Transcutaneous Auricular Neurostimulation for Alcohol Withdrawal

Overseen By Dean Stankoski, M.S.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Erin Deneke

Must not be taking: Benzodiazepines, Opioids

Disqualifiers: Epileptic seizures, Pacemaker, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 5 days

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a device called Transcutaneous Auricular Neurostimulation (tAN®) can help treat alcohol withdrawal syndrome. The device delivers small electrical stimulations to nerves in the ear, potentially reducing symptoms like cravings and mood changes. Participants will receive either the active treatment with the device or a sham (fake) treatment, along with the usual care for alcohol withdrawal. This trial suits individuals entering inpatient alcohol treatment with moderate to severe alcohol dependence. As an unphased trial, it offers a unique opportunity to explore innovative treatment options for alcohol withdrawal syndrome.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you require medical tapering from benzodiazepines or opioids, you cannot participate in the study.

What prior data suggests that Transcutaneous Auricular Neurostimulation is safe for treating alcohol withdrawal?

Research has shown that Transcutaneous Auricular Neurostimulation (tAN) is safe and generally well-tolerated. One study found that tAN quickly relieved symptoms with lasting effects and no serious side effects. Another study discovered it improved mood and sleep in individuals who had stopped drinking alcohol. Overall, this treatment has been used safely in various situations and appears to be well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Transcutaneous Auricular Neurostimulation (tAN) for alcohol withdrawal because it offers a non-invasive treatment option that directly stimulates nerves in the ear. Unlike traditional treatments that often involve medications like benzodiazepines or anticonvulsants, tAN uses electrical pulses to target the vagus and trigeminal nerves, potentially reducing withdrawal symptoms without the need for drugs. This approach may offer a safer alternative with fewer side effects and the potential for rapid relief, providing new hope for individuals undergoing alcohol withdrawal.

What evidence suggests that Transcutaneous Auricular Neurostimulation (tAN) is effective for alcohol withdrawal?

Research has shown that transcutaneous auricular neurostimulation (tAN) might alleviate symptoms of alcohol withdrawal. In this trial, participants will join either an active tAN group or a sham tAN group. Similar treatments have reduced withdrawal symptoms for other drugs, such as opioids. One study found that this nerve stimulation improved sleep and mood in individuals with alcohol dependence. These findings suggest that tAN might reduce cravings and make withdrawal more comfortable. By stimulating certain nerves, tAN could offer a non-invasive method to ease withdrawal symptoms. ^{2 6 7 8 9}

Who Is on the Research Team?

Erin Deneke, Ph.D.

Principal Investigator

Caron Treatment Centers

Are You a Good Fit for This Trial?

This trial is for individuals aged 18-65 entering inpatient treatment for alcohol withdrawal who score high on specific scales measuring alcohol issues and can consent to the study. It excludes those needing medical tapering from certain drugs, with a history of seizures, abnormal ear anatomy or infections, pregnant women, and anyone with conditions making participation unsafe.

Inclusion Criteria

I am entering a program for alcohol withdrawal.

Scoring a 27 or higher on the WHO-ASSIST V3.0

Proficient in English

Exclusion Criteria

I need help to gradually stop taking benzodiazepines or opioids.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 day

1 visit (in-person)

Treatment

Participants receive either active or sham Transcutaneous Auricular Neurostimulation (tAN®) for alcohol withdrawal management

5 days

Daily monitoring (4 times per day)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Transcutaneous Auricular Neurostimulation (tAN)

Trial Overview The study tests if Transcutaneous Auricular Neurostimulation (tAN®), which stimulates nerves in the ear using electrical pulses, helps treat alcohol withdrawal symptoms over five days. Participants are randomly placed into two groups: one receiving tAN® plus usual treatment and another receiving only usual treatment.

How Is the Trial Designed?

Group I: Active Transcutaneous Auricular Neurostimulation (tAN) Experimental Treatment 1 Intervention

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.

Group II: Sham Transcutaneous Auricular Neurostimulation (tAN) Placebo Group 1 Intervention

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.

Who Is Running the Clinical Trial?

