The Impact of Vaping Ethanol in 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 Vaping Ethanol in the Evaluation of Impairment

Conditions
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Electronic Cigarette Use

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 65 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
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: E-cigarette with ethanol, 1 puff<br> | Other: E-cigarette liquid with ethanol, 1 puff<br>* E-cigarette liquid with ethanol, 1 puff<br>|
| Placebo Comparator: E-cigarette without ethanol, 1 puff<br> | Other: E-cigarette liquid without ethanol, 1 puff<br>* E-cigarette liquid without ethanol, 1 puff<br>|
| Experimental: E-cigarette with ethanol, 10 puffs<br> | Other: E-cigarette liquid with ethanol, 10 puffs<br>* E-cigarette liquid with ethanol, 10 puffs<br>|
| Placebo Comparator: E-cigarette without ethanol, 10 puffs<br> | Other: E-cigarette liquid without ethanol, 10 puffs<br>* E-cigarette liquid without ethanol, 10 puffs<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preliminary breath test for ethanol | 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 | 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 | 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) |