N/A
N=12
The Impact of Oral Ethanol and Vaped Ethanol on the Evaluation of Impairment
Electronic Cigarette Use
Bottom Line
View on ClinicalTrials.gov: NCT04522973 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Nov 2025
Primary outcome: Primary: Blood Alcohol Concentration — 0; 0; 0; 0 percent alcohol
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- 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 (Other)
- Age
- Adult · 21+ yrs
- Sex
- All
- Sponsor
- Virginia Commonwealth University
- Primary completion
- Jul 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Blood Alcohol Concentration |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Breath Alcohol Concentration |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Oral Fluid Alcohol Concentration (OFAC) |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Ethanol Biomarker (5-Hydroxytryptophol) in Blood |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Ethanol Biomarkers (5-Hydroxyindoleacetic Acid) in Blood |
80; 90; 44; 121; 91; 34 | — |
| PRIMARY Ethanol Biomarkers (Ethyl Sulfate) Analyzed in Blood/ E-cig Containing Ethanol |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Ethanol Biomarkers (Phosphatidylethanol 16:0-18:1) in Blood |
402; 416; 647; 409; 338; 304 | — |
| PRIMARY Ethanol Biomarkers (Phosphatidylethanol 16:0-18:2) in Blood |
894; 1013; 1256; 938; 549; 549 | — |
| PRIMARY Ethanol Biomarkers (5-Hydroxytryptophol Glucuronide) Analyzed in Blood |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Ethanol Biomarkers (5-Hydroxytryptophol) in Blood |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Ethanol Biomarkers (5-Hydroxytryptophol) in Analyzed in Oral Fluid |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Ethanol Biomarkers (5-Hydroxyindoleacetic Acid) Analyzed in Oral Fluid |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Ethanol Biomarkers (Ethyl Sulfate) Analyzed in Oral Fluid |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Ethanol Biomarkers (Phosphatidylethanol 16:0-18:1) Analyzed in Blood |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Ethanol Biomarkers (Phosphatidylethanol 16:0-18:2) in Oral Fluid |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Ethanol Biomarkers (Ethyl Glucuronide) Analyzed in Blood |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Ethanol Biomarkers (Ethyl Glucuronide) Analyzed in Oral Fluid |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Horizontal Gaze Nystagmus |
0; .9; .7; .3; .4; .9 | — |
| SECONDARY Walk and Turn Test |
.6; .9; .9; .6; .4; .9 | — |
| SECONDARY One Leg Stand Test |
.6; .7; .4; .7; .3; 0 | — |
Summary
The purpose of this research study is to determine if ethanol-containing e-cigarettes impact ethanol breath, blood or oral fluid tests, field sobriety tests, or other tests of sobriety. Ethanol is a common part of e-cigarette liquids.
Eligibility Criteria
Inclusion Criteria
- e-cigarette users
- alcohol consumers
- 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.
Data sourced from ClinicalTrials.gov (NCT04522973). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.