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

May 11, 2017 updated by: Holly Stankewicz, D.O., St. Luke's Hospital and Health Network, Pennsylvania
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

55

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States, 18015
        • St. Luke's University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Breath Alcohol Content Between the Estimated Level and the Actual Level as Measured by an Alco Sensor IV Device
Time Frame: 1 day
The change was measured both when participants' breath alcohol content was ascending to 0.1 and descending to 0.08.
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Luke's Hospital and Health Network, Pennsylvania

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2015

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

October 16, 2015

First Submitted That Met QC Criteria

March 23, 2016

First Posted (Estimate)

March 30, 2016

Study Record Updates

Last Update Posted (Actual)

May 15, 2017

Last Update Submitted That Met QC Criteria

May 11, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SLHN 2015-26

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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