Acute and Residual Effects of Caffeinated Beer
Condition: Neurobehavioral Manifestations; Drug Related Sleep Disturbance; Alcohol Intoxication
MeSH terms: Dyssomnias; Parasomnias; Neurobehavioral Manifestations; Alcoholic Intoxication
Study type: Interventional
Phase: Phase 1/Phase 2

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.
    

Detailed description: 
      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.
    

Intervention name(s): Caffeinated Alcoholic Beer; Non-Caffeinated Alcoholic Beer; Caffeinated Non-Alcoholic Beer; Non-Caffeinated, Non-Alcoholic Beer
Intervention type(s): Drug; Other; Drug; Other
Intervention description(s): Alcoholic Beer plus Caffeine Citrate powder.; Alcoholic Non-Caffeinated Beer; Non-Alcoholic Beer plus Caffeine Citrate powder.; Non-Alcoholic Beer
Other intervention name(s): 69mg caffeine/12oz glass of regular beer; 69mg caffeine/12oz glass of non-alcoholic beer; Placebo
Intervention MeSH terms: Caffeine; Methamphetamine
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other
Keywords: Caffeine; Alcohol; Alcohol Consumption; Residual Effects; Family History; Psychomotor Vigilance Test; Driving Simulation; Reaction Time