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Acute and Residual Effects of Caffeinated Beer

Primary Purpose

Neurobehavioral Manifestations, Drug Related Sleep Disturbance, Alcohol Intoxication

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Caffeinated Alcoholic Beer
Non-Caffeinated Alcoholic Beer
Caffeinated Non-Alcoholic Beer
Non-Caffeinated, Non-Alcoholic Beer
Sponsored by
Boston University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Neurobehavioral Manifestations focused on measuring Caffeine, Alcohol, Alcohol Consumption, Residual Effects, Family History, Psychomotor Vigilance Test, Driving Simulation, Reaction Time

Eligibility Criteria

21 Years - 30 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • General Clinical Research Center, Boston Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

1Caffeinated Alcoholic Beer

2Non-Caffeinated Alcoholic Beer

3Caffeinated Non-Alcoholic Beer

4Non-Caffeinated, Non-Alcoholic Beer

Arm Description

Caffeinated Alcoholic beer

Non-Caffeinated Alcoholic beer

Caffeinated Non-Alcoholic Beer

Non-Caffeinated, Non-Alcoholic Beer

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
August 9, 2007
Last Updated
May 26, 2017
Sponsor
Boston University
Collaborators
Brown University, University of Michigan, Centers for Disease Control and Prevention
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1. Study Identification

Unique Protocol Identification Number
NCT00515294
Brief Title
Acute and Residual Effects of Caffeinated Beer
Official Title
Acute and Residual Effects of Beer VS. Caffeinated Beer On Simulated Driving
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
October 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston University
Collaborators
Brown University, University of Michigan, Centers for Disease Control and Prevention

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neurobehavioral Manifestations, Drug Related Sleep Disturbance, Alcohol Intoxication
Keywords
Caffeine, Alcohol, Alcohol Consumption, Residual Effects, Family History, Psychomotor Vigilance Test, Driving Simulation, Reaction Time

7. Study Design

Primary Purpose
Other
Study Phase
Phase 1, Phase 2
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
154 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1Caffeinated Alcoholic Beer
Arm Type
Experimental
Arm Description
Caffeinated Alcoholic beer
Arm Title
2Non-Caffeinated Alcoholic Beer
Arm Type
Active Comparator
Arm Description
Non-Caffeinated Alcoholic beer
Arm Title
3Caffeinated Non-Alcoholic Beer
Arm Type
Active Comparator
Arm Description
Caffeinated Non-Alcoholic Beer
Arm Title
4Non-Caffeinated, Non-Alcoholic Beer
Arm Type
Placebo Comparator
Arm Description
Non-Caffeinated, Non-Alcoholic Beer
Intervention Type
Drug
Intervention Name(s)
Caffeinated Alcoholic Beer
Other Intervention Name(s)
69mg caffeine/12oz glass of regular beer
Intervention Description
Alcoholic Beer plus Caffeine Citrate powder.
Intervention Type
Other
Intervention Name(s)
Non-Caffeinated Alcoholic Beer
Intervention Description
Alcoholic Non-Caffeinated Beer
Intervention Type
Drug
Intervention Name(s)
Caffeinated Non-Alcoholic Beer
Other Intervention Name(s)
69mg caffeine/12oz glass of non-alcoholic beer
Intervention Description
Non-Alcoholic Beer plus Caffeine Citrate powder.
Intervention Type
Other
Intervention Name(s)
Non-Caffeinated, Non-Alcoholic Beer
Other Intervention Name(s)
Placebo
Intervention Description
Non-Alcoholic Beer
Primary Outcome Measure Information:
Title
Lane Position Deviation
Description
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
Time Frame
30 minutes post dosing
Secondary Outcome Measure Information:
Title
Psycho-motor Vigilance Test (PVT)
Description
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.
Time Frame
30 minutes post dosing

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan Howland, PhD, MPH
Organizational Affiliation
Boston University
Official's Role
Principal Investigator
Facility Information:
Facility Name
General Clinical Research Center, Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
21134017
Citation
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.
Results Reference
derived

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Acute and Residual Effects of Caffeinated Beer

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