Trial Outcomes & Findings for Acute and Residual Effects of Caffeinated Beer (NCT NCT00515294)

Last Updated: 2017-06-28

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

154 participants

Primary outcome timeframe

30 minutes post dosing

Results posted on

2017-06-28

Participant Flow

Recruited via newspaper ads and social media.

Participant milestones

Participant milestones
Measure	1Caffeinated Alcoholic Beer Caffeinated Alcoholic Beer: Alcoholic Beer plus Caffeine Citrate powder.	2Non-Caffeinated Alcoholic Beer Non-Caffeinated Alcoholic Beer: Alcoholic Non-Caffeinated Beer	3Caffeinated Non-Alcoholic Beer Caffeinated Non-Alcoholic Beer: Non-Alcoholic Beer plus Caffeine Citrate powder.	4Non-Alcoholic, Non-Caffeinated Beer Non-Caffeinated, Non-Alcoholic Beer: Non-Alcoholic Beer
Overall Study STARTED	38	39	38	39
Overall Study COMPLETED	29	36	27	35
Overall Study NOT COMPLETED	9	3	11	4

Reasons for withdrawal

Reasons for withdrawal
Measure	1Caffeinated Alcoholic Beer Caffeinated Alcoholic Beer: Alcoholic Beer plus Caffeine Citrate powder.	2Non-Caffeinated Alcoholic Beer Non-Caffeinated Alcoholic Beer: Alcoholic Non-Caffeinated Beer	3Caffeinated Non-Alcoholic Beer Caffeinated Non-Alcoholic Beer: Non-Alcoholic Beer plus Caffeine Citrate powder.	4Non-Alcoholic, Non-Caffeinated Beer Non-Caffeinated, Non-Alcoholic Beer: Non-Alcoholic Beer
Overall Study Lost to Follow-up	3	2	3	1
Overall Study Driver simulator problems	1	1	1	3
Overall Study Caffeine amount inaccurate	5	0	7	0

Baseline Characteristics

Acute and Residual Effects of Caffeinated Beer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	1Caffeinated Alcoholic Beer n=29 Participants Caffeinated Alcoholic Beer: Alcoholic Beer plus Caffeine Citrate powder.	2Non-Caffeinated Alcoholic Beer n=36 Participants Non-Caffeinated Alcoholic Beer: Alcoholic Non-Caffeinated Beer	3Caffeinated Non-Alcoholic Beer n=27 Participants Caffeinated Non-Alcoholic Beer: Non-Alcoholic Beer plus Caffeine Citrate powder.	4Non-Alcoholic, Non-Caffeinated Beer n=35 Participants Non-Caffeinated, Non-Alcoholic Beer: Non-Alcoholic Beer	Total n=127 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	29 Participants n=5 Participants	36 Participants n=7 Participants	27 Participants n=5 Participants	35 Participants n=4 Participants	127 Participants n=21 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Sex: Female, Male Female	14 Participants n=5 Participants	17 Participants n=7 Participants	13 Participants n=5 Participants	16 Participants n=4 Participants	60 Participants n=21 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	19 Participants n=7 Participants	14 Participants n=5 Participants	19 Participants n=4 Participants	67 Participants n=21 Participants
Race/Ethnicity, Customized Race · Asian	3 Participants n=5 Participants	5 Participants n=7 Participants	3 Participants n=5 Participants	5 Participants n=4 Participants	16 Participants n=21 Participants
Race/Ethnicity, Customized Race · Black/African American	1 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	4 Participants n=21 Participants
Race/Ethnicity, Customized Race · White	22 Participants n=5 Participants	27 Participants n=7 Participants	20 Participants n=5 Participants	26 Participants n=4 Participants	95 Participants n=21 Participants
Race/Ethnicity, Customized Race · More than one race	0 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	5 Participants n=21 Participants
Race/Ethnicity, Customized Race · Unknown, not reported	3 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	7 Participants n=21 Participants
Region of Enrollment United States	29 participants n=5 Participants	36 participants n=7 Participants	27 participants n=5 Participants	35 participants n=4 Participants	127 participants n=21 Participants

PRIMARY outcome

Timeframe: 30 minutes post dosing

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

Outcome measures

Outcome measures
Measure	1Caffeinated Alcoholic Beer n=28 Participants Caffeinated Alcoholic Beer: Alcoholic Beer plus Caffeine Citrate powder.	2Non-Caffeinated Alcoholic Beer n=35 Participants Non-Caffeinated Alcoholic Beer: Alcoholic Non-Caffeinated Beer	3Caffeinated Non-Alcoholic Beer n=26 Participants Caffeinated Non-Alcoholic Beer: Non-Alcoholic Beer plus Caffeine Citrate powder.	4Non-Alcoholic, Non-Caffeinated Beer n=32 Participants Non-Caffeinated, Non-Alcoholic Beer: Non-Alcoholic Beer
Lane Position Deviation	-1.25 feet Standard Deviation .61	-1.36 feet Standard Deviation .85	-1.22 feet Standard Deviation .53	-1.21 feet Standard Deviation .77

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	1Caffeinated Alcoholic Beer n=29 Participants Caffeinated Alcoholic Beer: Alcoholic Beer plus Caffeine Citrate powder.	2Non-Caffeinated Alcoholic Beer n=36 Participants Non-Caffeinated Alcoholic Beer: Alcoholic Non-Caffeinated Beer	3Caffeinated Non-Alcoholic Beer n=27 Participants Caffeinated Non-Alcoholic Beer: Non-Alcoholic Beer plus Caffeine Citrate powder.	4Non-Alcoholic, Non-Caffeinated Beer n=35 Participants Non-Caffeinated, Non-Alcoholic Beer: Non-Alcoholic Beer
Psycho-motor Vigilance Test (PVT)	278.7 milliseconds Standard Deviation 46.6	293.3 milliseconds Standard Deviation 47.0	233.1 milliseconds Standard Deviation 22.3	241.8 milliseconds Standard Deviation 25.6

Adverse Events

1Caffeinated Alcohol

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

2Non-Caffeinated Alcohol

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

3Caffeinated Non-Alcoholic Beer

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

4Non-Alcoholic, Non-Caffeinated Beer

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jonathan Howland, Professor

Boston University

Phone: 617 638 5158

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place