The Impact of Vaping Ethanol in the Evaluation of Impairment

Not Applicable

Completed

• Conditions: Electronic Cigarette Use
• Interventions: Other: E-cigarette liquid without ethanol, 10 puffs; Other: E-cigarette liquid without ethanol, 1 puff; Other: E-cigarette liquid with ethanol, 1 puff; Other: E-cigarette liquid with ethanol, 10 puffs

• Registration Number: NCT03826303
• 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: 2019-01-30
• Study First Submitted QC: 2019-01-30
• Study First Posted: 2019-02-01
• Study Start: 2021-04-02
• Status Verified: 2022-04
• Primary Completion: 2022-04-08
• Study Completion: 2022-04-08
• Last Update Submitted: 2022-04-11
• Last Update Posted: 2022-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

• Individuals must be e-cigarette users who are 21-65, willing to provide informed consent, attend the lab sessions as needed. Participants must agree to use designated products according to study protocol.

Exclusion Criteria

• Women will be excluded if they 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 study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
E-cigarette without ethanol, 10 puffs	E-cigarette liquid without ethanol, 10 puffs	-
E-cigarette without ethanol, 1 puff	E-cigarette liquid without ethanol, 1 puff	-
E-cigarette with ethanol, 1 puff	E-cigarette liquid with ethanol, 1 puff	-
E-cigarette with ethanol, 10 puffs	E-cigarette liquid with ethanol, 10 puffs	-

Primary Outcome Measures

Name	Time	Method
Preliminary breath test for ethanol	Conducted before and after the e-cigarette is used by the participant, at multiple time points (change from baseline reading at 27, 35, 40, 45, and 56 minutes after e-cigarette use)	Initial type of breath test used (gives percent blood alcohol concentration)
Standard Field Sobriety Test	Conducted before and after the e-cigarette is used by the participant, at multiple time points (change from baseline at 30 and 49 minutes after e-cigarette use)	Test used to determine sobriety
Evidentiary breath test for ethanol	Conducted before and after the e-cigarette is used by the participant, at multiple time points (change from baseline at 29, 37, 42, 47, and 58 minutes after e-cigarette use)	Secondary type of breath test used (gives percent blood alcohol concentration)

Trial Locations

Locations (1)

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