Electronic Cigarette UseNCT04522973

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

A study testing Beverage with ethanol and E-cigarette liquid with ethanol, Beverage with ethanol and E-cigarette liquid without ethanol and Beverage without ethanol and E-cigarette liquid with ethanol in people with Electronic Cigarette Use, run by Virginia Commonwealth University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 21 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Electronic Cigarette Use
What is being tested?: Beverage with ethanol and E-cigarette liquid with ethanol, Beverage with ethanol and E-cigarette liquid without ethanol and Beverage without ethanol and E-cigarette liquid with ethanol
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: 1 siteUnited States
Study dates: 21 Apr 2023to 18 Jul 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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.

Who cannot join

Women who are breast-feeding or test positive for pregnancy (by urinalysis) at screening.

Trial locations and contacts

1 site in 1 country.

United States1 site

Virginia Commonwealth University
Richmond, Virginia, 23298

Other trials in United States

About this study

Conditions: Electronic Cigarette Use
Being tested: Beverage with ethanol and E-cigarette liquid with ethanol, Beverage with ethanol and E-cigarette liquid without ethanol, Beverage without ethanol and E-cigarette liquid with ethanol, Beverage without ethanol and E-cigarette liquid without ethanol
Medical subject headings: Vaping

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Beverage with ethanol and E-cigarette liquid with ethanolOther
Beverage with ethanol and E-cigarette liquid with ethanol
Beverage with ethanol and E-cigarette liquid without ethanolOther
Beverage with ethanol and E-cigarette liquid without ethanol
Beverage without ethanol and E-cigarette liquid with ethanolOther
Beverage without ethanol and E-cigarette liquid with ethanol
Beverage without ethanol and E-cigarette liquid without ethanolOther
Beverage without ethanol and E-cigarette liquid without ethanol

Study groups in NCT04522973
Study group	Role	What they receive
Within group four condition comparison	Other	Participants completed four ~5-hour, Latin-square ordered sessions separated by ≥48 hours. Session order was not recorded as it was not relevant to the study outcomes: Beverage with ethanol and E-cigarette liquid with ethanol, Beverage with ethanol and E-cigarette liquid without ethanol, Beverage without ethanol and E-cigarette liquid with ethanol, and Beverage without ethanol and E-cigarette liquid without ethanol. Receives: 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

What is being measured

The primary outcome is the main question the study is designed to answer.

