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

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ClinicalTrials.gov Identifier: NCT02722564
Recruitment Status : Completed
First Posted : March 30, 2016
Results First Posted : May 15, 2017
Last Update Posted : May 15, 2017
Sponsor:
Information provided by (Responsible Party):
Holly Stankewicz, D.O., 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.

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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Intervention Model: Single Group Assignment
Masking: Single
Primary Purpose: Basic Science
Study Start Date : August 2015
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

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




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 [ Time Frame: 1 day ]
    The change was measured both when participants' breath alcohol content was ascending to 0.1 and descending to 0.08.



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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02722564


Locations
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United States, Pennsylvania
St. Luke's University Hospital
Bethlehem, Pennsylvania, United States, 18015
Sponsors and Collaborators
St. Luke's Hospital and Health Network, Pennsylvania

Publications:
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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     History of Changes
Other Study ID Numbers: SLHN 2015-26
First Posted: March 30, 2016    Key Record Dates
Results First Posted: May 15, 2017
Last Update Posted: May 15, 2017
Last Verified: May 2017

Additional relevant MeSH terms:
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Alcoholic Intoxication
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs