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

Not Applicable

Completed

• Conditions: Alcohol Intoxication
• Interventions: Behavioral: self estimation of breath alcohol content; Device: breath alcohol content as measured by Alco Sensor IV device; Other: drink a beer

• Registration Number: NCT02722564
• Lead Sponsor: St. Luke's Hospital and Health Network, Pennsylvania

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-08
• Study First Submitted: 2015-10-16
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Study First Submitted QC: 2016-03-23
• Study First Posted: 2016-03-30
• Status Verified: 2017-05
• Results First Submitted: 2017-05-11
• Results First Submitted QC: 2017-05-11
• Last Update Submitted: 2017-05-11
• Results First Posted: 2017-05-15
• Last Update Posted: 2017-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
all study participants	self estimation of breath alcohol content	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.
all study participants	drink a beer	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.
all study participants	breath alcohol content as measured by Alco Sensor IV device	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.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

St. Luke's University Hospital; 🇺🇸 Bethlehem, Pennsylvania, United States