Blood Alcohol Concentration
Blood alcohol concentration (BAC) level was determined 6 times over 6 hours to assess for changes in BAC from use of an e-cigarette containing ethanol compared to the use of an e-cigarette without ethanol.
Measured: Blood collected before (baseline) and after (0, 40, 55, 200, 215) drinking. The e-cigarette was used at 50 and 210 minutes post-drinking.
Breath Alcohol Concentration
Breath Alcohol Concentration (BrAC) was assessed 12 times over 6 hours to determine changes in BrAC from the use of an e-cigarette containing ethanol compared to the use of an e-cigarette without ethanol.
Measured: Breath was analyzed before (baseline) and after (10, 20, 40, 55, 90, 120, 165, 200, 215, 240, 270 min) drinking. The e-cigarette was used by the participants at 50 and 210 minutes post-drinking.
Oral Fluid Alcohol Concentration (OFAC)
Oral fluid alcohol concentration (OFAC) was assessed 9 times over 6 hours to determine changes in OFAC from the use of an e-cigarette containing ethanol compared to use of an e-cigarette without ethanol.
Measured: Oral fluid was collected before (baseline) and after (0, 5, 20, 40, 55, 200, 215, 240 min) drinking. The e-cigarette was used by the participants at 50 and 210 minutes post-drinking.
Ethanol Biomarker (5-Hydroxytryptophol) in Blood
5-Hydroxytryptophol was analyzed in blood 6 times over a course of 6 hours to assess changes in determined concentrations from use of an electronic cigarette containing ethanol.
Measured: Blood was collected before (baseline) and after (0, 40, 55, 200, 215 min) drinking. The e-cigarette was used by the participants at 50 and 210 minutes post-drinking.
Ethanol Biomarkers (5-Hydroxyindoleacetic Acid) in Blood
5-Hydroxyindoleacetic acid was analyzed in blood 6 times over a course of 6 hours to assess changes in determined concentrations from use of an electronic cigarette containing ethanol.
Measured: Blood was collected before (baseline) and after (0, 40, 55, 200, 215 min) drinking. The e-cigarette was used by the participants at 50 and 210 minutes post-drinking.
Ethanol Biomarkers (Ethyl Sulfate) Analyzed in Blood/ E-cig Containing Ethanol
Ethyl sulfate was analyzed in blood 6 times over a course of 6 hours to assess changes in determined concentrations from use of an electronic cigarette containing ethanol.
Measured: Blood was collected before (baseline) and after (0, 40, 55, 200, 215 min) drinking. The e-cigarette was used by the participants at 50 and 210 minutes post-drinking.
Ethanol Biomarkers (Phosphatidylethanol 16:0-18:1) in Blood
Phosphatidylethanol 16:0-18:1 was analyzed in blood 6 times over a course of 6 hours to assess changes in determined concentrations from use of an electronic cigarette containing ethanol.
Measured: Blood was collected before (baseline) and after (0, 40, 55, 200, 215 min) drinking. The e-cigarette was used by the participants at 50 and 210 minutes post-drinking.
Ethanol Biomarkers (Phosphatidylethanol 16:0-18:2) in Blood
Phosphatidylethanol 16:0-18:2 was analyzed in blood 6 times over a course of 6 hours to assess changes in determined concentrations from use of an electronic cigarette containing ethanol.
Measured: Blood was collected before (baseline) and after (0, 40, 55, 200, 215 min) drinking. The e-cigarette was used by the participants at 50 and 210 minutes post-drinking.
Ethanol Biomarkers (5-Hydroxytryptophol Glucuronide) Analyzed in Blood
5-Hydroxytryptophol glucuronide was analyzed in blood 6 times over a course of 6 hours to assess changes in determined concentrations from use of an electronic cigarette containing ethanol.
Measured: Blood collected before (baseline) and after (0, 40, 55, 200, 215 min) drinking. The e-cigarette was used by the participants at 50 and 210 minutes post-drinking.
Ethanol Biomarkers (5-Hydroxytryptophol) in Blood
Ethyl glucuronide was analyzed in blood 6 times over a course of 6 hours to assess changes in determined concentrations from use of an electronic cigarette containing ethanol.
Measured: Blood collected before (baseline) and after (0, 40, 55, 200, 215 min) drinking. The e-cigarette was used by the participants at 50 and 210 minutes post-drinking
Ethanol Biomarkers (5-Hydroxytryptophol) in Analyzed in Oral Fluid
5-Hydroxyindoleacetic acid was analyzed in oral fluid 9 times over a course of 6 hours to assess changes in determined concentrations from use of an electronic cigarette containing ethanol.
Measured: Oral fluid was collected before (baseline) and after (0, 5, 20, 40, 55, 200, 215, 240 min) drinking. The e-cigarette was used by the participants at 50 and 210 minutes post-drinking
Ethanol Biomarkers (5-Hydroxyindoleacetic Acid) Analyzed in Oral Fluid
5-Hydroxyindoleacetic acid was analyzed in oral fluid 9 times over a course of 6 hours to assess changes in determined concentrations from use of an electronic cigarette containing ethanol.
Measured: Oral fluid was collected before (baseline) and after (0, 5, 20, 40, 55, 200, 215, 240 min) drinking. The e-cigarette was used by the participants at 50 and 210 minutes post-drinking.
Ethanol Biomarkers (Ethyl Sulfate) Analyzed in Oral Fluid
Ethyl sulfate was analyzed in oral fluid 9 times over a course of 6 hours to assess changes in determined concentrations from use of an electronic cigarette containing ethanol.
Measured: Oral fluid was collected before (baseline) and after (0, 5, 20, 40, 55, 200, 215, 240 min) drinking. The e-cigarette was used by the participant at 50 and 210 minutes post-drinking
Ethanol Biomarkers (Phosphatidylethanol 16:0-18:1) Analyzed in Blood
Phosphatidylethanol 16:0-18:1 was analyzed in oral fluid 9 times over a course of 6 hours to assess changes in determined concentrations from use of an electronic cigarette containing ethanol.
Measured: Oral fluid was collected before (baseline) and after (0, 5, 20, 40, 55, 200, 215, 240 min) drinking. The e-cigarette was used by the participants at 50 and 210 minutes post-drinking.
Ethanol Biomarkers (Phosphatidylethanol 16:0-18:2) in Oral Fluid
Phosphatidylethanol 16:0-18:2 was analyzed in oral fluid 9 times over a course of 6 hours to assess changes in determined concentrations from use of an electronic cigarette containing ethanol.
Measured: Oral fluid was collected before (baseline) and after (0, 5, 20, 40, 55, 200, 215, 240 min) drinking. The e-cigarette was used by the participants at 50 and 210 minutes post-drinking.
Ethanol Biomarkers (Ethyl Glucuronide) Analyzed in Blood
Ethyl glucuronide was analyzed in blood 6 times over a course of 6 hours to assess changes in determined concentrations from use of an electronic cigarette containing ethanol.
Measured: Blood collected before (baseline) and after (0, 40, 55, 200, 215 min) drinking. The e-cigarette was used by the participant at 50 and 210 minutes post-drinking.
Ethanol Biomarkers (Ethyl Glucuronide) Analyzed in Oral Fluid
Ethyl glucuronide was analyzed in oral fluid 9 times over a course of 6 hours to assess changes in determined concentrations from use of an electronic cigarette containing ethanol.
Measured: Oral fluid was collected before (baseline) and after (0, 5, 20, 40, 55, 200, 215, 240 min) drinking. The e-cigarette was used by the participant at 50 and 210 minutes post-drinking

