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 @ 7:09 PM
Ignite Modification Date:
2025-12-24 @ 7:09 PM
NCT ID:
NCT06426303
Eligibility Criteria:
Inclusion Criteria:
* 18-60 years old
* Veteran enrolled in VHA healthcare
Alcohol Group:
* must meet diagnosis for recent alcohol-use disorder (DSM-V)
* willing to return for follow-up visits and can participate for 12-weeks
Control Group:
* must not meet DSM-V criteria for a use disorder other than nicotine
Exclusion Criteria:
* Clinically significant neurological, endocrine, hepatic, or systemic disease that would compromise safe participation or confound outcomes
* Left-handedness
* Axis-1 psychiatric diagnoses other than anxiety, depression or post-traumatic stress disorder
* Recreational or prescriptive use of psychotropic medications
* Recreational or prescriptive use of opioid medications or have a past or current history of abuse or dependence on opioids
* MRI contraindications (e.g. metal in body)
* Positive urine drug screen, except for nicotine and marijuana, on test days
* Women who are pregnant or breastfeeding
* Participants on hormonal therapy or treatments other than pregnancy contraceptives
* Autoimmune or neurodegenerative diseases that present with neuroinflammation (multiple sclerosis, amyotrophic lateral sclerosis, Alzheimer's, Parkinson's)
* Current participation in an investigational drug study
* Alcohol group: \< 5 days and \> 3 weeks of abstinence from alcohol
* Alcohol group: Liver disease requiring medication or medical treatment, and/or aspartate or alanine aminotransferase levels greater than 3 times the upper limit of normal, gastrointestinal or renal disease that would significantly impair absorption, metabolism or excretion of study drug, or require medical treatment.
* Non-english speaker
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT06426303
Study Brief:
Protocol Section:
NCT06426303