Erin Deneke

Lead Sponsor

Trials

1

Recruited

60+

Published Research Related to This Trial

Auricular acupuncture for smoking cessation was found to be effective, with an odds ratio of 2.24 indicating a significant improvement compared to control interventions in 10 studies, including those of high validity.

However, the effectiveness did not significantly differ between 'correct' and 'incorrect' acupuncture points, suggesting that the location of the points may not be as important as previously thought, challenging the traditional somatotopic model of auricular acupuncture.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of auricular acupuncture on smoking cessation may not depend on the point chosen--an exploratory meta-analysis. White, A., Moody, R.[2019]

Auricular transcutaneous vagus nerve stimulation (atVNS) may serve as an effective add-on treatment for alcohol use disorder (AUD) by directly stimulating brain areas that regulate neurotransmitters affected by alcohol, potentially improving cognitive control and aiding in maintaining abstinence.

AtVNS can be easily integrated into daily life as it is a noninvasive technique that can be worn like an earpiece, making it a convenient option for patients who struggle with traditional treatment methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Auricular transcutaneous vagus nerve stimulation for alcohol use disorder: A chance to improve treatment? Konjusha, A., Colzato, L., Ghin, F., et al.[2022]

Transcutaneous auricular neurostimulation (tAN) significantly reduced opioid withdrawal symptoms, with a mean decrease of 7.0 points on the Clinical Opiate Withdrawal Scale (COWS) after 60 minutes of treatment, indicating a 45.9% reduction in symptoms.

The study demonstrated that tAN is a safe and effective non-opioid treatment for managing opioid withdrawal syndrome, achieving up to a 74.7% reduction in COWS scores over a 5-day period, supporting its FDA clearance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Delivering transcutaneous auricular neurostimulation (tAN) to improve symptoms associated with opioid withdrawal: results from a prospective clinical trial. Tirado, CF., Washburn, SN., Covalin, A., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06771037

Use of 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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9385243/

Delivering transcutaneous auricular neurostimulation (tAN) to ... The primary endpoint was change in COWS score from baseline to 60-minutes after start of active tAN therapy, pooled across all participants. A ...

3. frontiersin.org frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2021.678594/full

Effect of Transcutaneous Auricular Vagus Nerve ... The present study is the first to demonstrate that taVNS could improve depression and sleep quality in patients with alcohol dependence after withdrawal.

4. menningerclinic.org menningerclinic.org/blog/new-nih-funded-study-aims-to-advance-treatment-for-alcohol-use-disorder

New NIH-Funded Study Aims to Advance Treatment for ... Previous studies show that activating auricular cranial nerve branches via tAN offers a similar reduction in substance withdrawal symptoms (particularly opioid) ...

5. globenewswire.com globenewswire.com/news-release/2025/10/20/3169550/0/en/Spark-Biomedical-Awarded-an-NIH-Grant-to-Study-the-Treatment-Effects-of-tAN-for-Alcohol-Withdrawal-Symptoms.html

Spark Biomedical Awarded an NIH Grant to Study the To deepen the understanding of the neural mechanisms involved, the trial will track key clinical outcomes: 1) alcohol withdrawal symptoms using ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8437143/

Effect of Transcutaneous Auricular Vagus Nerve Stimulation ... These results suggest that taVNS could improve the depression symptoms and sleep quality in alcohol-dependent patients after withdrawal.

7. bioelecmed.biomedcentral.com bioelecmed.biomedcentral.com/articles/10.1186/s42234-022-00095-x

Delivering transcutaneous auricular neurostimulation (tAN) to ... Across all study participants, tAN demonstrated to be safe, well-tolerated, and delivered clinically meaningful, rapid, and sustained reductions ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S1094715925006981

Noninvasive Vagus Nerve Stimulation Reduces ... Clinical studies also show that cervical nVNS reduces withdrawal-related symptoms associated with opioid use, including anxiety, subjective ...

9. frontiersin.org frontiersin.org/journals/human-neuroscience/articles/10.3389/fnhum.2021.648556/full

Transcutaneous Auricular Neurostimulation (tAN): A Novel ... Across all study participants, tAN was shown to be safe, well-tolerated, and seemed to facilitate the rapid weaning of oral morphine. The results also suggest ...