Secondary outcomes (3)

Horizontal Gaze Nystagmus
Standard Field Sobriety Tests (SFSTs) were administered 4 times over a course of 6 hours to assess changes in objective impairment. The SFST includes the Horizontal Gaze Nystagmus (a jerking or stuttering type of movement observed in a person's eyes that occurs as a result of consuming alcohol or other nervous system depressants) test. For each test, a law enforcement officer records the number of clues observed. HGN has a maximum of 6 clues, 3 per eye:
1. lack of smooth pursuit
2. distinct and sustained nystagmus at maximum deviation
3. onset of nystagmus prior to 45 degrees.
Measured: Conducted before drinking (baseline), at 20 minutes post-drinking (before first vaping bout), at 55 minutes post-drinking (after the first vaping), and at 215 minutes post-drinking (after second vaping bout).
Walk and Turn Test
Standard Field Sobriety Tests (SFSTs) were administered 4 times over a course of 6 hours to assess changes in objective impairment. The SFST includes the walk and turn test (suspect to perform a physical task while simultaneously following instructions and maintaining balance; involves walking a straight line heel-to-toe, turning, and walking back, with officers looking for specific indicators of impairment). For each test, a law enforcement officer records the number of clues observed. WAT has a maximum of 8 clues:
1. inability to balance during the instruction phase
2. starting before the officer has finished the instructions
3. Stopping while walking to regain balance
4. Not touching heel-to-toe
5. Stepping off the line
6. Using arms to balance
7. Losing balance on the turn or turning incorrectly
8. Taking the wrong number of steps
Measured: Conducted before drinking (baseline), at 20 minutes post-drinking (before first vaping bout), at 55 minutes post-drinking (after the first vaping), and at 215 minutes post-drinking (after second vaping bout).
One Leg Stand Test
Standard Field Sobriety Tests (SFSTs) were administered 4 times over a course of 6 hours to assess changes in objective impairment. The SFST includes the one-leg stand test (assess balance and coordination, potentially indicating impairment due to alcohol or drugs). For each test, a law enforcement officer records the number of clues observed. OLS has a maximum of 4 clues: Swaying while balancing, Using arms for balance, Hopping 4. Putting the raised foot down
Measured: Conducted before drinking (baseline), at 20 minutes post-drinking (before first vaping bout), at 55 minutes post-drinking (after the first vaping), and at 215 minutes post-drinking (after second vaping bout).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Apr 202318 Jul 2024

