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Alcohol WithdrawalNCT06771037

Use of tAN® in Alcohol Withdrawal Management

A study testing Transcutaneous Auricular Neurostimulation (tAN) in people with Alcohol Withdrawal, run by Erin Takemoto at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Alcohol Withdrawal
What is being tested?
Transcutaneous Auricular Neurostimulation (tAN)
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
12 participants
Where
1 siteUnited States
Study dates
21 Apr 2025to 15 Dec 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Caron Treatment Centers

    Wernersville, Pennsylvania, 19565

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Transcutaneous Auricular Neurostimulation (tAN)
Keywords
Alcohol withdrawal, tAN, transcutaneous auricular neurostimulation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT06771037
Study groupRoleWhat they receive
Active Transcutaneous Auricular Neurostimulation (tAN)ExperimentalTranscutaneous 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.
Receives: Device: Transcutaneous Auricular Neurostimulation (tAN)
Sham Transcutaneous Auricular Neurostimulation (tAN)Sham comparatorThe 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.
Receives: Device: Transcutaneous Auricular Neurostimulation (tAN)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline to end of study day 5

  2. 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.

    Measured: Baseline to end of study day 5

Secondary outcomes (3)

  1. 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

    Measured: Baseline to end of study day 5

  2. 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).

    Measured: Baseline to end of study day 5

  3. 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.

    Measured: Baseline to end of study day 5

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jan 2025
  2. Study start21 Apr 2025
  3. Primary completion7 Oct 2025
  4. Study completion15 Dec 2025

Why it stopped: Primary investigator left the organization for another job

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06771037
Sponsor's protocol ID
Caron001
Status last verified
Aug 2026
First submitted
2 Jan 2025
Last updated
5 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

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.

    PubMed 35978394

Questions about this trial

What is this clinical trial studying?

A study testing Transcutaneous Auricular Neurostimulation (tAN) in people with Alcohol Withdrawal, run by Erin Takemoto at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Primary investigator left the organization for another job). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical Institute Withdrawal Assessment Scale, Revised (CIWA-Ar) score (time frame: Baseline to end of study day 5). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06771037, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.

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