tAN for Substance Use Disorder (NCT07281261) | Clinical Trial Compass
RecruitingNot Applicable
tAN for Substance Use Disorder
United States20 participantsStarted 2026-01-28
Plain-language 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.
Who can participate
Age range18 Years – 64 Years
SexALL
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Inclusion criteria
✓. 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 \[CIWA-Ar\] \> 15 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
Exclusion criteria
✕. 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
What they're measuring
1
Clinical Institute Withdrawal Assessment of Alcohol Scale, Revised (CIWA-Ar)
Timeframe: Every 4 hours during the tAN treatment (Days 2-6)
2
Average benzodiazepine use
Timeframe: Every 4 hours during the tAN treatment (Days 2-6)