First posted21 Aug 2020
Study start21 Apr 2023
Primary completion18 Jul 2024
Study completion18 Jul 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Electronic Cigarette UseStudies of the same condition, open and under way.
More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Single group
Model description: Single group assignment
Masking: None (open label)
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04522973
Sponsor's protocol ID: HM20018402
Other IDs: 2019-MU-MU-0007
Status last verified: Dec 2025
First submitted: 13 Aug 2020
Last updated: 14 Jan 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Impact of Oral Ethanol and Vaped Ethanol on the Evaluation of Impairment
ClinicalTrials.gov ID: NCT04522973
Acronym / sponsor ID: HM20018402
Conditions: Electronic Cigarette Use
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: Virginia Commonwealth UniversityUniversity, hospital or other
Collaborators: U.S. Department of Justice
Study start: 21 Apr 2023 (actual)
Primary completion: 18 Jul 2024 (actual)
Study completion: 18 Jul 2024 (actual)
First posted: 21 Aug 2020 (actual)
Results: Posted 5 Nov 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Single group assignment

Arm	Type	Receives
Within group four condition comparison	Other	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 ethanolParticipants completed four ~5-hour, Latin-square ordered sessions separated by ≥48 hours. Session order was not recorded as it was not relevant to the study outcomes: Beverage with ethanol and E-cigarette liquid with ethanol, Beverage with ethanol and E-cigarette liquid without ethanol, Beverage without ethanol and E-cigarette liquid with ethanol, and Beverage without ethanol and E-cigarette liquid without ethanol.

Who may qualify

Ages: 21 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (1 listed)

Women who are breast-feeding or test positive for pregnancy (by urinalysis) at screening.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Beverage with ethanol and E-cigarette liquid with ethanolBeverage with ethanol and E-cigarette liquid with ethanol	Other	Within group four condition comparison
Beverage with ethanol and E-cigarette liquid without ethanolBeverage with ethanol and E-cigarette liquid without ethanol	Other	Within group four condition comparison
Beverage without ethanol and E-cigarette liquid with ethanolBeverage without ethanol and E-cigarette liquid with ethanol	Other	Within group four condition comparison
Beverage without ethanol and E-cigarette liquid without ethanolBeverage without ethanol and E-cigarette liquid without ethanol	Other	Within group four condition comparison

Primary outcome

Blood Alcohol Concentration
Time frame: Blood collected before (baseline) and after (0, 40, 55, 200, 215) drinking. The e-cigarette was used at 50 and 210 minutes post-drinking.
Blood alcohol concentration (BAC) level was determined 6 times over 6 hours to assess for changes in BAC from use of an e-cigarette containing ethanol compared to the use of an e-cigarette without ethanol.
Breath Alcohol Concentration
Time frame: Breath was analyzed before (baseline) and after (10, 20, 40, 55, 90, 120, 165, 200, 215, 240, 270 min) drinking. The e-cigarette was used by the participants at 50 and 210 minutes post-drinking.
Breath Alcohol Concentration (BrAC) was assessed 12 times over 6 hours to determine changes in BrAC from the use of an e-cigarette containing ethanol compared to the use of an e-cigarette without ethanol.
Oral Fluid Alcohol Concentration (OFAC)
Time frame: Oral fluid was collected before (baseline) and after (0, 5, 20, 40, 55, 200, 215, 240 min) drinking. The e-cigarette was used by the participants at 50 and 210 minutes post-drinking.
Oral fluid alcohol concentration (OFAC) was assessed 9 times over 6 hours to determine changes in OFAC from the use of an e-cigarette containing ethanol compared to use of an e-cigarette without ethanol.
Ethanol Biomarker (5-Hydroxytryptophol) in Blood
Time frame: Blood was collected before (baseline) and after (0, 40, 55, 200, 215 min) drinking. The e-cigarette was used by the participants at 50 and 210 minutes post-drinking.
5-Hydroxytryptophol was analyzed in blood 6 times over a course of 6 hours to assess changes in determined concentrations from use of an electronic cigarette containing ethanol.
Ethanol Biomarkers (5-Hydroxyindoleacetic Acid) in Blood
Time frame: Blood was collected before (baseline) and after (0, 40, 55, 200, 215 min) drinking. The e-cigarette was used by the participants at 50 and 210 minutes post-drinking.
5-Hydroxyindoleacetic acid was analyzed in blood 6 times over a course of 6 hours to assess changes in determined concentrations from use of an electronic cigarette containing ethanol.
Ethanol Biomarkers (Ethyl Sulfate) Analyzed in Blood/ E-cig Containing Ethanol
Time frame: Blood was collected before (baseline) and after (0, 40, 55, 200, 215 min) drinking. The e-cigarette was used by the participants at 50 and 210 minutes post-drinking.
Ethyl sulfate was analyzed in blood 6 times over a course of 6 hours to assess changes in determined concentrations from use of an electronic cigarette containing ethanol.
Ethanol Biomarkers (Phosphatidylethanol 16:0-18:1) in Blood
Time frame: Blood was collected before (baseline) and after (0, 40, 55, 200, 215 min) drinking. The e-cigarette was used by the participants at 50 and 210 minutes post-drinking.
Phosphatidylethanol 16:0-18:1 was analyzed in blood 6 times over a course of 6 hours to assess changes in determined concentrations from use of an electronic cigarette containing ethanol.
Ethanol Biomarkers (Phosphatidylethanol 16:0-18:2) in Blood
Time frame: Blood was collected before (baseline) and after (0, 40, 55, 200, 215 min) drinking. The e-cigarette was used by the participants at 50 and 210 minutes post-drinking.
Phosphatidylethanol 16:0-18:2 was analyzed in blood 6 times over a course of 6 hours to assess changes in determined concentrations from use of an electronic cigarette containing ethanol.
Ethanol Biomarkers (5-Hydroxytryptophol Glucuronide) Analyzed in Blood
Time frame: Blood collected before (baseline) and after (0, 40, 55, 200, 215 min) drinking. The e-cigarette was used by the participants at 50 and 210 minutes post-drinking.
5-Hydroxytryptophol glucuronide was analyzed in blood 6 times over a course of 6 hours to assess changes in determined concentrations from use of an electronic cigarette containing ethanol.
Ethanol Biomarkers (5-Hydroxytryptophol) in Blood
Time frame: Blood collected before (baseline) and after (0, 40, 55, 200, 215 min) drinking. The e-cigarette was used by the participants at 50 and 210 minutes post-drinking
Ethyl glucuronide was analyzed in blood 6 times over a course of 6 hours to assess changes in determined concentrations from use of an electronic cigarette containing ethanol.
Ethanol Biomarkers (5-Hydroxytryptophol) in Analyzed in Oral Fluid
Time frame: Oral fluid was collected before (baseline) and after (0, 5, 20, 40, 55, 200, 215, 240 min) drinking. The e-cigarette was used by the participants at 50 and 210 minutes post-drinking
5-Hydroxyindoleacetic acid was analyzed in oral fluid 9 times over a course of 6 hours to assess changes in determined concentrations from use of an electronic cigarette containing ethanol.
Ethanol Biomarkers (5-Hydroxyindoleacetic Acid) Analyzed in Oral Fluid
Time frame: Oral fluid was collected before (baseline) and after (0, 5, 20, 40, 55, 200, 215, 240 min) drinking. The e-cigarette was used by the participants at 50 and 210 minutes post-drinking.
5-Hydroxyindoleacetic acid was analyzed in oral fluid 9 times over a course of 6 hours to assess changes in determined concentrations from use of an electronic cigarette containing ethanol.
Ethanol Biomarkers (Ethyl Sulfate) Analyzed in Oral Fluid
Time frame: Oral fluid was collected before (baseline) and after (0, 5, 20, 40, 55, 200, 215, 240 min) drinking. The e-cigarette was used by the participant at 50 and 210 minutes post-drinking
Ethyl sulfate was analyzed in oral fluid 9 times over a course of 6 hours to assess changes in determined concentrations from use of an electronic cigarette containing ethanol.
Ethanol Biomarkers (Phosphatidylethanol 16:0-18:1) Analyzed in Blood
Time frame: Oral fluid was collected before (baseline) and after (0, 5, 20, 40, 55, 200, 215, 240 min) drinking. The e-cigarette was used by the participants at 50 and 210 minutes post-drinking.
Phosphatidylethanol 16:0-18:1 was analyzed in oral fluid 9 times over a course of 6 hours to assess changes in determined concentrations from use of an electronic cigarette containing ethanol.
Ethanol Biomarkers (Phosphatidylethanol 16:0-18:2) in Oral Fluid
Time frame: Oral fluid was collected before (baseline) and after (0, 5, 20, 40, 55, 200, 215, 240 min) drinking. The e-cigarette was used by the participants at 50 and 210 minutes post-drinking.
Phosphatidylethanol 16:0-18:2 was analyzed in oral fluid 9 times over a course of 6 hours to assess changes in determined concentrations from use of an electronic cigarette containing ethanol.
Ethanol Biomarkers (Ethyl Glucuronide) Analyzed in Blood
Time frame: Blood collected before (baseline) and after (0, 40, 55, 200, 215 min) drinking. The e-cigarette was used by the participant at 50 and 210 minutes post-drinking.
Ethyl glucuronide was analyzed in blood 6 times over a course of 6 hours to assess changes in determined concentrations from use of an electronic cigarette containing ethanol.
Ethanol Biomarkers (Ethyl Glucuronide) Analyzed in Oral Fluid
Time frame: Oral fluid was collected before (baseline) and after (0, 5, 20, 40, 55, 200, 215, 240 min) drinking. The e-cigarette was used by the participant at 50 and 210 minutes post-drinking
Ethyl glucuronide was analyzed in oral fluid 9 times over a course of 6 hours to assess changes in determined concentrations from use of an electronic cigarette containing ethanol.

