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tAN for Substance Use Disorder
Sponsor: Spark Biomedical, Inc.
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.
Official title: Study of Transcutaneous Auricular Neurostimulation as a Treatment for Substance Use Disorder
Key Details
Gender
All
Age Range
18 Years - 64 Years
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2026-01-28
Completion Date
2026-08-31
Last Updated
2026-04-08
Healthy Volunteers
No
Conditions
Interventions
Sparrow 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.
Sparrow 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