Alcohol Intoxication
Conditions
Brief summary
This will be a prospective survey study. The participants will all be volunteers of legal drinking age. Each participant will consume one alcoholic beverage (beer) at a time and then will be asked to verbally estimate their current blood alcohol concentration and if the subject feels they are able to drive. At that time, their BAC level will be measured objectively using a breath alcohol test (BAT) device. The participant will not be told their objective value. This will continue with a verbal estimate and actual BAT reading after every drink until the participant reaches a minimum BAC of 0.10. At this time, participants will continue to be monitored until their BAC falls to 0.08 and they are clinically sober. As their blood alcohol level decreases, the investigators will ask the participant to estimate their level every hour along with an actual reading until reaching 0.08. Statistical analyses will be used to determine how accurate self estimation is in regards to blood alcohol content.
Interventions
BEHAVIORALself estimation of breath alcohol content
DEVICEbreath alcohol content as measured by Alco Sensor IV device
OTHERdrink a beer
drink a beer, repeat until breath alcohol content 0.1
Sponsors
St. Luke's Hospital and Health Network, Pennsylvania
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
SINGLE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* over the legal age (21years old) to drink alcohol.
Exclusion criteria
* Volunteers will be excluded from the study if they suffer from any of the following conditions: Alcoholism, Diabetes, Kidney/bladder stones, Kidney disease, Liver disease, Stomach ulcer, Organ transplant patients, Dialysis patients, and patients with alcohol allergies.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Breath Alcohol Content Between the Estimated Level and the Actual Level as Measured by an Alco Sensor IV Device | 1 day | The change was measured both when participants' breath alcohol content was ascending to 0.1 and descending to 0.08. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 55 |
| Total | 55 |
Baseline characteristics
| Characteristic | All Study Participants | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 55 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 55 participants | — |
| Sex: Female, Male Female | 22 Participants | — |
| Sex: Female, Male Male | 33 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 8 / 55 |
| serious Total, serious adverse events | 0 / 55 |
Outcome results
Primary
Change in Breath Alcohol Content Between the Estimated Level and the Actual Level as Measured by an Alco Sensor IV Device
The change was measured both when participants' breath alcohol content was ascending to 0.1 and descending to 0.08.
Time frame: 1 day
Population: The number analyzed for ascending BrAC readings and descending BrAC readings
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| All Study Participants | 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 |
| All Study Participants | 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 |
p-value: <0.001t-test, 2 sided
p-value: <0.0001t-test, 2 sided