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The Impact of Vaping Ethanol in the Evaluation of Impairment

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ClinicalTrials.gov Identifier: NCT03826303
Recruitment Status : Recruiting
First Posted : February 1, 2019
Last Update Posted : April 20, 2021
Sponsor:
Collaborator:
U.S. Department of Justice
Information provided by (Responsible Party):
Virginia Commonwealth University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Electronic Cigarette Use Other: E-cigarette liquid with ethanol, 1 puff Other: E-cigarette liquid without ethanol, 1 puff Other: E-cigarette liquid with ethanol, 10 puffs Other: E-cigarette liquid without ethanol, 10 puffs Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: The Impact of Vaping Ethanol in the Evaluation of Impairment
Actual Study Start Date : April 2, 2021
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : July 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: E-Cigarettes
Drug Information available for: Ethanol

Arms and Interventions
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Arm Intervention/treatment
Experimental: E-cigarette with ethanol, 1 puff Other: E-cigarette liquid with ethanol, 1 puff
E-cigarette liquid with ethanol, 1 puff
Placebo Comparator: E-cigarette without ethanol, 1 puff Other: E-cigarette liquid without ethanol, 1 puff
E-cigarette liquid without ethanol, 1 puff
Experimental: E-cigarette with ethanol, 10 puffs Other: E-cigarette liquid with ethanol, 10 puffs
E-cigarette liquid with ethanol, 10 puffs
Placebo Comparator: E-cigarette without ethanol, 10 puffs Other: E-cigarette liquid without ethanol, 10 puffs
E-cigarette liquid without ethanol, 10 puffs


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures:
  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)


Eligibility Criteria
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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03826303


Contacts
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Contact: Alison Breland, PhD 8048273562 ctsp@vcu.edu
Contact: Barbara Kilgalen, RN 8048273562 ctsp@vcu.edu

Locations
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United States, Virginia
Virginia Commonwealth University Recruiting
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Virginia Commonwealth University
U.S. Department of Justice
Investigators
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Principal Investigator: Alison Breland, PhD Virginia Commonwealth University
More Information
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Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT03826303    
Other Study ID Numbers: HM20015064
2018-75-CX-0036 ( Other Grant/Funding Number: Department of Justice )
First Posted: February 1, 2019    Key Record Dates
Last Update Posted: April 20, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs