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Completed

NCT Number: NCT03826303

The Impact of Vaping Ethanol in the Evaluation of Impairment

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.

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Key information

Conditions

Electronic Cigarette Use Behavior Smoking Vaping

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

E-cigarette liquid with ethanol, 1 puff

Other

E-cigarette liquid with ethanol, 1 puff

E-cigarette liquid without ethanol, 1 puff

Other

E-cigarette liquid without ethanol, 1 puff

E-cigarette liquid with ethanol, 10 puffs

Other

E-cigarette liquid with ethanol, 10 puffs

E-cigarette liquid without ethanol, 10 puffs

Other

E-cigarette liquid without ethanol, 10 puffs

Primary outcomes

  1. Preliminary breath test for ethanol

    Time frame: 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)

  2. Evidentiary breath test for ethanol

    Time frame: 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)

  3. Standard Field Sobriety Test

    Time frame: 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

Other outcomes

  1. Direct Effects of Vaping Questionnaire

    Time frame: Administered 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)

  2. Biphasic Alcohol Effects Scale

    Time frame: Conducted 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)

  3. General Labeled Magnitude Scale

    Time frame: Administered 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)

Sponsors and collaborators

Lead sponsor

Virginia Commonwealth University

Other

Collaborators

  • U.S. Department of Justice

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 1, 2019
Registry last updated
Apr 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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