RecruitingNot ApplicableNCT07281261

tAN for Substance Use Disorder

Study of Transcutaneous Auricular Neurostimulation as a Treatment for Substance Use Disorder


Sponsor

Spark Biomedical, Inc.

Enrollment

20 participants

Start Date

Jan 28, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

The study will involve a 5-day tAN treatment to attenuate alcohol withdrawal syndrome (AWS) and alter resting state functional connectivity (RSFC) between OFC and striatum in patients with alcohol use disorder (AUD). Enrolled participants will wear the tAN device on-site (at The Menninger Clinic) for the 5-day detox treatment period. Participants with AUD will be single-blinded randomized into 2 groups - a treatment group (active tAN) and a placebo group (sham tAN). Each group will consist of five separate time points - admission, screening, baseline, tAN treatment, and post tAN treatment. Clinical measures collected before, during, and after treatment will include alcohol withdrawal severity, craving, benzodiazepine usage, and assessments of depression and suicidal behaviors. Participants will undergo MRI scans before and after the treatment period to assess changes in brain connectivity and their relationship to clinical outcomes.


Eligibility

Min Age: 18 YearsMax Age: 64 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Sparrow Ascent and a medical device called Sparrow Ascent (Sham) for people with alcohol abuse, alcohol use disorder, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 64 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICESparrow Ascent

The Sparrow Ascent is an FDA-cleared (K230796) wearable, battery-operated, neurostimulation system designed to transcutaneously stimulate nerves on and around the auricle. The system is comprised of a Patient Controller, cable, and 24-hour disposable earpiece.

DEVICESparrow Ascent (Sham)

Participants will have the earpiece applied and the cable connected to the Patient Controller, but tAN stimulation will not be turned on. The sham device has an identical appearance to the active device.


Locations(1)

The Menninger Clinic

Houston, Texas, United States

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NCT07281261


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