The Impact of Vaping Ethanol in the Evaluation of Impairment

April 11, 2022 updated by: Virginia Commonwealth University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Virginia Commonwealth University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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)
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)
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)
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
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)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Administered after e-cigarette use (at 39 minutes after e-cigarette use)
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)
Conducted before and after the e-cigarette is used by the participant (change from baseline at 39 and 54 minutes after e-cigarette use)
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)
Administered after e-cigarette use (at 39 minutes after e-cigarette use)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Virginia Commonwealth University

Collaborators

U.S. Department of Justice

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 2, 2021

Primary Completion (ACTUAL)

April 8, 2022

Study Completion (ACTUAL)

April 8, 2022

Study Registration Dates

First Submitted

January 30, 2019

First Submitted That Met QC Criteria

January 30, 2019

First Posted (ACTUAL)

February 1, 2019

Study Record Updates

Last Update Posted (ACTUAL)

April 19, 2022

Last Update Submitted That Met QC Criteria

April 11, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HM20015064
  • 2018-75-CX-0036 (Other Grant/Funding Number: Department of Justice)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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