Acute and Residual Effects of Caffeinated Beer

Study Overview
=================
Brief 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.

Official Title
-----------------
Acute and Residual Effects of Beer VS. Caffeinated Beer On Simulated Driving

Conditions
-----------------
Neurobehavioral Manifestations, Drug Related Sleep Disturbance, Alcohol Intoxication

Intervention / Treatment
-----------------
* Drug: Caffeinated Alcoholic Beer
* Other: Non-Caffeinated Alcoholic Beer
* Drug: Caffeinated Non-Alcoholic Beer
* Other: Non-Caffeinated, Non-Alcoholic Beer


Participation Criteria
=================
Eligibility 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.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 30 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1Caffeinated Alcoholic Beer<br>Caffeinated Alcoholic beer | Drug: Caffeinated Alcoholic Beer<br>* Alcoholic Beer plus Caffeine Citrate powder.<br>* Other names: 69mg caffeine/12oz glass of regular beer;|
| Active Comparator: 2Non-Caffeinated Alcoholic Beer<br>Non-Caffeinated Alcoholic beer | Other: Non-Caffeinated Alcoholic Beer<br>* Alcoholic Non-Caffeinated Beer<br>|
| Active Comparator: 3Caffeinated Non-Alcoholic Beer<br>Caffeinated Non-Alcoholic Beer | Drug: Caffeinated Non-Alcoholic Beer<br>* Non-Alcoholic Beer plus Caffeine Citrate powder.<br>* Other names: 69mg caffeine/12oz glass of non-alcoholic beer;|
| Placebo Comparator: 4Non-Caffeinated, Non-Alcoholic Beer<br>Non-Caffeinated, Non-Alcoholic Beer | Other: Non-Caffeinated, Non-Alcoholic Beer<br>* Non-Alcoholic Beer<br>* Other names: Placebo;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lane Position Deviation | 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 | 30 minutes post dosing | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psycho-motor Vigilance Test (PVT) | 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. | 30 minutes post dosing | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Caffeine, Alcohol, Alcohol Consumption, Residual Effects, Family History, Psychomotor Vigilance Test, Driving Simulation, Reaction Time