Accuracy of Self-estimation of Blood Alcohol Concentration Compared to Object Values

• Sponsor: St. Luke's Hospital and Health Network, Pennsylvania (Other)
• Overall Status: Completed
• CT.gov ID: NCT02722564
• Collaborator: (none)
• Enrollment: 55
• Location: 1
• Arm: 1
• Duration (Months): 4
• Patients Per Site Per Month: 13.7

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Alcohol Intoxication	Behavioral: self estimation of breath alcohol content; Device: breath alcohol content as measured by Alco Sensor IV device; Other: drink a beer	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 55 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: Single
• Primary Purpose: Basic Science
• Study Start Date: Aug 1, 2015
• Actual Primary Completion Date: Dec 1, 2015
• Actual Study Completion Date: Dec 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: all study participants 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.	Behavioral: self estimation of breath alcohol content; Device: breath alcohol content as measured by Alco Sensor IV device; Other: drink a beer; drink a beer, repeat until breath alcohol content 0.1

Outcome Measures

Primary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	St. Luke's University Hospital	Bethlehem	Pennsylvania	United States	18015

Sponsors and Collaborators

• St. Luke's Hospital and Health Network, Pennsylvania

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.

• Responsible Party: Holly Stankewicz, D.O., attending physician and faculty emergency medicine resiency, St. Luke's Hospital and Health Network, Pennsylvania
• ClinicalTrials.gov Identifier: NCT02722564
• Other Study ID Numbers: SLHN 2015-26
• First Posted: Mar 30, 2016
• Last Update Posted: May 15, 2017
• Last Verified: May 1, 2017

• Additional relevant MeSH terms: Alcoholic Intoxication; Ethanol

Study Results

Participant Flow

Arm/Group Title	All Study Participants
Arm/Group Description	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
Period Title: Overall Study
STARTED	55
COMPLETED	55
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	All Study Participants
Arm/Group Description	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 Participants	55
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	55 100%
>=65 years	0 0%
Sex: Female, Male (Count of Participants)
Female	22 40%
Male	33 60%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (participants) [Number]
United States	55 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

The number analyzed for ascending BrAC readings and descending BrAC readings

Arm/Group Title	All Study Participants
Arm/Group Description	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
Measure Participants	55
Measure BrAC readings	587
BrAC ascending to 0.1	0.01 (0.02)
BrAC descending to 0.08	-0.01 (0.04)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	All Study Participants
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p value associated with the change between estimated and actual BrAC when the participants BrAC was ascending to 0.1.
	Method	t-test, 2 sided
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	All Study Participants
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	p value associated with change between estimated and actual BrAC as participants BrAC descended to 0.08.
	Method	t-test, 2 sided
	Comments

Adverse Events

Time Frame	12 hours
Arm/Group Title	All Study Participants
Arm/Group Description	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
All Cause Mortality
	All Study Participants
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	All Study Participants
	Affected / at Risk (%)	# Events
Total	0/55 (0%)
Other (Not Including Serious) Adverse Events
	All Study Participants
	Affected / at Risk (%)	# Events
Total	8/55 (14.5%)
Ear and labyrinth disorders
vertigo	3/55 (5.5%)	3
Gastrointestinal disorders
vomiting	5/55 (9.1%)	5

Limitations/Caveats

[Not Specified]

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.