tAN for Substance Use Disorder

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Alcohol Use Disorder, Alcohol Abuse, Substance Use Disorders, Substance Use Disorders Alcohol Use Withdrawal State

In brief

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.

Key facts

Study ID

NCT07281261

Run by

Spark Biomedical, Inc.

People needed

20

Starts

2026-01-28

Expected to finish

2026-08-31

Last updated by the study team

2026-06-02

Who can join

Age: 18 and older, up to 64. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female (evenly recruited) aged 18-64 years old
• Meeting DSM-5 criteria of moderate or above AUD at screening using the structured clinical interview for DSM-5 (SCID-5)
• Demonstration of at least moderate risk of alcohol use at screening using the WHO-ASSIST
• Demonstration of high risk for moderate to severe alcohol withdrawal syndrome (Prediction of Alcohol Withdrawal Severity Scale [PAWSS] > 4 at admission)
• Demonstration of severe withdrawal symptoms (Clinical Institute Withdrawal Assessment of Alcohol Scale, Revised [CIWA-Ar] ≥ 8 at screening)
• Positive urine test for alcohol at screening
• Be able to provide written informed consent
• Female subjects must be non-nursing and not pregnant
• Meet the MRI safety screening form provided by the Center for Advanced MR Imaging (CAMRI) at BCM.

You may not qualify if…

• 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
• Current use of tobacco
• Is pregnant or nursing
• Contraindications to MRI (pacemaker, cochlear implants, metal in eyes, other metal implants, etc.)
• Do not meet the pre-screening MRI questions provided by the Center for Advanced MR Imaging (CAMRI) at BCM

Where it is running

• The Menninger Clinic — Houston, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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