Acute and Residual Effects of Caffeinated Beer
Completed · Phase 1/Phase 2 · Has a placebo group
Conditions studied: Neurobehavioral Manifestations, Drug Related Sleep Disturbance, Alcohol Intoxication
In brief
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.
Key facts
- Study ID
- NCT00515294
- Run by
- Boston University
- People needed
- 154
- Starts
- 2006-10-01
- Expected to finish
- 2009-10-01
- Last updated by the study team
- 2017-06-28
Who can join
Age: 21 and older, up to 30. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- General Clinical Research Center, Boston Medical Center — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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