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

Not Applicable

Completed

• Conditions: Electronic Cigarette Use
• Interventions: Other: Beverage with ethanol and E-cigarette liquid with ethanol; Other: Beverage with ethanol and E-cigarette liquid without ethanol; Other: Beverage without ethanol and E-cigarette liquid with ethanol; Other: Beverage without ethanol and E-cigarette liquid without ethanol

• Registration Number: NCT04522973
• Lead Sponsor: Virginia Commonwealth University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-08-13
• Study First Submitted QC: 2020-08-18
• Study First Posted: 2020-08-21
• Study Start: 2023-04-21
• Primary Completion: 2024-07-18
• Study Completion: 2024-07-18
• Status Verified: 2024-09
• Last Update Submitted: 2024-09-30
• Last Update Posted: 2024-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Within group four condition comparison	Beverage without ethanol and E-cigarette liquid without ethanol	On four separate occasions, participants will come to the research center and complete one of the four conditions. All participants will complete all four study conditions. Sessions will be ordered by Latin-square. Participants will not be assigned to arms based on session order and session order will not be recorded as it is not relevant to the study outcomes.
Within group four condition comparison	Beverage with ethanol and E-cigarette liquid without ethanol	On four separate occasions, participants will come to the research center and complete one of the four conditions. All participants will complete all four study conditions. Sessions will be ordered by Latin-square. Participants will not be assigned to arms based on session order and session order will not be recorded as it is not relevant to the study outcomes.
Within group four condition comparison	Beverage with ethanol and E-cigarette liquid with ethanol	On four separate occasions, participants will come to the research center and complete one of the four conditions. All participants will complete all four study conditions. Sessions will be ordered by Latin-square. Participants will not be assigned to arms based on session order and session order will not be recorded as it is not relevant to the study outcomes.
Within group four condition comparison	Beverage without ethanol and E-cigarette liquid with ethanol	On four separate occasions, participants will come to the research center and complete one of the four conditions. All participants will complete all four study conditions. Sessions will be ordered by Latin-square. Participants will not be assigned to arms based on session order and session order will not be recorded as it is not relevant to the study outcomes.

Primary Outcome Measures

Name	Time	Method
Change in preliminary ethanol breath level	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)	Preliminary ethanol breath level will be assessed using a probationary breath test or PBT, which involves blowing through a tube.
Standard Field Sobriety Test	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)	Test used to determine sobriety

Trial Locations

Locations (1)

Virginia Commonwealth University; 🇺🇸 Richmond, Virginia, United States