The Impact of Oral Ethanol and Vaped Ethanol on the Evaluation of Impairment

Electronic Cigarette Use Clinical Trial

Official title:

The Impact of Oral Ethanol and Vaped Ethanol on the Evaluation of Impairment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04522973
• Other study ID #: HM20018402
• Secondary ID: 2018-75-CX-0036
• Status: Recruiting
• Phase: N/A
• Start date: April 21, 2023
• Est. completion date: July 2024

Study information

• Verified date: December 2023
• Source: Virginia Commonwealth University
• Contact: Alison Breland, PhD
• Phone: 8048273562
• Email: ctsp[@]vcu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this research study is to find out about ethanol-containing e-cigarettes impact ethanol breath tests, field sobriety tests, or other tests of sobriety. Ethanol is a common part of e-cigarette liquids.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 55 Years

Eligibility

Inclusion Criteria:

• e-cigarette users
• willing to provide informed consent
• able to attend the lab sessions as needed
• agree to use designated products according to study protocol.

Exclusion Criteria:

• Women who are breast-feeding or test positive for pregnancy (by urinalysis) at screening.
• Some study details about the eligibility criteria are purposely omitted at this time to preserve scientific integrity. Full details will be posted at the conclusion of the stud

Related Conditions & MeSH terms

• Electronic Cigarette Use

Intervention

Other:
• Beverage with ethanol and E-cigarette liquid with ethanol
Beverage with ethanol and E-cigarette liquid with ethanol
• Beverage with ethanol and E-cigarette liquid without ethanol
Beverage with ethanol and E-cigarette liquid without ethanol
• Beverage without ethanol and E-cigarette liquid with ethanol
Beverage without ethanol and E-cigarette liquid with ethanol
• Beverage without ethanol and E-cigarette liquid without ethanol
Beverage without ethanol and E-cigarette liquid without ethanol

Locations

Country	Name	City	State
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Virginia Commonwealth University	U.S. Department of Justice

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Direct Effects of Vaping Questionnaire	Questionnaire that asks participants about their vaping experience (10 questions, each scored from 0 - 100)	Administered after e-cigarette use (at 90 and 250 minutes after e-cigarette use)
Other	Biphasic Alcohol Effects Scale	Questionnaire that asks participants about effects associated with alcohol use (14 questions, each scored from 0 - 10)	Conducted before and after the e-cigarette is used by the participant (change from baseline at 90 and 250 minutes after e-cigarette use)
Other	General Labeled Magnitude Scale	Questionnaire that asks participants about flavor sensation, harshness/irritancy, and "throat hit" of the e-cigarette (3 questions, each scored from 0 - 100)	Administered after e-cigarette use (at 90 and 250 minutes after e-cigarette use)
Primary	Change in preliminary ethanol breath level	Preliminary ethanol breath level will be assessed using a probationary breath test or PBT, which involves blowing through a tube.	Conducted before and after the e-cigarette is used by the participant, at multiple time points (change from baseline reading at 45, 55, 125, 155, 200, 250, 280 minutes after e-cigarette use)
Primary	Standard Field Sobriety Test	Test used to determine sobriety	Conducted before and after the e-cigarette is used by the participant, at multiple time points (change from baseline at 55, 90, and 250 minutes after e-cigarette use)