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 @ 5:14 PM
Ignite Modification Date:
2025-12-24 @ 5:14 PM
NCT ID:
NCT03489850
Eligibility Criteria:
Inclusion Criteria:
1. Age between 21 and 45
2. Meet DSM-5 criteria for current Moderate-to-Severe AUD
3. Current Heavy Drinking (\> 14 drinks per week for men; \> 7 drinks per week for women), as indicated by self-reported drinking for the 30 days prior to screening
4. Have reliable internet access
Exclusion Criteria:
1. Currently receiving or seeking treatment for AUD\*
2. Past year DSM-5 diagnosis of any substance use disorder other than alcohol or nicotine
3. A lifetime diagnosis of schizophrenia, bipolar disorder, or any psychotic disorder
4. Current use of drugs, other than marijuana, verified by a urine toxicology screen\*
5. Pregnant, nursing, or refusal to use reliable birth control (if female)\*
6. A medical condition that may interfere with safe participation (e.g., unstable cardiac, renal, or liver disease, uncontrolled hypertension, diabetes, or AST, ALT, or GGT ≥ 3 times upper normal limit)
7. Self-reported recent (i.e. past 30 day) use of medications that are contraindicated with ibudilast\*
8. Non-removable ferromagnetic objects in body
9. Claustrophobia
10. Serious head injury or prolonged period of unconsciousness (\>30 minutes)
* Participants who meet these criteria at any point during the course of the study (i.e. after randomization) will be withdrawn from the study for safety purposes.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
45 Years
Study:
NCT03489850
Study Brief:
Protocol Section:
NCT03489850