Clinical trial NCT06771037: Use of tAN® in Alcohol Withdrawal Management
Official title: The Use of Non-invasive Transcutaneous Auricular Neurostimulation (tAN®) in Alcohol Withdrawal Management
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alcohol Withdrawal
Keywords: Alcohol withdrawal
tAN
transcutaneous auricular neurostimulation
Lead sponsor: Caron Treatment Centers
Sponsor class: OTHER
First posted: 2025-01-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Clinical Institute Withdrawal Assessment Scale, Revised (CIWA-Ar) score
timeFrame: Baseline to end of study day 5
measure: Amount of comfort medications utilized
timeFrame: Baseline to end of study day 5
Secondary outcomes:
measure: Change in ambient alcohol craving
timeFrame: Baseline to end of study day 5
measure: Change in objective sleep
timeFrame: Baseline to end of study day 5
measure: Change in subjective sleep
timeFrame: Baseline to end of study day 5
Other outcomes:
measure: Change in mood
timeFrame: Baseline to end of study day 5
Locations:
city: Wernersville
country: United States
facility: Caron Treatment Centers
state: Pennsylvania
Study officials:
affiliation: Caron Treatment Centers
name: Erin Deneke, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.