3 secondary outcomes

Horizontal Gaze Nystagmus
Time frame: Conducted before drinking (baseline), at 20 minutes post-drinking (before first vaping bout), at 55 minutes post-drinking (after the first vaping), and at 215 minutes post-drinking (after second vaping bout).
Walk and Turn Test
Time frame: Conducted before drinking (baseline), at 20 minutes post-drinking (before first vaping bout), at 55 minutes post-drinking (after the first vaping), and at 215 minutes post-drinking (after second vaping bout).
One Leg Stand Test
Time frame: Conducted before drinking (baseline), at 20 minutes post-drinking (before first vaping bout), at 55 minutes post-drinking (after the first vaping), and at 215 minutes post-drinking (after second vaping bout).

Results and safety

Results posted to the registry on 5 Nov 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Within Group Four Condition Comparison	12	7

Primary outcome: Blood Alcohol Concentration

Time frame: Blood collected before (baseline) and after (0, 40, 55, 200, 215) drinking. The e-cigarette was used at 50 and 210 minutes post-drinking.. Mean (Standard Deviation). Unit: percent alcohol

Measure	Active Drink: Placebo Vape n = 7	Active Drink: Active Vape n = 7
Baseline Collection	0 (0)	0 (0)
0 Minute Collection Post-Drinking	.070 (.037)	.061 (.045)
40 Minute Collection Post-Drinking	.080 (.022)	.088 (.045)
55 Minute Collection Post-Drinking	.072 (.016)	.075 (.008)
200 Minute Collection Post-Drinking	.037 (.013)	.039 (.009)
210 Minute Collection Post-Drinking	.032 (.013)	.034 (.011)

