Alcohol Intoxication Clinical Trial
Official title:
Acute and Residual Effects of Beer VS. Caffeinated Beer On Simulated Driving
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.
Caffeinated alcoholic beverages target young adults with the promise that the caffeine will
counteract the sedating effects of alcohol and thus let the consumer remain alert and active
longer, while continuing to drink. It is likely that in the minds of some young people, this
promise also translates into the idea that mixing caffeine with alcohol allows one to drive
more safely than would be possible after having consumed an equivalent amount of
non-caffeinated alcoholic beverage. These are dangerous assumptions because (1) alertness
may not indicate the absence of impairment under intoxication and (2) next-day impairment
from the residual effects of heavy drinking may be exacerbated by mixing caffeine and
alcohol. We will compare the acute and residual effects of caffeinated and non-caffeinated
beer in terms of a highly relevant outcome - the ability to drive safely.
The long-term objectives of this program of research are to investigate factors that predict
or contribute to performance decrements after alcohol ingestion, with a focus on behaviors
most relevant to public health, such as driving. The primary specific aims of the proposed
work are:
AIM 1: To compare the acute effects of caffeinated alcohol, non-caffeinated alcohol,
caffeinated placebo, and non-caffeinated placebo on driving-related impairment, as measured
by performance on a driving simulator and the Psychomotor Vigilance Test (PVT), a test of
sustained attention/reaction time. We hypothesize that caffeinated beverage will result in
less impaired simulated driving ability and better PVT performance acutely, compared to
non-caffeinated beverage, but that performance on these measures following both caffeinated
and non-caffeinated beverage be impaired relative to placebo beverages.
AIM 2: To compare the residual effects of caffeinated alcohol, non-caffeinated alcohol,
caffeinated placebo, and non-caffeinated placebo on next-day driving-related impairment, as
measured by a driving simulator and the PVT. We hypothesize that caffeinated beverage will
result in greater impairment in next-day simulated driving and attention/reaction time,
relative to non-caffeinated beverage, and that performance following both caffeinated and
non-caffeinated alcoholic beverages will be impaired relative to corresponding placebo
beverages.
AIM 3: To compare the acute effects of caffeinated alcohol, non-caffeinated alcohol,
caffeinated placebo, and non-caffeinated placebo on self-rated ability to drive, as measured
by a self assessment of ability-to-drive questionnaire, and estimate of blood alcohol
concentration (BAC). We hypothesize that caffeinated alcoholic beverages will result in
greater confidence in ability to drive and lower estimates of BAC, compared to
non-caffeinated alcoholic beverages, but that for both alcoholic beverages, confidence in
driving ability will be lower and estimates of BAC will be greater, relative to placebos.
AIM 4: To compare the residual effects of caffeinated alcohol, non-caffeinated alcohol,
caffeinated placebo, and non-caffeinated placebo on self-rated ability to drive. We
hypothesize that caffeinated alcoholic beverage will result in lower confidence in ability
to drive and higher estimates of BAC, compared to non-caffeinated alcoholic beverage, but
that for both alcoholic beverages, confidence in driving ability will be lower and estimates
of BAC will be greater, relative to placebo.
;
Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator)
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