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 @ 1:31 AM
Ignite Modification Date:
2025-12-25 @ 1:31 AM
NCT ID:
NCT00515294
Eligibility Criteria:
Inclusion Criteria:
* College students, graduate students, or recent graduates
* Between the ages of 21 and 30 years inclusive (as verified by valid drivers license)
* Who, if a student, reports good academic standing
* Have not been diagnosed with a sleep disorder
* Are not daily smokers
* At least occasionally in the past month, consume five drinks (for men) or more (four or more if female \[based on Flannery et al 2002\]) during a single drinking episode
* Have a valid drivers license, so as to include only people who know how to drive.
Exclusion Criteria:
* Scores of 5 or more on a screening measure for alcoholism (the short version of the Michigan Alcohol Screening Test \[SMAST\])
* A history of counseling or treatment for chronic substance abuse by self-report
* Daily smoker (to mitigate confounding of caffeine by nicotine withdrawal, or acute nicotine administration, smokers will be excluded from participation)
* Current use of medications that affect the sleep/wake cycle or daytime alertness or that are contraindicated for alcohol
* Presence of a health condition that contraindicates alcohol
* Diagnosis of a sleep disorder (sleep apnea, narcolepsy, periodic limb movement, restless legs syndrome, circadian rhythm disorder, and insomnia)
* Use of recreational drugs (e.g., marijuana) while participating in the study
* Working overnight shifts
* Female and pregnant, nursing, or not using reliable birth control
* Participants who have traveled across two or more time zones in the last month will be rescheduled for later participation (minimum of 1 month from time-zone travel)
* On average consume greater than 4 cups of coffee per day (\>400 mg/day)
* Participants who report ever getting motion sick during screening or become motion sick after practicing on the driving simulator during Session 1.
* Weigh more than 230 Lbs.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
30 Years
Study:
NCT00515294
Study Brief:
Protocol Section:
NCT00515294