The Impact of Oral Ethanol and Vaped Ethanol on the Evaluation of Impairment

Study Overview
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Brief Summary
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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.

Official Title
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The Impact of Oral Ethanol and Vaped Ethanol on the Evaluation of Impairment

Conditions
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Electronic Cigarette Use

Intervention / Treatment
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* Other: Beverage with ethanol and E-cigarette liquid with ethanol
* Other: Beverage with ethanol and E-cigarette liquid without ethanol
* Other: Beverage without ethanol and E-cigarette liquid with ethanol
* Other: Beverage without ethanol and E-cigarette liquid without ethanol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: e-cigarette users willing to provide informed consent able to attend the lab sessions as needed agree to use designated products according to study protocol. Exclusion Criteria: Women who 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 stud

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Within group four condition comparison<br>On four separate occasions, participants will come to the research center and complete one of the four conditions. All participants will complete all four study conditions. Sessions will be ordered by Latin-square. Participants will not be assigned to arms based on session order and session order will not be recorded as it is not relevant to the study outcomes. | Other: Beverage with ethanol and E-cigarette liquid with ethanol<br>* Beverage with ethanol and E-cigarette liquid with ethanol<br>Other: Beverage with ethanol and E-cigarette liquid without ethanol<br>* Beverage with ethanol and E-cigarette liquid without ethanol<br>Other: Beverage without ethanol and E-cigarette liquid with ethanol<br>* Beverage without ethanol and E-cigarette liquid with ethanol<br>Other: Beverage without ethanol and E-cigarette liquid without ethanol<br>* Beverage without ethanol and E-cigarette liquid without ethanol<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in preliminary ethanol breath level | Preliminary ethanol breath level will be assessed using a probationary breath test or PBT, which involves blowing through a tube. | Conducted before and after the e-cigarette is used by the participant, at multiple time points (change from baseline reading at 45, 55, 125, 155, 200, 250, 280 minutes after e-cigarette use) | 
| Standard Field Sobriety Test | 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 55, 90, and 250 minutes after e-cigarette use) |