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 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.

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.

Is transcutaneous auricular neurostimulation (tAN) safe for humans?

The research on auricular transcutaneous vagus nerve stimulation (atVNS), a similar technique, suggests it is generally safe for humans, as it can be used like an earpiece without medical supervision. However, specific safety data for tAN in alcohol withdrawal is not detailed in the available studies. ^{1 2 3 4 5}

How does transcutaneous auricular neurostimulation (tAN) differ from other treatments for alcohol withdrawal?

Transcutaneous auricular neurostimulation (tAN) is unique because it is a non-invasive treatment that involves stimulating the ear to influence brain activity, unlike traditional pharmacological treatments. It can be used without medical supervision and may enhance cognitive control, which is crucial for maintaining abstinence from alcohol. ^{1 2 3 5 6}

What data supports the effectiveness of the treatment Transcutaneous Auricular Neurostimulation (tAN) for alcohol withdrawal?

Research suggests that transcutaneous auricular neurostimulation (tAN) has been effective in managing opioid withdrawal symptoms, which indicates it might also help with alcohol withdrawal. Additionally, similar treatments like auricular acupuncture have shown potential in reducing symptoms of alcohol withdrawal, suggesting that tAN could be beneficial as well. ^{1 2 3 6 7}

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 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]

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]

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. England pubmed.ncbi.nlm.nih.gov

Ear acupuncture for alcohol withdrawal in comparison with aromatherapy: a randomized-controlled trial. [2016]

2. United States pubmed.ncbi.nlm.nih.gov

Auricular transcutaneous vagus nerve stimulation for alcohol use disorder: A chance to improve treatment? [2022]

3. England pubmed.ncbi.nlm.nih.gov

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

4. England pubmed.ncbi.nlm.nih.gov

Delivering transcutaneous auricular neurostimulation (tAN) to improve symptoms associated with opioid withdrawal: results from a prospective clinical trial. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Acupuncture for alcohol withdrawal: a randomized controlled trial. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Electroacupuncture Relieves Pain During Alcohol Withdrawal. [2021]

7. Singapore pubmed.ncbi.nlm.nih.gov

Acupuncture reduces alcohol withdrawal syndrome and c-Fos expression in rat brain. [2013]