Use of tAN® in Alcohol Withdrawal Management

Erin Deneke

Status: Enrolling

Conditions: Alcohol Withdrawal

Treatments: Device: Transcutaneous Auricular Neurostimulation (tAN)

Study type: Interventional

Funder types: Other

Identifiers

NCT06771037

Caron001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups

Active Transcutaneous Auricular Neurostimulation (tAN)

Experimental group

Description:

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.

Treatment:

Device: Transcutaneous Auricular Neurostimulation (tAN)

Sham Transcutaneous Auricular Neurostimulation (tAN)

Sham Comparator group

Description:

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.

Treatment:

Device: Transcutaneous Auricular Neurostimulation (tAN)