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Completed

NCT Number: NCT04522973

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.

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Key information

Age range

21 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Beverage with ethanol and E-cigarette liquid with ethanol

Other

Beverage with ethanol and E-cigarette liquid with ethanol

Beverage with ethanol and E-cigarette liquid without ethanol

Other

Beverage with ethanol and E-cigarette liquid without ethanol

Beverage without ethanol and E-cigarette liquid with ethanol

Other

Beverage without ethanol and E-cigarette liquid with ethanol

Beverage without ethanol and E-cigarette liquid without ethanol

Other

Beverage without ethanol and E-cigarette liquid without ethanol

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

Secondary outcomes

  1. 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).

    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.
  2. 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).

    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
  3. 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).

    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

Other outcomes

  1. Subjective High Assessment Scale Questionnaire (SHAS)

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

    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.

  2. Biphasic Alcohol Effects Scale Questionnaire (BAES)

    Time frame: 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) 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.

  3. General Labeled Magnitude Scale Questionnaire (gLMS)

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

    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.

  4. Labeled Hedonic Scale Questionnaire (LHS)

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

    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

  5. Direct Effects of Vaping Questionnaire (DEPVQ)

    Time frame: 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 (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.

Sponsors and collaborators

Lead sponsor

Virginia Commonwealth University

Other

Collaborators

  • U.S. Department of Justice

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 21, 2020
Registry last updated
Jan 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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