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The Impact of Vaping Ethanol in the Evaluation of Impairment

The Impact of Vaping Ethanol in the Evaluation of Impairment

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03826303
Enrollment
17
Registered
2019-02-01
Start date
2021-04-02
Completion date
2022-04-08
Last updated
2022-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Electronic Cigarette Use

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.

Interventions

OTHERE-cigarette liquid with ethanol, 1 puff

E-cigarette liquid with ethanol, 1 puff

OTHERE-cigarette liquid without ethanol, 1 puff

E-cigarette liquid without ethanol, 1 puff

OTHERE-cigarette liquid with ethanol, 10 puffs

E-cigarette liquid with ethanol, 10 puffs

OTHERE-cigarette liquid without ethanol, 10 puffs

E-cigarette liquid without ethanol, 10 puffs

Sponsors

U.S. Department of Justice
CollaboratorFED
Virginia Commonwealth University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Preliminary breath test for ethanolConducted 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)
Evidentiary breath test for ethanolConducted 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)
Standard Field Sobriety TestConducted 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

Other

MeasureTime frameDescription
Direct Effects of Vaping QuestionnaireAdministered after e-cigarette use (at 39 minutes after e-cigarette use)Questionnaire that asks participants about their vaping experience (10 questions, each scored from 0 - 100)
Biphasic Alcohol Effects ScaleConducted before and after the e-cigarette is used by the participant (change from baseline at 39 and 54 minutes after e-cigarette use)Questionnaire that asks participants about effects associated with alcohol use (14 questions, each scored from 0 - 10)
General Labeled Magnitude ScaleAdministered after e-cigarette use (at 39 minutes after e-cigarette use)Questionnaire that asks participants about flavor sensation, harshness/irritancy, and throat hit of the e-cigarette (3 questions, each scored from 0 - 100)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026