Acute and Residual Effects of Caffeinated Beer (NCT00515294) | Clinical Trial Compass
CompletedPhase 1/2
Acute and Residual Effects of Caffeinated Beer
United States154 participantsStarted 2006-10
Plain-language summary
The aim of this study is to develop information about the acute and residual effects of a new product being targeted to young adults. Using a double placebo-controlled 2 X 2 factorial model study design, we will compare the acute and residual effects on driving impairment of caffeinated alcohol, non-caffeinated alcohol, caffeinated placebo, and non-caffeinated placebo. Under the alcohol conditions, participants will receive sufficient alcoholic beverage to attain a blood alcohol concentration (BAC) of .12 g%. Participants will be 144 undergraduate and graduate students, and recent college graduates.
Who can participate
Age range21 Years – 30 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 zo…