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:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2025-12-25 @ 2:28 AM
NCT ID:
NCT03567434
Eligibility Criteria:
Inclusion Criteria:
* Men and women age 21 - 40 years
* Binge drinkers as defined by a pattern of consuming ≥4 drinks if female (≥5 drinks if males) in ≤ 2 hours on more than one occasion within the past 6 months, and at least once in the past 30 days. The National Institute of Alcohol Abuse and Alcoholism (NIAAA) definition of a "drink" will be used.
* Women must be eumenorrheic and premenopausal with regular and consistent menstrual cycles (i.e., \~25-30 days ovarian/uterine cycles that include 2-7 days of menstruation)
* Willingness to abstain from exercise and caffeine at least 12 hours prior to any autonomic and cardiovascular testing, and abstain from alcohol 24 hours prior to any autonomic and cardiovascular testing (unless experimentally administered).
Exclusion Criteria:
* Body mass index ≥ 35 kg/m2
* Smokers
* A physician diagnosis of diabetes
* Pregnancy
* Taking any cardiovascular medications
* Severe obstructive sleep apnea as determined by an apnea-hypopnea index of ≥ 30 episodes per hour
* Moderate-to-severe Alcohol Use Disorder (AUD) as determined by the Diagnostic and Statistical Manual of Mental Disorders (DSM-V)
* Individuals suspected to have mutant alcohol dehydrogenase 2 (ALDH2) isoenzyme as determined using a validated flushing questionnaire
* Women using hormonal contraceptives (i.e., oral, intrauterine, etc.) in the prior 6 months
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
40 Years
Study:
NCT03567434
Study Brief:
Protocol Section:
NCT03567434