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

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.

Study Overview

• Status: Completed
• Conditions: Electronic Cigarette Use
• Intervention / Treatment: 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

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Richmond, Virginia, United States, 23298
      • Virginia Commonwealth University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Within group four condition comparison; 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; Beverage with ethanol and E-cigarette liquid with ethanol; Other: Beverage with ethanol and E-cigarette liquid without ethanol; Beverage with ethanol and E-cigarette liquid without ethanol; Other: Beverage without ethanol and E-cigarette liquid with ethanol; Beverage without ethanol and E-cigarette liquid with ethanol; Other: Beverage without ethanol and E-cigarette liquid without ethanol; Beverage without ethanol and E-cigarette liquid without ethanol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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: lack of smooth pursuit; distinct and sustained nystagmus at maximum deviation; onset of nystagmus prior to 45 degrees.	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: inability to balance during the instruction phase; starting before the officer has finished the instructions; Stopping while walking to regain balance; Not touching heel-to-toe; Stepping off the line; Using arms to balance; Losing balance on the turn or turning incorrectly; Taking the wrong number of steps	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	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective High Assessment Scale Questionnaire (SHAS)	Subjective High Assessment Scale Questionnaire (SHAS) is a 14-item questionnaire used to assess how intoxicated a person feels after consuming alcohol, typically administered in laboratory settings. It focuses on capturing subjective sensations associated with intoxication, such as feeling "clumsy," "dizzy," or "high". Participants rate their experience on a visual analog scale (a line with markings) to indicate the extent to which they feel each symptom at a given time. The scale ranges from Normal" (0) to "Extremely" (100). The score for each of the questions is summed to give an overall indication of the individual's subjective intoxication. A higher score would indicate greater feelings of impairment.	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)	Biphasic Alcohol Effects Scale Questionnaire (BAES) is a 14-item questionnaire consisting of adjectives that describe the stimulant- and sedative-like effects of alcohol. The items are presented in alphabetical order, and are rated on an 11-point rating scale from 0=Not at All to 10=Extremely. The score for each of the questions was summed to give an overall indication of the individual's subjective intoxication. A higher score would indicate greater feelings of impairment.	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)	The general labeled magnitude scale (gLMS) is a psychophysical scaling method used to measure the perceived intensity of various sensations. A gLMS typically ranges from 0 (undetectable) to 100 (strongest imaginable sensation/experience of any kind). Crucially, it uses specific labels positioned at specific points on the scale (e.g., barely detectable, weak, moderate, strong, very strong). The gLMS was comprised of 3 questions asking participants to indicate the overall flavor sensation, harshness, and throat hit of the e-cigarette. The score for each of the questions was summed. A higher score would indicate greater sensations from e-cigarette use.	Administered at baseline, 55 minutes post-drinking (after first vape bout), and 215 minutes post-drinking (after second vape bout).
Labeled Hedonic Scale Questionnaire (LHS)	A survey tool used to measure how much someone likes or dislikes something using descriptive labels for different levels of liking and disliking. Instead of just numbers, the scale uses words or phrases that describe the intensity of liking or disliking (e.g., "most disliked sensation imaginable"=0, "neutral" = 50, and "most liked sensation imaginable"=100) and aim to provide ratio-level data, meaning that the differences between scale points are meaningful and proportional. the LHS was comprised of 4 questions asking participants to indicate the e-cigarette's overall flavor sensation, harshness, throat hit, and warmth of the vapor. The score for each of the questions was summed. A higher score would indicate a more liked overall vaping experience; a lower score would indicate a more disliked overall vaping experience	Administered at baseline, 55 minutes post-drinking (after first vape bout), and 215 minutes post-drinking (after second vape bout).
Direct Effects of Vaping Questionnaire (DEPVQ)	Direct Effects of Vaping Questionnaire (DEVQ) is a 10-item Questionnaire that asks participants about their vaping experience (10 questions, each scored from 0 - 100). While subscale scores are often the primary focus, an overall score may be calculated by summing all item scores or averaging them. The score for each of the questions was summed. A higher score indicates the e-cigarette evoked greater subjective effects or feelings.	Administered at baseline, 55 minutes post-drinking (after first vape bout), and 215 minutes post-drinking (after second vape bout).

Collaborators and Investigators

• Sponsor: Virginia Commonwealth University
• Collaborators: U.S. Department of Justice
• Investigators: Principal Investigator: Alison Breland, PhD, Virginia Commonwealth University

Study record dates

Study Major Dates

• Study Start (Actual): April 21, 2023
• Primary Completion (Actual): July 18, 2024
• Study Completion (Actual): July 18, 2024

Study Registration Dates

• First Submitted: August 13, 2020
• First Submitted That Met QC Criteria: August 18, 2020
• First Posted (Actual): August 21, 2020

Study Record Updates

• Last Update Posted (Estimated): January 14, 2026
• Last Update Submitted That Met QC Criteria: December 19, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavior; Smoking; Vaping; Organic Chemicals; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Alcohols; Ethanol; Beverages
• Other Study ID Numbers: HM20018402; 2019-MU-MU-0007 (Other Grant/Funding Number: Department of Justice)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No