Trials / Recruiting
RecruitingNCT07281261
tAN for Substance Use Disorder
Study of Transcutaneous Auricular Neurostimulation as a Treatment for Substance Use Disorder
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- Sponsor
- Spark Biomedical, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 64 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Alcohol Use Disorder
- Alcohol Abuse
- Substance Use Disorders
- Substance Use Disorders Alcohol Use Withdrawal State
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | 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. |
| DEVICE | 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. |
Timeline
- Start date
- 2026-01-28
- Primary completion
- 2026-08-31
- Completion
- 2026-08-31
- First posted
- 2025-12-15
- Last updated
- 2026-04-08
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT07281261. Inclusion in this directory is not an endorsement.