Back to resultsAccuracy of Self-estimation of Blood Alcohol Concentration Compared to Object Values
Primary Purpose
Alcohol Intoxication
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
self estimation of breath alcohol content
breath alcohol content as measured by Alco Sensor IV device
drink a beer
Sponsored by
About this trial
This is an interventional basic science trial for Alcohol Intoxication
Eligibility Criteria
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.
Sites / Locations
- St. Luke's University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
all study participants
Arm Description
subject will self estimate breath alcohol content and their actual BrAC will be recorded as measured by the Alco Sensor IV after each beer ingested.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02722564
First Posted
October 16, 2015
Last Updated
May 11, 2017
Sponsor
St. Luke's Hospital and Health Network, Pennsylvania
1. Study Identification
Unique Protocol Identification Number
NCT02722564
Brief Title
Accuracy of Self-estimation of Blood Alcohol Concentration Compared to Object Values
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
August 2015 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Luke's Hospital and Health Network, Pennsylvania
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Intoxication
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Single
Allocation
N/A
Enrollment
55 (Actual)
8. Arms, Groups, and Interventions
Arm Title
all study participants
Arm Type
Experimental
Arm Description
subject will self estimate breath alcohol content and their actual BrAC will be recorded as measured by the Alco Sensor IV after each beer ingested.
Intervention Type
Behavioral
Intervention Name(s)
self estimation of breath alcohol content
Intervention Type
Device
Intervention Name(s)
breath alcohol content as measured by Alco Sensor IV device
Intervention Type
Other
Intervention Name(s)
drink a beer
Intervention Description
drink a beer, repeat until breath alcohol content 0.1
Primary Outcome Measure Information:
Title
Change in Breath Alcohol Content Between the Estimated Level and the Actual Level as Measured by an Alco Sensor IV Device
Description
The change was measured both when participants' breath alcohol content was ascending to 0.1 and descending to 0.08.
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
St. Luke's University Hospital
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18015
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
16205367
Citation
Kraus CL, Salazar NC, Mitchell JR, Florin WD, Guenther B, Brady D, Swartzwelder SH, White AM. Inconsistencies between actual and estimated blood alcohol concentrations in a field study of college students: do students really know how much they drink? Alcohol Clin Exp Res. 2005 Sep;29(9):1672-6. doi: 10.1097/01.alc.0000179205.24180.4a.
Results Reference
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Learn more about this trial
Accuracy of Self-estimation of Blood Alcohol Concentration Compared to Object Values
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