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

NCT04522973 | Completed Results

• 2 other identifiers: HM200184022019-MU-MU-0007
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Electronic Cigarette Use

Outcome Measures

Primary Outcomes (17)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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

  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

  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

  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).

Other Outcomes (5)

• Subjective High Assessment Scale Questionnaire (SHAS)

  Administered at baseline, 55 minutes post-drinking (after first vape bout), and 215 minutes post-drinking (after second vape bout).

• Biphasic Alcohol Effects Scale Questionnaire (BAES)

  Administered at baseline, 55 minutes post-drinking (after first vape bout), and 215 minutes post-drinking (after second vape bout).

• General Labeled Magnitude Scale Questionnaire (gLMS)

  Administered at baseline, 55 minutes post-drinking (after first vape bout), and 215 minutes post-drinking (after second vape bout).

Study Arms (1)

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.

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

Interventions

Beverage with ethanol and E-cigarette liquid without ethanol OTHER

Beverage with ethanol and E-cigarette liquid without ethanol

Within group four condition comparison

Beverage without ethanol and E-cigarette liquid with ethanol OTHER

Beverage without ethanol and E-cigarette liquid with ethanol

Within group four condition comparison

Beverage without ethanol and E-cigarette liquid without ethanol OTHER

Beverage without ethanol and E-cigarette liquid without ethanol

Within group four condition comparison

Beverage with ethanol and E-cigarette liquid with ethanol OTHER

Beverage with ethanol and E-cigarette liquid with ethanol

Within group four condition comparison

Eligibility Criteria

• Age: 21 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Virginia Commonwealth University: lead
• U.S. Department of Justice: collaborator

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Vaping

Interventions

Beverages; Ethanol

Condition Hierarchy (Ancestors)

Smoking; Behavior

Intervention Hierarchy (Ancestors)

Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Alcohols; Organic Chemicals

Results Point of Contact

• Title: Michelle Peace, PhD
• Organization: Virginia Commonwealth University

mrpeace@vcu.edu

804-828-8240

Study Officials

• Alison Breland, PhD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single group assignment

Study Record Dates

• First Submitted: August 13, 2020
• First Posted: August 21, 2020
• Study Start: April 21, 2023
• Primary Completion: July 18, 2024
• Study Completion: July 18, 2024
• Last Updated: January 14, 2026
• Results First Posted: November 5, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)