Acute and Residual Effects of Caffeinated Beer

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.

Study Overview

• Status: Completed
• Conditions: Neurobehavioral Manifestations; Alcohol Intoxication; Drug Related Sleep Disturbance
• Intervention / Treatment: Drug: Caffeinated Alcoholic Beer; Other: Non-Caffeinated Alcoholic Beer; Drug: Caffeinated Non-Alcoholic Beer; Other: Non-Caffeinated, Non-Alcoholic Beer

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.

• Study Type: Interventional
• Enrollment (Actual): 154
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • General Clinical Research Center, Boston Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 30 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1Caffeinated Alcoholic Beer; Caffeinated Alcoholic beer	Drug: Caffeinated Alcoholic Beer; Alcoholic Beer plus Caffeine Citrate powder.; Other Names: 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 Names: 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 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

Collaborators and Investigators

• Sponsor: Boston University
• Collaborators: Brown University; University of Michigan; Centers for Disease Control and Prevention
• Investigators: Principal Investigator: Jonathan Howland, PhD, MPH, Boston University

Publications and helpful links

General Publications

• Howland J, Rohsenow DJ, Arnedt JT, Bliss CA, Hunt SK, Calise TV, Heeren T, Winter M, Littlefield C, Gottlieb DJ. The acute effects of caffeinated versus non-caffeinated alcoholic beverage on driving performance and attention/reaction time. Addiction. 2011 Feb;106(2):335-41. doi: 10.1111/j.1360-0443.2010.03219.x. Epub 2010 Dec 6.

Study record dates

Study Major Dates

• Study Start: October 1, 2006
• Primary Completion (Actual): October 1, 2009
• Study Completion (Actual): October 1, 2009

Study Registration Dates

• First Submitted: August 9, 2007
• First Submitted That Met QC Criteria: August 10, 2007
• First Posted (Estimate): August 13, 2007

Study Record Updates

• Last Update Posted (Actual): June 28, 2017
• Last Update Submitted That Met QC Criteria: May 26, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Alcohol; Caffeine; Reaction Time; Alcohol Consumption; Family History; Driving Simulation; Residual Effects; Psychomotor Vigilance Test
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Nervous System Diseases; Alcohol-Related Disorders; Substance-Related Disorders; Sleep Wake Disorders; Neurologic Manifestations; Dyssomnias; Parasomnias; Neurobehavioral Manifestations; Alcoholic Intoxication; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Purinergic Antagonists; Purinergic Agents; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Dopamine Agents; Dopamine Uptake Inhibitors; Phosphodiesterase Inhibitors; Purinergic P1 Receptor Antagonists; Central Nervous System Stimulants; Sympathomimetics; Adrenergic Uptake Inhibitors; Methamphetamine; Caffeine
• Other Study ID Numbers: H-26002; R49CE000946 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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