Trial Outcomes & Findings for Accuracy of Self-estimation of Blood Alcohol Concentration Compared to Object Values (NCT NCT02722564)

Results Overview

The change was measured both when participants' breath alcohol content was ascending to 0.1 and descending to 0.08.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

55 participants

Primary outcome timeframe

1 day

Results posted on

2017-05-15

Participant milestones
Measure	All Study Participants subject will self estimate breath alcohol content after each beer ingested self estimation of breath alcohol content record breath alcohol content as measured by breathalyzer drink a beer: drink a beer, repeat until breath alcohol content 0.1
Overall Study STARTED	55
Overall Study COMPLETED	55
Overall Study NOT COMPLETED	0

Withdrawal data not reported

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort
Measure	All Study Participants n=55 Participants subject will self estimate breath alcohol content after each beer ingested self estimation of breath alcohol content record breath alcohol content as measured by breathalyzer drink a beer: drink a beer, repeat until breath alcohol content 0.1
Age, Categorical <=18 years	0 Participants n=55 Participants
Age, Categorical Between 18 and 65 years	55 Participants n=55 Participants
Age, Categorical >=65 years	0 Participants n=55 Participants
Sex: Female, Male Female	22 Participants n=55 Participants
Sex: Female, Male Male	33 Participants n=55 Participants
Region of Enrollment United States	55 participants n=55 Participants

Timeframe: 1 day

Population: The number analyzed for ascending BrAC readings and descending BrAC readings

The change was measured both when participants' breath alcohol content was ascending to 0.1 and descending to 0.08.

Outcome measures
Measure	All Study Participants n=587 BrAC readings subject will self estimate breath alcohol content after each beer ingested self estimation of breath alcohol content record breath alcohol content as measured by breathalyzer drink a beer: drink a beer, repeat until breath alcohol content 0.1
Change in Breath Alcohol Content Between the Estimated Level and the Actual Level as Measured by an Alco Sensor IV Device BrAC ascending to 0.1	0.01 percent blood alcohol content Standard Deviation 0.02
Change in Breath Alcohol Content Between the Estimated Level and the Actual Level as Measured by an Alco Sensor IV Device BrAC descending to 0.08	-0.01 percent blood alcohol content Standard Deviation 0.04

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Adverse event data not reported

Other adverse events
Measure	All Study Participants n=55 participants at risk subject will self estimate breath alcohol content after each beer ingested self estimation of breath alcohol content record breath alcohol content as measured by breathalyzer drink a beer: drink a beer, repeat until breath alcohol content 0.1
Gastrointestinal disorders vomiting	9.1% 5/55 • Number of events 5 • 12 hours
Ear and labyrinth disorders vertigo	5.5% 3/55 • Number of events 3 • 12 hours

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