Manipulation of Breath Alcohol Tests: Can Specific Techniques Alter Blood Alcohol Concentration Readings?

Alcohol Intoxication Clinical Trial

Official title:

Manipulation of Breath Alcohol Tests: Can Specific Techniques Alter Blood Alcohol Concentration Readings?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02580318
• Other study ID #: SLHN 2015-28
• Status: Completed
• Phase: N/A
• First received: September 10, 2015
• Last updated: September 11, 2017
• Start date: August 2015
• Est. completion date: December 2015

Study information

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

Clinical Trial Summary

This is a prospective cohort study. The investigators will enroll 50 healthy volunteers. In a safe environment and after signing informed consent, each participant will consume a standardized alcoholic beverage. Using a Breathalyzer, the subjects BAT will be measured. If the subject's BAT is less than 0.10 +/- 0.005, the subject will drink another alcoholic beverage. This process will continue until the subject's BAT is 0.10 +/- 0.005. The number of alcoholic beverages the subject consumes will be monitored by the observers. When the target BAT is reached, the subjects will manipulate the breathalyzer in various ways and measure their BAT again after each manipulation. In a set order, the subjects will manipulate the breathalyzer by using less than the subject's maximal exhalation effort, placing the breathalyzer at the side of the subject's mouth, hyperventilating (10 rapidly (less than 1 second) and successive breaths prior to using the device), repeating breathalyzer 5 minutes and 10 minutes after hyperventilation and then drinking cold water after the breathalyzer at 10 minutes and repeating the breathalyzer after drinking some cold water. Descriptive statistical analyses as well as Pearson's product moment correlation coefficient will be employed to determine if any statistically significant correlation exists for any of the manipulations.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• 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:

• healthy volunteers over age 21

Exclusion Criteria:

• pregnancy

• alcoholism

• diabetes

• kidney/bladder stones

• kidney disease

• liver disease

• stomach ulcer

• organ transplant patients

• dialysis patients

• subjects with alcohol allergies

• subjects taking the following medications: activated charcoal, ampicillin, carbamazepine, cephaloridine, cloxacillin, methicillin, nitroglycerine, oxacillin, penicillin G, or quinicillin

Related Conditions & MeSH terms

• Alcohol Concentration Values
• Alcohol Intoxication
• Alcoholic Intoxication

Intervention

Device:
• breathalyzer

Locations

Country	Name	City	State
United States	St. Luke's 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)

Jones AW. Quantitative measurements of the alcohol concentration and the temperature of breath during a prolonged exhalation. Acta Physiol Scand. 1982 Mar;114(3):407-12. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Alcohol Concentration Measured by Breathalyzer		20 minutes