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Acute and Residual Effects of Caffeinated Beer

This study has been completed.
Sponsor:
Collaborators:
Brown University
University of Michigan
Centers for Disease Control and Prevention
Information provided by (Responsible Party):
Boston University
ClinicalTrials.gov Identifier:
NCT00515294
First received: August 9, 2007
Last updated: May 26, 2017
Last verified: May 2017
  Purpose
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.

Condition Intervention Phase
Neurobehavioral Manifestations Drug Related Sleep Disturbance Alcohol Intoxication Drug: Caffeinated Alcoholic Beer Other: Non-Caffeinated Alcoholic Beer Drug: Caffeinated Non-Alcoholic Beer Other: Non-Caffeinated, Non-Alcoholic Beer Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Participant, Care Provider, Investigator
Primary Purpose: Other
Official Title: Acute and Residual Effects of Beer VS. Caffeinated Beer On Simulated Driving

Further study details as provided by Boston University:

Primary Outcome Measures:
  • Lane Position Deviation [ Time Frame: 30 minutes post dosing ]
    The reported lane position deviation indicates the position of the car relative to the center line in feet in the driver simulator. A deviation of 0 indicates no deviation from the center line (the car is positioned farthest from the road edge). Negative numbers indicate deviations to the right of the center line with the car positioned within the lane closer to the road edge. Positive numbers indicate deviations to the left of the center line with the car positioned in the lane of oncoming traffic closer to the road edge


Secondary Outcome Measures:
  • Psycho-motor Vigilance Test (PVT) [ Time Frame: 30 minutes post dosing ]
    Participants completed 10 test trials to assess their psycho-motor response using a hand held box that randomly starts a scroll of numbers in milliseconds and as soon as it starts to scroll the participant needs to press a button to stop the scrolling. The mean and standard deviations for the 10 tests were calculated as a single outcome score for each study arm. Response times were measured in milliseconds. The lower the number of milliseconds the faster the response to the random stimuli.


Enrollment: 154
Study Start Date: October 2006
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1Caffeinated Alcoholic Beer
Caffeinated Alcoholic beer
Drug: Caffeinated Alcoholic Beer
Alcoholic Beer plus Caffeine Citrate powder.
Other Name: 69mg caffeine/12oz glass of regular beer
Active Comparator: 2Non-Caffeinated Alcoholic Beer
Non-Caffeinated Alcoholic beer
Other: Non-Caffeinated Alcoholic Beer
Alcoholic Non-Caffeinated Beer
Active Comparator: 3Caffeinated Non-Alcoholic Beer
Caffeinated Non-Alcoholic Beer
Drug: Caffeinated Non-Alcoholic Beer
Non-Alcoholic Beer plus Caffeine Citrate powder.
Other Name: 69mg caffeine/12oz glass of non-alcoholic beer
Placebo Comparator: 4Non-Caffeinated, Non-Alcoholic Beer
Non-Caffeinated, Non-Alcoholic Beer
Other: Non-Caffeinated, Non-Alcoholic Beer
Non-Alcoholic Beer
Other Name: Placebo

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.

  Eligibility

Ages Eligible for Study:   21 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00515294

Locations
United States, Massachusetts
General Clinical Research Center, Boston Medical Center
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Boston University
Brown University
University of Michigan
Centers for Disease Control and Prevention
Investigators
Principal Investigator: Jonathan Howland, PhD, MPH Boston University
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Boston University
ClinicalTrials.gov Identifier: NCT00515294     History of Changes
Other Study ID Numbers: H-26002
R49CE000946 ( U.S. NIH Grant/Contract )
Study First Received: August 9, 2007
Results First Received: March 6, 2017
Last Updated: May 26, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Boston University:
Caffeine
Alcohol
Alcohol Consumption
Residual Effects
Family History
Psychomotor Vigilance Test
Driving Simulation
Reaction Time

Additional relevant MeSH terms:
Dyssomnias
Sleep Wake Disorders
Parasomnias
Neurobehavioral Manifestations
Alcoholic Intoxication
Nervous System Diseases
Mental Disorders
Neurologic Manifestations
Signs and Symptoms
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Caffeine
Central Nervous System Stimulants
Physiological Effects of Drugs
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on July 21, 2017