Acute and Residual Effects of Caffeinated Beer
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|ClinicalTrials.gov Identifier: NCT00515294|
Recruitment Status : Completed
First Posted : August 13, 2007
Results First Posted : June 28, 2017
Last Update Posted : June 28, 2017
|Condition or disease||Intervention/treatment||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|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||154 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Acute and Residual Effects of Beer VS. Caffeinated Beer On Simulated Driving|
|Study Start Date :||October 2006|
|Actual Primary Completion Date :||October 2009|
|Actual Study Completion Date :||October 2009|
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
Other Name: Placebo
- 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
- 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.
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00515294
|United States, Massachusetts|
|General Clinical Research Center, Boston Medical Center|
|Boston, Massachusetts, United States, 02118|
|Principal Investigator:||Jonathan Howland, PhD, MPH||Boston University|