Acute and Residual Effects of Caffeinated Beer

• Sponsor: Boston University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00515294
• Collaborator: Brown University (Other), University of Michigan (Other), Centers for Disease Control and Prevention (U.S. Fed)
• Enrollment: 154
• Location: 1
• Arms: 4
• Duration (Months): 36
• Patients Per Site Per Month: 4.3

Study Details

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.

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

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 Design

• Study Type: Interventional
• Actual Enrollment: 154 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Other
• Official Title: Acute and Residual Effects of Beer VS. Caffeinated Beer On Simulated Driving
• Study Start Date: Oct 1, 2006
• Actual Primary Completion Date: Oct 1, 2009
• Actual Study Completion Date: Oct 1, 2009

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Lane Position Deviation [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

1. Psycho-motor Vigilance Test (PVT) [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 30 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Boston University
• ClinicalTrials.gov Identifier: NCT00515294
• Other Study ID Numbers: H-26002; R49CE000946
• First Posted: Aug 13, 2007
• Last Update Posted: Jun 28, 2017
• Last Verified: May 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• 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; Parasomnias; Neurobehavioral Manifestations; Alcoholic Intoxication; Caffeine; Methamphetamine

Study Results

Participant Flow

Recruitment Details	Recruited via newspaper ads and social media.

Arm/Group Title	1Caffeinated Alcoholic Beer	2Non-Caffeinated Alcoholic Beer	3Caffeinated Non-Alcoholic Beer	4Non-Alcoholic, Non-Caffeinated Beer
Arm/Group Description	Caffeinated Alcoholic Beer: Alcoholic Beer plus Caffeine Citrate powder.	Non-Caffeinated Alcoholic Beer: Alcoholic Non-Caffeinated Beer	Caffeinated Non-Alcoholic Beer: Non-Alcoholic Beer plus Caffeine Citrate powder.	Non-Caffeinated, Non-Alcoholic Beer: Non-Alcoholic Beer
Period Title: Overall Study
STARTED	38	39	38	39
COMPLETED	29	36	27	35
NOT COMPLETED	9	3	11	4

Baseline Characteristics

Arm/Group Title	1Caffeinated Alcoholic Beer	2Non-Caffeinated Alcoholic Beer	3Caffeinated Non-Alcoholic Beer	4Non-Alcoholic, Non-Caffeinated Beer	Total
Arm/Group Description	Caffeinated Alcoholic Beer: Alcoholic Beer plus Caffeine Citrate powder.	Non-Caffeinated Alcoholic Beer: Alcoholic Non-Caffeinated Beer	Caffeinated Non-Alcoholic Beer: Non-Alcoholic Beer plus Caffeine Citrate powder.	Non-Caffeinated, Non-Alcoholic Beer: Non-Alcoholic Beer	Total of all reporting groups
Overall Participants	29	36	27	35	127
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	29 100%	36 100%	27 100%	35 100%	127 100%
>=65 years	0 0%	0 0%	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	14 48.3%	17 47.2%	13 48.1%	16 45.7%	60 47.2%
Male	15 51.7%	19 52.8%	14 51.9%	19 54.3%	67 52.8%
Race/Ethnicity, Customized (Count of Participants)
Asian	3 10.3%	5 13.9%	3 11.1%	5 14.3%	16 12.6%
Black/African American	1 3.4%	2 5.6%	0 0%	1 2.9%	4 3.1%
White	22 75.9%	27 75%	20 74.1%	26 74.3%	95 74.8%
More than one race	0 0%	1 2.8%	2 7.4%	2 5.7%	5 3.9%
Unknown, not reported	3 10.3%	1 2.8%	2 7.4%	1 2.9%	7 5.5%
Region of Enrollment (participants) [Number]
United States	29 100%	36 100%	27 100%	35 100%	127 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Driver simulator did not work properly for 6 participants. Their data are not included.

Arm/Group Title	1Caffeinated Alcoholic Beer	2Non-Caffeinated Alcoholic Beer	3Caffeinated Non-Alcoholic Beer	4Non-Alcoholic, Non-Caffeinated Beer
Arm/Group Description	Caffeinated Alcoholic Beer: Alcoholic Beer plus Caffeine Citrate powder.	Non-Caffeinated Alcoholic Beer: Alcoholic Non-Caffeinated Beer	Caffeinated Non-Alcoholic Beer: Non-Alcoholic Beer plus Caffeine Citrate powder.	Non-Caffeinated, Non-Alcoholic Beer: Non-Alcoholic Beer
Measure Participants	28	35	26	32
Mean (Standard Deviation) [feet]	-1.25 (.61)	-1.36 (.85)	-1.22 (.53)	-1.21 (.77)

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	1Caffeinated Alcoholic Beer	2Non-Caffeinated Alcoholic Beer	3Caffeinated Non-Alcoholic Beer	4Non-Alcoholic, Non-Caffeinated Beer
Arm/Group Description	Caffeinated Alcoholic Beer: Alcoholic Beer plus Caffeine Citrate powder.	Non-Caffeinated Alcoholic Beer: Alcoholic Non-Caffeinated Beer	Caffeinated Non-Alcoholic Beer: Non-Alcoholic Beer plus Caffeine Citrate powder.	Non-Caffeinated, Non-Alcoholic Beer: Non-Alcoholic Beer
Measure Participants	29	36	27	35
Mean (Standard Deviation) [milliseconds]	278.7 (46.6)	293.3 (47.0)	233.1 (22.3)	241.8 (25.6)

Adverse Events

Time Frame	3 years
Arm/Group Title	1Caffeinated Alcohol		2Non-Caffeinated Alcohol		3Caffeinated Non-Alcoholic Beer		4Non-Alcoholic, Non-Caffeinated Beer
Arm/Group Description	Caffeinated Alcoholic Beer: Alcoholic Beer plus Caffeine Citrate powder.		Non-Caffeinated Alcoholic Beer: Alcoholic Non-Caffeinated Beer		Caffeinated Non-Alcoholic Beer: Non-Alcoholic Beer plus Caffeine Citrate powder.		Non-Caffeinated, Non-Alcoholic Beer: Non-Alcoholic Beer
All Cause Mortality
	1Caffeinated Alcohol		2Non-Caffeinated Alcohol		3Caffeinated Non-Alcoholic Beer		4Non-Alcoholic, Non-Caffeinated Beer
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/29 (0%)		0/36 (0%)		0/27 (0%)		0/35 (0%)
Serious Adverse Events
	1Caffeinated Alcohol		2Non-Caffeinated Alcohol		3Caffeinated Non-Alcoholic Beer		4Non-Alcoholic, Non-Caffeinated Beer
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/29 (0%)		0/36 (0%)		0/27 (0%)		0/35 (0%)
Other (Not Including Serious) Adverse Events
	1Caffeinated Alcohol		2Non-Caffeinated Alcohol		3Caffeinated Non-Alcoholic Beer		4Non-Alcoholic, Non-Caffeinated Beer
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/29 (0%)		0/36 (0%)		0/27 (0%)		0/35 (0%)

Limitations/Caveats

Difficulties with the driver simulator resulted in invalid data for 6 participants so their results were not included in the lane position deviation results. Inaccurate caffeine doses resulted in exclusion of 12 participants from the trial.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.