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

Alcohol Intoxication Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02722564
• Other study ID #: SLHN 2015-26
• Status: Completed
• Phase: N/A
• First received: October 16, 2015
• Last updated: May 11, 2017
• Start date: August 2015
• Est. completion date: December 2015

Study information

• Verified date: May 2017
• Source: St. Luke's Hospital and Health Network, Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Alcohol Intoxication
• Alcoholic Intoxication

Intervention

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

Locations

Country	Name	City	State
United States	St. Luke's University Hospital	Bethlehem	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
St. Luke's Hospital and Health Network, Pennsylvania

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 day