Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:20 PM
Ignite Modification Date:
2025-12-24 @ 12:20 PM
NCT ID:
NCT07281261
Eligibility Criteria:
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 \[CIWA-Ar\] \> 15 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
64 Years
Study:
NCT07281261
Study Brief:
Protocol Section:
NCT07281261