Population analysed: Blood Alcohol Concentration (% alcohol)

Primary outcome: Breath Alcohol Concentration

Time frame: Breath was analyzed before (baseline) and after (10, 20, 40, 55, 90, 120, 165, 200, 215, 240, 270 min) drinking. The e-cigarette was used by the participants at 50 and 210 minutes post-drinking.. Mean (Standard Deviation). Unit: percent alcohol

Measure	Active Drink: Placebo Vape n = 7	Active Drink: Active Vape n = 7
Baseline	0 (0)	0 (0)
10 minute collection post-drinking	.069 (.024)	.080 (.0245)
20 minute collection post-drinking	.071 (.024)	.079 (.025)
40 minute collection post-drinking	.067 (.014)	.073 (.012)
55 minute collection post-drinking	.054 (.012)	.061 (.005)
90 minute collection post-drinking	.049 (.011)	.053 (.008)
120 minute collection post-drinking	.042 (.010)	.045 (.009)
165 minute collection post-drinking	.033 (.009)	.035 (.007)

Population analysed: Blood Alcohol Concentration (% alcohol)

Primary outcome: Oral Fluid Alcohol Concentration (OFAC)

Time frame: Oral fluid was collected before (baseline) and after (0, 5, 20, 40, 55, 200, 215, 240 min) drinking. The e-cigarette was used by the participants at 50 and 210 minutes post-drinking.. Mean (Standard Deviation). Unit: Percent Alcohol

Measure	Active Drink: Placebo Vape n = 7	Active Drink: Active Vape n = 7
Baseline Collection	0 (0)	0 (0)
0 minute collection post-drinking	.146 (.075)	.124 (.025)
5 minute collection post-drinking	.118 (.055)	.106 (.052)
20 minute collection post-drinking	.102 (.043)	.109 (.021)
40 minute collection post-drinking	.092 (.031)	.104 (.018)
55 minute collection post-drinking	.081 (.025)	.091 (.017)
200 minute collection post-drinking	.036 (.014)	.040 (.013)
215 minute collection post-drinking	.032 (.020)	.033 (.019)

Population analysed: Blood Alcohol Concentration (% alcohol)

Primary outcome: Ethanol Biomarker (5-Hydroxytryptophol) in Blood

Time frame: Blood was collected before (baseline) and after (0, 40, 55, 200, 215 min) drinking. The e-cigarette was used by the participants at 50 and 210 minutes post-drinking.. Mean (Standard Deviation). Unit: ng/mL

Measure	Placebo Drink: Placebo Vape n = 7	Placebo Drink: Active Vape n = 7	Active Drink: Placebo Vape n = 7	Active Drink: Active Vape n = 7
Baseline Collection	0 (0)	0 (0)	0 (0)	0 (0)
0 minute collection post-drinking	0 (0)	0 (0)	0 (0)	0 (0)
40 minute collection post-drinking	0 (0)	0 (0)	0 (0)	0 (0)
55 minute collection post-drinking	0 (0)	0 (0)	0 (0)	0 (0)
200 minute collection post-drinking	0 (0)	0 (0)	0 (0)	0 (0)
215 minute collection post-drinking	0 (0)	0 (0)	0 (0)	0 (0)

Population analysed: Ethanol Biomarker (5-Hydroxytryptophol) ng/mL

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: From baseline to session completion, approximately 7 hours for each session. On average, participants completed all 4 sessions within 1 month.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Within Group Four Condition Comparison	0 of 7 (0%)	2 of 7 (28.6%)	0 of 7

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Alison Breland, PhD principal investigator

Virginia Commonwealth University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Blood Alcohol Concentration (time frame: Blood collected before (baseline) and after (0, 40, 55, 200, 215) drinking. The e-cigarette was used at 50 and 210 minutes post-drinking.). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04522973.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2026.