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NCT07281261NARecruiting

tAN for Substance Use Disorder

Spark Biomedical, Inc.

Start Date

1/28/2026

Completion Date

8/31/2026

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 Criteria

Age Range: 18 years to 64 years

Inclusion Criteria: 1. Male or female (evenly recruited) aged 18-64 years old 2. Meeting DSM-5 criteria of moderate or above AUD at screening using the structured clinical interview for DSM-5 (SCID-5) 3. Demonstration of at least moderate risk of alcohol use at screening using the WHO-ASSIST 4. Demonstration of high risk for moderate to severe alcohol withdrawal syndrome (Prediction of Alcohol Withdrawal Severity Scale \[PAWSS\] \> 4 at admission) 5. Demonstration of severe withdrawal symptoms (Clinical Institute Withdrawal Assessment of Alcohol Scale, Revised \[CIWA-Ar\] ≥ 8 at screening) 6. Positive urine test for alcohol at screening 7. Be able to provide written informed consent 8. Female subjects must be non-nursing and not pregnant 9. Meet the MRI safety screening form provided by the Center for Advanced MR Imaging (CAMRI) at BCM. Exclusion Criteria: 1. In the opinion of the clinician and the research team at admission, be expected to fail to complete the study protocol due to probably relocation from The Menninger Clinic area or not tolerable to receive tAN 2. Current use of tobacco 3. Is pregnant or nursing 4. Contraindications to MRI (pacemaker, cochlear implants, metal in eyes, other metal implants, etc.) 5. Do not meet the pre-screening MRI questions provided by the Center for Advanced MR Imaging (CAMRI) at BCM

Interventions

DEVICE

Sparrow Ascent

DEVICE

Sparrow Ascent (Sham)

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Conditions

Alcohol Use DisorderAlcohol AbuseSubstance Use DisordersSubstance Use Disorders Alcohol Use Withdrawal State

Locations

The Menninger Clinic

Houston, Texas 77035

United States