Use of tAN® in Alcohol Withdrawal Management

Part of paid clinical trials in Wernersville, Pennsylvania.

Sponsor
Erin Deneke
Study ID
NCT06771037
Status
Recruiting
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Conditions

  • Alcohol Withdrawal

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • 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 Details

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.

Key Dates

Start date
Apr 21, 2025
Status verified
Apr 2025
Primary completion
Mar 1, 2027
Completion
Jul 1, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Active Transcutaneous Auricular Neurostimulation (tAN)
    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.
  • Sham Comparator: Sham Transcutaneous Auricular Neurostimulation (tAN)
    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.

Primary Outcome Measure

Clinical Institute Withdrawal Assessment Scale, Revised (CIWA-Ar) score [ Time Frame: Baseline to end of study day 5 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Caron Treatment CentersWernersvillePennsylvania19565
Erin Deneke, Ph.D.
[email protected]
610-743-6242

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By research site
Caron Treatment Centers· Wernersville, PA

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