study day 5
Change in subjective sleep	Subjective sleep will be measured using EMA. Analyses of EMA data will examine the effect of time (i.e., study day) to identify differences across condition in the quality of sleep.	Baseline to end of study day 5

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in mood	The impact of the Sparrow® Link treatment on mood will be primarily measured using EMA assessment and will be modeled using linear mixed models in the multilevel modeling (MLM) framework.	Baseline to end of study day 5

Collaborators and Investigators

• Sponsor: Erin Deneke
• Investigators: Principal Investigator: Erin Deneke, Ph.D., Caron Treatment Centers

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): April 21, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: January 2, 2025
• First Submitted That Met QC Criteria: January 7, 2025
• First Posted (Actual): January 13, 2025

Study Record Updates

• Last Update Posted (Actual): April 20, 2025
• Last Update Submitted That Met QC Criteria: April 16, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Alcohol withdrawal; transcutaneous auricular neurostimulation; tAN
• Other Study ID Numbers: Caron001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes