Trial Outcomes & Findings for The Impact of Oral Ethanol and Vaped Ethanol on the Evaluation of Impairment (NCT NCT04522973)
NCT ID: NCT04522973
Last Updated: 2026-01-14
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
12 participants
Primary outcome timeframe
Blood collected before (baseline) and after (0, 40, 55, 200, 215) drinking. The e-cigarette was used at 50 and 210 minutes post-drinking.
Results posted on
2026-01-14
Participant Flow
Participant milestones
| Measure |
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. Session interventions were as follows:
* Placebo drink: Placebo vape (Beverage without ethanol and E-cigarette liquid without ethanol)
* Placebo drink: Active vape (Beverage without ethanol and E-cigarette liquid with 20% ethanol)
* Active drink: Placebo vape (Beverage with 50% ethanol (dosed to have the participant reach a 0.08% BAC) and E-cigarette liquid without ethanol)
* Active drink: Active vape (Beverage with 50% ethanol (dosed to have the participant reach a 0.08% BAC) and E-cigarette liquid with 20% ethanol)
|
|---|---|
|
Overall Study
STARTED
|
12
|
|
Overall Study
COMPLETED
|
7
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
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. Session interventions were as follows:
* Placebo drink: Placebo vape (Beverage without ethanol and E-cigarette liquid without ethanol)
* Placebo drink: Active vape (Beverage without ethanol and E-cigarette liquid with 20% ethanol)
* Active drink: Placebo vape (Beverage with 50% ethanol (dosed to have the participant reach a 0.08% BAC) and E-cigarette liquid without ethanol)
* Active drink: Active vape (Beverage with 50% ethanol (dosed to have the participant reach a 0.08% BAC) and E-cigarette liquid with 20% ethanol)
|
|---|---|
|
Overall Study
Lost to Follow-up
|
4
|
|
Overall Study
Could not adhere to study schedule
|
1
|
Baseline Characteristics
The Impact of Oral Ethanol and Vaped Ethanol on the Evaluation of Impairment
Baseline characteristics by cohort
| Measure |
Within Group Four Condition Comparison
n=7 Participants
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. Session interventions were as follows:
* Placebo drink: Placebo vape (Beverage without ethanol and E-cigarette liquid without ethanol)
* Placebo drink: Active vape (Beverage without ethanol and E-cigarette liquid with 20% ethanol)
* Active drink: Placebo vape (Beverage with 50% ethanol (dosed to have the participant reach a 0.08% BAC) and E-cigarette liquid without ethanol)
* Active drink: Active vape (Beverage with 50% ethanol (dosed to have the participant reach a 0.08% BAC) and E-cigarette liquid with 20% ethanol)
|
|---|---|
|
Age, Continuous
|
24.6 years
STANDARD_DEVIATION 3.5 • n=14 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=14 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=14 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=14 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=14 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=14 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=14 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=14 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=14 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=14 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=14 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=14 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=14 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=14 Participants
|
PRIMARY outcome
Timeframe: Blood collected before (baseline) and after (0, 40, 55, 200, 215) drinking. The e-cigarette was used at 50 and 210 minutes post-drinking.Population: Blood Alcohol Concentration (% alcohol)
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.
Outcome measures
| Measure |
Active Drink: Placebo Vape
n=7 Participants
Beverage with 50% ethanol (dosed to have the participant reach a 0.08% BAC) and E-cigarette liquid without ethanol
|
Active Drink: Active Vape
n=7 Participants
Beverage with 50% ethanol (dosed to have the participant reach a 0.08% BAC) and E-cigarette liquid with 20% ethanol
|
Placebo Drink: Placebo Vape
n=7 Participants
Beverage without ethanol and E-cigarette liquid without ethanol
|
Placebo Drink: Active Vape
n=7 Participants
Beverage without ethanol and E-cigarette liquid with 20% ethanol
|
|---|---|---|---|---|
|
Blood Alcohol Concentration
200 Minute Collection Post-Drinking
|
.037 percent alcohol
Standard Deviation .013
|
.039 percent alcohol
Standard Deviation .009
|
0 percent alcohol
Standard Deviation 0
|
0 percent alcohol
Standard Deviation 0
|
|
Blood Alcohol Concentration
210 Minute Collection Post-Drinking
|
.032 percent alcohol
Standard Deviation .013
|
.034 percent alcohol
Standard Deviation .011
|
0 percent alcohol
Standard Deviation 0
|
0 percent alcohol
Standard Deviation 0
|
|
Blood Alcohol Concentration
Baseline Collection
|
0 percent alcohol
Standard Deviation 0
|
0 percent alcohol
Standard Deviation 0
|
0 percent alcohol
Standard Deviation 0
|
0 percent alcohol
Standard Deviation 0
|
|
Blood Alcohol Concentration
0 Minute Collection Post-Drinking
|
.070 percent alcohol
Standard Deviation .037
|
.061 percent alcohol
Standard Deviation .045
|
0 percent alcohol
Standard Deviation 0
|
0 percent alcohol
Standard Deviation 0
|
|
Blood Alcohol Concentration
40 Minute Collection Post-Drinking
|
.080 percent alcohol
Standard Deviation .022
|
.088 percent alcohol
Standard Deviation .045
|
0 percent alcohol
Standard Deviation 0
|
0 percent alcohol
Standard Deviation 0
|
|
Blood Alcohol Concentration
55 Minute Collection Post-Drinking
|
.072 percent alcohol
Standard Deviation .016
|
.075 percent alcohol
Standard Deviation .008
|
0 percent alcohol
Standard Deviation 0
|
0 percent alcohol
Standard Deviation 0
|
PRIMARY outcome
Timeframe: 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.Population: Blood Alcohol Concentration (% alcohol)
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.
Outcome measures
| Measure |
Active Drink: Placebo Vape
n=7 Participants
Beverage with 50% ethanol (dosed to have the participant reach a 0.08% BAC) and E-cigarette liquid without ethanol
|
Active Drink: Active Vape
n=7 Participants
Beverage with 50% ethanol (dosed to have the participant reach a 0.08% BAC) and E-cigarette liquid with 20% ethanol
|
Placebo Drink: Placebo Vape
n=7 Participants
Beverage without ethanol and E-cigarette liquid without ethanol
|
Placebo Drink: Active Vape
n=7 Participants
Beverage without ethanol and E-cigarette liquid with 20% ethanol
|
|---|---|---|---|---|
|
Breath Alcohol Concentration
90 minute collection post-drinking
|
.049 percent alcohol
Standard Deviation .011
|
.053 percent alcohol
Standard Deviation .008
|
0 percent alcohol
Standard Deviation 0
|
0 percent alcohol
Standard Deviation 0
|
|
Breath Alcohol Concentration
120 minute collection post-drinking
|
.042 percent alcohol
Standard Deviation .010
|
.045 percent alcohol
Standard Deviation .009
|
0 percent alcohol
Standard Deviation 0
|
0 percent alcohol
Standard Deviation 0
|
|
Breath Alcohol Concentration
165 minute collection post-drinking
|
.033 percent alcohol
Standard Deviation .009
|
.035 percent alcohol
Standard Deviation .007
|
0 percent alcohol
Standard Deviation 0
|
0 percent alcohol
Standard Deviation 0
|
|
Breath Alcohol Concentration
200 minute collection post-drinking
|
.026 percent alcohol
Standard Deviation .009
|
.027 percent alcohol
Standard Deviation .008
|
0 percent alcohol
Standard Deviation 0
|
0 percent alcohol
Standard Deviation 0
|
|
Breath Alcohol Concentration
215 minute collection post-drinking
|
.018 percent alcohol
Standard Deviation .006
|
.024 percent alcohol
Standard Deviation .005
|
0 percent alcohol
Standard Deviation 0
|
0 percent alcohol
Standard Deviation 0
|
|
Breath Alcohol Concentration
240 minute collection post-drinking
|
.016 percent alcohol
Standard Deviation .010
|
.016 percent alcohol
Standard Deviation 011
|
0 percent alcohol
Standard Deviation 0
|
0 percent alcohol
Standard Deviation 0
|
|
Breath Alcohol Concentration
270 minute collection post-drinking
|
.009 percent alcohol
Standard Deviation .009
|
.011 percent alcohol
Standard Deviation .009
|
0 percent alcohol
Standard Deviation 0
|
0 percent alcohol
Standard Deviation 0
|
|
Breath Alcohol Concentration
10 minute collection post-drinking
|
.069 percent alcohol
Standard Deviation .024
|
.080 percent alcohol
Standard Deviation .0245
|
0 percent alcohol
Standard Deviation 0
|
0 percent alcohol
Standard Deviation 0
|
|
Breath Alcohol Concentration
20 minute collection post-drinking
|
.071 percent alcohol
Standard Deviation .024
|
.079 percent alcohol
Standard Deviation .025
|
0 percent alcohol
Standard Deviation 0
|
0 percent alcohol
Standard Deviation 0
|
|
Breath Alcohol Concentration
40 minute collection post-drinking
|
.067 percent alcohol
Standard Deviation .014
|
.073 percent alcohol
Standard Deviation .012
|
0 percent alcohol
Standard Deviation 0
|
0 percent alcohol
Standard Deviation 0
|
|
Breath Alcohol Concentration
55 minute collection post-drinking
|
.054 percent alcohol
Standard Deviation .012
|
.061 percent alcohol
Standard Deviation .005
|
0 percent alcohol
Standard Deviation 0
|
0 percent alcohol
Standard Deviation 0
|
|
Breath Alcohol Concentration
Baseline
|
0 percent alcohol
Standard Deviation 0
|
0 percent alcohol
Standard Deviation 0
|
0 percent alcohol
Standard Deviation 0
|
0 percent alcohol
Standard Deviation 0
|
PRIMARY outcome
Timeframe: 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.Population: Blood Alcohol Concentration (% alcohol)
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.
Outcome measures
| Measure |
Active Drink: Placebo Vape
n=7 Participants
Beverage with 50% ethanol (dosed to have the participant reach a 0.08% BAC) and E-cigarette liquid without ethanol
|
Active Drink: Active Vape
n=7 Participants
Beverage with 50% ethanol (dosed to have the participant reach a 0.08% BAC) and E-cigarette liquid with 20% ethanol
|
Placebo Drink: Placebo Vape
n=7 Participants
Beverage without ethanol and E-cigarette liquid without ethanol
|
Placebo Drink: Active Vape
n=7 Participants
Beverage without ethanol and E-cigarette liquid with 20% ethanol
|
|---|---|---|---|---|
|
Oral Fluid Alcohol Concentration (OFAC)
Baseline Collection
|
0 Percent Alcohol
Standard Deviation 0
|
0 Percent Alcohol
Standard Deviation 0
|
0 Percent Alcohol
Standard Deviation 0
|
0 Percent Alcohol
Standard Deviation 0
|
|
Oral Fluid Alcohol Concentration (OFAC)
0 minute collection post-drinking
|
.146 Percent Alcohol
Standard Deviation .075
|
.124 Percent Alcohol
Standard Deviation .025
|
0 Percent Alcohol
Standard Deviation 0
|
0 Percent Alcohol
Standard Deviation 0
|
|
Oral Fluid Alcohol Concentration (OFAC)
5 minute collection post-drinking
|
.118 Percent Alcohol
Standard Deviation .055
|
.106 Percent Alcohol
Standard Deviation .052
|
0 Percent Alcohol
Standard Deviation 0
|
0 Percent Alcohol
Standard Deviation 0
|
|
Oral Fluid Alcohol Concentration (OFAC)
20 minute collection post-drinking
|
.102 Percent Alcohol
Standard Deviation .043
|
.109 Percent Alcohol
Standard Deviation .021
|
0 Percent Alcohol
Standard Deviation 0
|
0 Percent Alcohol
Standard Deviation 0
|
|
Oral Fluid Alcohol Concentration (OFAC)
40 minute collection post-drinking
|
.092 Percent Alcohol
Standard Deviation .031
|
.104 Percent Alcohol
Standard Deviation .018
|
0 Percent Alcohol
Standard Deviation 0
|
0 Percent Alcohol
Standard Deviation 0
|
|
Oral Fluid Alcohol Concentration (OFAC)
55 minute collection post-drinking
|
.081 Percent Alcohol
Standard Deviation .025
|
.091 Percent Alcohol
Standard Deviation .017
|
0 Percent Alcohol
Standard Deviation 0
|
0 Percent Alcohol
Standard Deviation 0
|
|
Oral Fluid Alcohol Concentration (OFAC)
200 minute collection post-drinking
|
.036 Percent Alcohol
Standard Deviation .014
|
.040 Percent Alcohol
Standard Deviation .013
|
0 Percent Alcohol
Standard Deviation 0
|
0 Percent Alcohol
Standard Deviation 0
|
|
Oral Fluid Alcohol Concentration (OFAC)
215 minute collection post-drinking
|
.032 Percent Alcohol
Standard Deviation .020
|
.033 Percent Alcohol
Standard Deviation .019
|
0 Percent Alcohol
Standard Deviation 0
|
0 Percent Alcohol
Standard Deviation 0
|
|
Oral Fluid Alcohol Concentration (OFAC)
240 minute collection post-drinking
|
.023 Percent Alcohol
Standard Deviation .019
|
.023 Percent Alcohol
Standard Deviation .018
|
0 Percent Alcohol
Standard Deviation 0
|
0 Percent Alcohol
Standard Deviation 0
|
PRIMARY outcome
Timeframe: 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.Population: Ethanol Biomarker (5-Hydroxytryptophol) ng/mL
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.
Outcome measures
| Measure |
Active Drink: Placebo Vape
n=7 Participants
Beverage with 50% ethanol (dosed to have the participant reach a 0.08% BAC) and E-cigarette liquid without ethanol
|
Active Drink: Active Vape
n=7 Participants
Beverage with 50% ethanol (dosed to have the participant reach a 0.08% BAC) and E-cigarette liquid with 20% ethanol
|
Placebo Drink: Placebo Vape
n=7 Participants
Beverage without ethanol and E-cigarette liquid without ethanol
|
Placebo Drink: Active Vape
n=7 Participants
Beverage without ethanol and E-cigarette liquid with 20% ethanol
|
|---|---|---|---|---|
|
Ethanol Biomarker (5-Hydroxytryptophol) in Blood
Baseline Collection
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
|
Ethanol Biomarker (5-Hydroxytryptophol) in Blood
0 minute collection post-drinking
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
|
Ethanol Biomarker (5-Hydroxytryptophol) in Blood
40 minute collection post-drinking
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
|
Ethanol Biomarker (5-Hydroxytryptophol) in Blood
55 minute collection post-drinking
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
|
Ethanol Biomarker (5-Hydroxytryptophol) in Blood
200 minute collection post-drinking
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
|
Ethanol Biomarker (5-Hydroxytryptophol) in Blood
215 minute collection post-drinking
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
PRIMARY outcome
Timeframe: 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.Population: Ethanol Biomarkers (5-Hydroxyindoleacetic Acid) ng/mL
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.
Outcome measures
| Measure |
Active Drink: Placebo Vape
n=7 Participants
Beverage with 50% ethanol (dosed to have the participant reach a 0.08% BAC) and E-cigarette liquid without ethanol
|
Active Drink: Active Vape
n=7 Participants
Beverage with 50% ethanol (dosed to have the participant reach a 0.08% BAC) and E-cigarette liquid with 20% ethanol
|
Placebo Drink: Placebo Vape
n=7 Participants
Beverage without ethanol and E-cigarette liquid without ethanol
|
Placebo Drink: Active Vape
n=7 Participants
Beverage without ethanol and E-cigarette liquid with 20% ethanol
|
|---|---|---|---|---|
|
Ethanol Biomarkers (5-Hydroxyindoleacetic Acid) in Blood
Baseline Collection
|
44 ng/mL
Standard Deviation 75
|
121 ng/mL
Standard Deviation 149
|
80 ng/mL
Standard Deviation 81
|
90 ng/mL
Standard Deviation 91
|
|
Ethanol Biomarkers (5-Hydroxyindoleacetic Acid) in Blood
0 minute collection post-drinking
|
44 ng/mL
Standard Deviation 29
|
76 ng/mL
Standard Deviation 36
|
91 ng/mL
Standard Deviation 97
|
34 ng/mL
Standard Deviation 59
|
|
Ethanol Biomarkers (5-Hydroxyindoleacetic Acid) in Blood
40 minute collection post-drinking
|
30 ng/mL
Standard Deviation 51
|
63 ng/mL
Standard Deviation 81
|
97 ng/mL
Standard Deviation 96
|
93 ng/mL
Standard Deviation 93
|
|
Ethanol Biomarkers (5-Hydroxyindoleacetic Acid) in Blood
55 minute collection post-drinking
|
61 ng/mL
Standard Deviation 80
|
0 ng/mL
Standard Deviation 0
|
103 ng/mL
Standard Deviation 103
|
75 ng/mL
Standard Deviation 99
|
|
Ethanol Biomarkers (5-Hydroxyindoleacetic Acid) in Blood
200 minute collection post-drinking
|
71 ng/mL
Standard Deviation 94
|
90 ng/mL
Standard Deviation 86
|
123 ng/mL
Standard Deviation 98
|
132 ng/mL
Standard Deviation 103
|
|
Ethanol Biomarkers (5-Hydroxyindoleacetic Acid) in Blood
215 minute collection post-drinking
|
73 ng/mL
Standard Deviation 97
|
83 ng/mL
Standard Deviation 114
|
82 ng/mL
Standard Deviation 81
|
106 ng/mL
Standard Deviation 79
|
PRIMARY outcome
Timeframe: 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.Population: Ethanol Biomarkers (Ethyl Sulfate) ng/mL
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.
Outcome measures
| Measure |
Active Drink: Placebo Vape
n=7 Participants
Beverage with 50% ethanol (dosed to have the participant reach a 0.08% BAC) and E-cigarette liquid without ethanol
|
Active Drink: Active Vape
n=7 Participants
Beverage with 50% ethanol (dosed to have the participant reach a 0.08% BAC) and E-cigarette liquid with 20% ethanol
|
Placebo Drink: Placebo Vape
n=7 Participants
Beverage without ethanol and E-cigarette liquid without ethanol
|
Placebo Drink: Active Vape
n=7 Participants
Beverage without ethanol and E-cigarette liquid with 20% ethanol
|
|---|---|---|---|---|
|
Ethanol Biomarkers (Ethyl Sulfate) Analyzed in Blood/ E-cig Containing Ethanol
Baseline Collection
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
|
Ethanol Biomarkers (Ethyl Sulfate) Analyzed in Blood/ E-cig Containing Ethanol
0 minute collection post-drinking
|
16 ng/mL
Standard Deviation 28
|
10 ng/mL
Standard Deviation 26
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
|
Ethanol Biomarkers (Ethyl Sulfate) Analyzed in Blood/ E-cig Containing Ethanol
40 minute collection post-drinking
|
167 ng/mL
Standard Deviation 80
|
184 ng/mL
Standard Deviation 52
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
|
Ethanol Biomarkers (Ethyl Sulfate) Analyzed in Blood/ E-cig Containing Ethanol
55 minute collection post-drinking
|
207 ng/mL
Standard Deviation 67
|
211 ng/mL
Standard Deviation 46
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
|
Ethanol Biomarkers (Ethyl Sulfate) Analyzed in Blood/ E-cig Containing Ethanol
200 minute collection post-drinking
|
228 ng/mL
Standard Deviation 68
|
239 ng/mL
Standard Deviation 55
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
|
Ethanol Biomarkers (Ethyl Sulfate) Analyzed in Blood/ E-cig Containing Ethanol
215 minute collection post-drinking
|
218 ng/mL
Standard Deviation 67
|
224 ng/mL
Standard Deviation 50
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
PRIMARY outcome
Timeframe: 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.Population: Ethanol Biomarkers (Phosphatidylethanol 16:0-18:1) in Blood ng/mL
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.
Outcome measures
| Measure |
Active Drink: Placebo Vape
n=7 Participants
Beverage with 50% ethanol (dosed to have the participant reach a 0.08% BAC) and E-cigarette liquid without ethanol
|
Active Drink: Active Vape
n=7 Participants
Beverage with 50% ethanol (dosed to have the participant reach a 0.08% BAC) and E-cigarette liquid with 20% ethanol
|
Placebo Drink: Placebo Vape
n=7 Participants
Beverage without ethanol and E-cigarette liquid without ethanol
|
Placebo Drink: Active Vape
n=7 Participants
Beverage without ethanol and E-cigarette liquid with 20% ethanol
|
|---|---|---|---|---|
|
Ethanol Biomarkers (Phosphatidylethanol 16:0-18:1) in Blood
Baseline Collection
|
647 ng/mL
Standard Deviation 790
|
409 ng/mL
Standard Deviation 323
|
402 ng/mL
Standard Deviation 438
|
416 ng/mL
Standard Deviation 432
|
|
Ethanol Biomarkers (Phosphatidylethanol 16:0-18:1) in Blood
0 minute collection post-drinking
|
487 ng/mL
Standard Deviation 570
|
318 ng/mL
Standard Deviation 269
|
338 ng/mL
Standard Deviation 443
|
304 ng/mL
Standard Deviation 433
|
|
Ethanol Biomarkers (Phosphatidylethanol 16:0-18:1) in Blood
40 minute collection post-drinking
|
562 ng/mL
Standard Deviation 688
|
306 ng/mL
Standard Deviation 270
|
345 ng/mL
Standard Deviation 460
|
322 ng/mL
Standard Deviation 442
|
|
Ethanol Biomarkers (Phosphatidylethanol 16:0-18:1) in Blood
55 minute collection post-drinking
|
589 ng/mL
Standard Deviation 699
|
374 ng/mL
Standard Deviation 284
|
330 ng/mL
Standard Deviation 401
|
292 ng/mL
Standard Deviation 339
|
|
Ethanol Biomarkers (Phosphatidylethanol 16:0-18:1) in Blood
200 minute collection post-drinking
|
547 ng/mL
Standard Deviation 722
|
319 ng/mL
Standard Deviation 297
|
352 ng/mL
Standard Deviation 489
|
302 ng/mL
Standard Deviation 353
|
|
Ethanol Biomarkers (Phosphatidylethanol 16:0-18:1) in Blood
215 minute collection post-drinking
|
718 ng/mL
Standard Deviation 744
|
450 ng/mL
Standard Deviation 239
|
639 ng/mL
Standard Deviation 739
|
411 ng/mL
Standard Deviation 397
|
PRIMARY outcome
Timeframe: 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.Population: Ethanol Biomarkers (Phosphatidylethanol 16:0-18:2) in Blood ng/mL
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.
Outcome measures
| Measure |
Active Drink: Placebo Vape
n=7 Participants
Beverage with 50% ethanol (dosed to have the participant reach a 0.08% BAC) and E-cigarette liquid without ethanol
|
Active Drink: Active Vape
n=7 Participants
Beverage with 50% ethanol (dosed to have the participant reach a 0.08% BAC) and E-cigarette liquid with 20% ethanol
|
Placebo Drink: Placebo Vape
n=7 Participants
Beverage without ethanol and E-cigarette liquid without ethanol
|
Placebo Drink: Active Vape
n=7 Participants
Beverage without ethanol and E-cigarette liquid with 20% ethanol
|
|---|---|---|---|---|
|
Ethanol Biomarkers (Phosphatidylethanol 16:0-18:2) in Blood
Baseline Collection
|
1256 ng/mL
Standard Deviation 1756
|
938 ng/mL
Standard Deviation 784
|
894 ng/mL
Standard Deviation 956
|
1013 ng/mL
Standard Deviation 1403
|
|
Ethanol Biomarkers (Phosphatidylethanol 16:0-18:2) in Blood
0 minute collection post-drinking
|
771 ng/mL
Standard Deviation 939
|
616 ng/mL
Standard Deviation 577
|
549 ng/mL
Standard Deviation 757
|
549 ng/mL
Standard Deviation 894
|
|
Ethanol Biomarkers (Phosphatidylethanol 16:0-18:2) in Blood
40 minute collection post-drinking
|
927 ng/mL
Standard Deviation 1214
|
617 ng/mL
Standard Deviation 589
|
563 ng/mL
Standard Deviation 806
|
572 ng/mL
Standard Deviation 768
|
|
Ethanol Biomarkers (Phosphatidylethanol 16:0-18:2) in Blood
55 minute collection post-drinking
|
862 ng/mL
Standard Deviation 1061
|
832 ng/mL
Standard Deviation 587
|
574 ng/mL
Standard Deviation 758
|
466 ng/mL
Standard Deviation 580
|
|
Ethanol Biomarkers (Phosphatidylethanol 16:0-18:2) in Blood
200 minute collection post-drinking
|
1028 ng/mL
Standard Deviation 1479
|
602 ng/mL
Standard Deviation 500
|
636 ng/mL
Standard Deviation 1000
|
494 ng/mL
Standard Deviation 685
|
|
Ethanol Biomarkers (Phosphatidylethanol 16:0-18:2) in Blood
215 minute collection post-drinking
|
1544 ng/mL
Standard Deviation 1417
|
1081 ng/mL
Standard Deviation 480
|
1630 ng/mL
Standard Deviation 2090
|
889 ng/mL
Standard Deviation 873
|
PRIMARY outcome
Timeframe: 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.Population: Ethanol Biomarkers (5-Hydroxytryptophol Glucuronide) in Blood ng/mL
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.
Outcome measures
| Measure |
Active Drink: Placebo Vape
n=7 Participants
Beverage with 50% ethanol (dosed to have the participant reach a 0.08% BAC) and E-cigarette liquid without ethanol
|
Active Drink: Active Vape
n=7 Participants
Beverage with 50% ethanol (dosed to have the participant reach a 0.08% BAC) and E-cigarette liquid with 20% ethanol
|
Placebo Drink: Placebo Vape
n=7 Participants
Beverage without ethanol and E-cigarette liquid without ethanol
|
Placebo Drink: Active Vape
n=7 Participants
Beverage without ethanol and E-cigarette liquid with 20% ethanol
|
|---|---|---|---|---|
|
Ethanol Biomarkers (5-Hydroxytryptophol Glucuronide) Analyzed in Blood
Baseline collection
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
|
Ethanol Biomarkers (5-Hydroxytryptophol Glucuronide) Analyzed in Blood
0 minute collection post-drinking
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
|
Ethanol Biomarkers (5-Hydroxytryptophol Glucuronide) Analyzed in Blood
40 minute collection post-drinking
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
|
Ethanol Biomarkers (5-Hydroxytryptophol Glucuronide) Analyzed in Blood
55 minute collection post-drinking
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
|
Ethanol Biomarkers (5-Hydroxytryptophol Glucuronide) Analyzed in Blood
200 minute collection post-drinking
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
|
Ethanol Biomarkers (5-Hydroxytryptophol Glucuronide) Analyzed in Blood
215 minute collection post-drinking
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
PRIMARY outcome
Timeframe: 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-drinkingPopulation: Ethanol Biomarkers (Ethyl Glucuronide ) in Blood ng/mL
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.
Outcome measures
| Measure |
Active Drink: Placebo Vape
n=7 Participants
Beverage with 50% ethanol (dosed to have the participant reach a 0.08% BAC) and E-cigarette liquid without ethanol
|
Active Drink: Active Vape
n=7 Participants
Beverage with 50% ethanol (dosed to have the participant reach a 0.08% BAC) and E-cigarette liquid with 20% ethanol
|
Placebo Drink: Placebo Vape
n=7 Participants
Beverage without ethanol and E-cigarette liquid without ethanol
|
Placebo Drink: Active Vape
n=7 Participants
Beverage without ethanol and E-cigarette liquid with 20% ethanol
|
|---|---|---|---|---|
|
Ethanol Biomarkers (5-Hydroxytryptophol) in Blood
Baseline
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
|
Ethanol Biomarkers (5-Hydroxytryptophol) in Blood
0 minute collection post-drinking
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
|
Ethanol Biomarkers (5-Hydroxytryptophol) in Blood
40 minute collection post-drinking
|
145 ng/mL
Standard Deviation 53
|
128 ng/mL
Standard Deviation 29
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
|
Ethanol Biomarkers (5-Hydroxytryptophol) in Blood
55 minute collection post-drinking
|
175 ng/mL
Standard Deviation 52
|
187 ng/mL
Standard Deviation 41
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
|
Ethanol Biomarkers (5-Hydroxytryptophol) in Blood
200 minute collection post-drinking
|
331 ng/mL
Standard Deviation 88
|
406 ng/mL
Standard Deviation 104
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
|
Ethanol Biomarkers (5-Hydroxytryptophol) in Blood
215 minute collection post-drinking
|
325 ng/mL
Standard Deviation 94
|
337 ng/mL
Standard Deviation 116
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
PRIMARY outcome
Timeframe: 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-drinkingPopulation: Ethanol Biomarkers (5-Hydroxytryptophol) in Oral Fluid ng/mL
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.
Outcome measures
| Measure |
Active Drink: Placebo Vape
n=7 Participants
Beverage with 50% ethanol (dosed to have the participant reach a 0.08% BAC) and E-cigarette liquid without ethanol
|
Active Drink: Active Vape
n=7 Participants
Beverage with 50% ethanol (dosed to have the participant reach a 0.08% BAC) and E-cigarette liquid with 20% ethanol
|
Placebo Drink: Placebo Vape
n=7 Participants
Beverage without ethanol and E-cigarette liquid without ethanol
|
Placebo Drink: Active Vape
n=7 Participants
Beverage without ethanol and E-cigarette liquid with 20% ethanol
|
|---|---|---|---|---|
|
Ethanol Biomarkers (5-Hydroxytryptophol) in Analyzed in Oral Fluid
Baseline
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
|
Ethanol Biomarkers (5-Hydroxytryptophol) in Analyzed in Oral Fluid
0 minute collection post-drinking
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
|
Ethanol Biomarkers (5-Hydroxytryptophol) in Analyzed in Oral Fluid
5 minute collection post-drinking
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
|
Ethanol Biomarkers (5-Hydroxytryptophol) in Analyzed in Oral Fluid
20 minute collection post-drinking
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
|
Ethanol Biomarkers (5-Hydroxytryptophol) in Analyzed in Oral Fluid
40 minute collection post-drinking
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
|
Ethanol Biomarkers (5-Hydroxytryptophol) in Analyzed in Oral Fluid
55 minute collection post-drinking
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
|
Ethanol Biomarkers (5-Hydroxytryptophol) in Analyzed in Oral Fluid
200 minute collection post-drinking
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
|
Ethanol Biomarkers (5-Hydroxytryptophol) in Analyzed in Oral Fluid
215 minute collection post-drinking
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
|
Ethanol Biomarkers (5-Hydroxytryptophol) in Analyzed in Oral Fluid
240 minute collection post-drinking
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
PRIMARY outcome
Timeframe: 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.Population: Ethanol Biomarkers (5-Hydroxyindoleacetic Acid) in Oral Fluid ng/mL
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.
Outcome measures
| Measure |
Active Drink: Placebo Vape
n=7 Participants
Beverage with 50% ethanol (dosed to have the participant reach a 0.08% BAC) and E-cigarette liquid without ethanol
|
Active Drink: Active Vape
n=7 Participants
Beverage with 50% ethanol (dosed to have the participant reach a 0.08% BAC) and E-cigarette liquid with 20% ethanol
|
Placebo Drink: Placebo Vape
n=7 Participants
Beverage without ethanol and E-cigarette liquid without ethanol
|
Placebo Drink: Active Vape
n=7 Participants
Beverage without ethanol and E-cigarette liquid with 20% ethanol
|
|---|---|---|---|---|
|
Ethanol Biomarkers (5-Hydroxyindoleacetic Acid) Analyzed in Oral Fluid
5 minute collection post-drinking
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
|
Ethanol Biomarkers (5-Hydroxyindoleacetic Acid) Analyzed in Oral Fluid
20 minute collection post-drinking
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
|
Ethanol Biomarkers (5-Hydroxyindoleacetic Acid) Analyzed in Oral Fluid
40 minute collection post-drinking
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
|
Ethanol Biomarkers (5-Hydroxyindoleacetic Acid) Analyzed in Oral Fluid
55 minute collection post-drinking
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
|
Ethanol Biomarkers (5-Hydroxyindoleacetic Acid) Analyzed in Oral Fluid
200 minute collection post-drinking
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
|
Ethanol Biomarkers (5-Hydroxyindoleacetic Acid) Analyzed in Oral Fluid
215 minute collection post-drinking
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
|
Ethanol Biomarkers (5-Hydroxyindoleacetic Acid) Analyzed in Oral Fluid
240 minute collection post-drinking
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
|
Ethanol Biomarkers (5-Hydroxyindoleacetic Acid) Analyzed in Oral Fluid
Baseline Collection
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
|
Ethanol Biomarkers (5-Hydroxyindoleacetic Acid) Analyzed in Oral Fluid
0 minute collection post-drinking
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
PRIMARY outcome
Timeframe: 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-drinkingPopulation: Ethanol Biomarkers (Ethyl Sulfate) in Oral Fluid ng/mL
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.
Outcome measures
| Measure |
Active Drink: Placebo Vape
n=7 Participants
Beverage with 50% ethanol (dosed to have the participant reach a 0.08% BAC) and E-cigarette liquid without ethanol
|
Active Drink: Active Vape
n=7 Participants
Beverage with 50% ethanol (dosed to have the participant reach a 0.08% BAC) and E-cigarette liquid with 20% ethanol
|
Placebo Drink: Placebo Vape
n=7 Participants
Beverage without ethanol and E-cigarette liquid without ethanol
|
Placebo Drink: Active Vape
n=7 Participants
Beverage without ethanol and E-cigarette liquid with 20% ethanol
|
|---|---|---|---|---|
|
Ethanol Biomarkers (Ethyl Sulfate) Analyzed in Oral Fluid
Baseline Collection
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
|
Ethanol Biomarkers (Ethyl Sulfate) Analyzed in Oral Fluid
0 minute collection post-drinking
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
|
Ethanol Biomarkers (Ethyl Sulfate) Analyzed in Oral Fluid
5 minute collection post-drinking
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
|
Ethanol Biomarkers (Ethyl Sulfate) Analyzed in Oral Fluid
20 minute collection post-drinking
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
|
Ethanol Biomarkers (Ethyl Sulfate) Analyzed in Oral Fluid
40 minute collection post-drinking
|
8 ng/mL
Standard Deviation 21
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
|
Ethanol Biomarkers (Ethyl Sulfate) Analyzed in Oral Fluid
55 minute collection post-drinking
|
26 ng/mL
Standard Deviation 49
|
8 ng/mL
Standard Deviation 21
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
|
Ethanol Biomarkers (Ethyl Sulfate) Analyzed in Oral Fluid
200 minute collection post-drinking
|
25 ng/mL
Standard Deviation 47
|
53 ng/mL
Standard Deviation 103
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
|
Ethanol Biomarkers (Ethyl Sulfate) Analyzed in Oral Fluid
215 minute collection post-drinking
|
29 ng/mL
Standard Deviation 37
|
19 ng/mL
Standard Deviation 33
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
|
Ethanol Biomarkers (Ethyl Sulfate) Analyzed in Oral Fluid
240 minute collection post-drinking
|
33 ng/mL
Standard Deviation 61
|
44 ng/mL
Standard Deviation 58
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
PRIMARY outcome
Timeframe: 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.Population: Ethanol Biomarkers (Phosphatidylethanol 16:0-18:1) in Oral Fluid ng/mL
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.
Outcome measures
| Measure |
Active Drink: Placebo Vape
n=7 Participants
Beverage with 50% ethanol (dosed to have the participant reach a 0.08% BAC) and E-cigarette liquid without ethanol
|
Active Drink: Active Vape
n=7 Participants
Beverage with 50% ethanol (dosed to have the participant reach a 0.08% BAC) and E-cigarette liquid with 20% ethanol
|
Placebo Drink: Placebo Vape
n=7 Participants
Beverage without ethanol and E-cigarette liquid without ethanol
|
Placebo Drink: Active Vape
n=7 Participants
Beverage without ethanol and E-cigarette liquid with 20% ethanol
|
|---|---|---|---|---|
|
Ethanol Biomarkers (Phosphatidylethanol 16:0-18:1) Analyzed in Blood
Baseline Collection
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
|
Ethanol Biomarkers (Phosphatidylethanol 16:0-18:1) Analyzed in Blood
0 minute collection post-drinking
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
|
Ethanol Biomarkers (Phosphatidylethanol 16:0-18:1) Analyzed in Blood
5 minute collection post-drinking
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
|
Ethanol Biomarkers (Phosphatidylethanol 16:0-18:1) Analyzed in Blood
20 minute collection post-drinking
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
|
Ethanol Biomarkers (Phosphatidylethanol 16:0-18:1) Analyzed in Blood
40 minute collection post-drinking
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
|
Ethanol Biomarkers (Phosphatidylethanol 16:0-18:1) Analyzed in Blood
55 minute collection post-drinking
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
|
Ethanol Biomarkers (Phosphatidylethanol 16:0-18:1) Analyzed in Blood
200 minute collection post-drinking
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
|
Ethanol Biomarkers (Phosphatidylethanol 16:0-18:1) Analyzed in Blood
215 minute collection post-drinking
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
|
Ethanol Biomarkers (Phosphatidylethanol 16:0-18:1) Analyzed in Blood
240 minute collection post-drinking
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
PRIMARY outcome
Timeframe: 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.Population: Ethanol Biomarkers (Phosphatidylethanol 16:0-18:2) in Oral Fluid ng/mL
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.
Outcome measures
| Measure |
Active Drink: Placebo Vape
n=7 Participants
Beverage with 50% ethanol (dosed to have the participant reach a 0.08% BAC) and E-cigarette liquid without ethanol
|
Active Drink: Active Vape
n=7 Participants
Beverage with 50% ethanol (dosed to have the participant reach a 0.08% BAC) and E-cigarette liquid with 20% ethanol
|
Placebo Drink: Placebo Vape
n=7 Participants
Beverage without ethanol and E-cigarette liquid without ethanol
|
Placebo Drink: Active Vape
n=7 Participants
Beverage without ethanol and E-cigarette liquid with 20% ethanol
|
|---|---|---|---|---|
|
Ethanol Biomarkers (Phosphatidylethanol 16:0-18:2) in Oral Fluid
Baseline Collection
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
|
Ethanol Biomarkers (Phosphatidylethanol 16:0-18:2) in Oral Fluid
0 minute collection post-drinking
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
|
Ethanol Biomarkers (Phosphatidylethanol 16:0-18:2) in Oral Fluid
20 minute collection post-drinking
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
|
Ethanol Biomarkers (Phosphatidylethanol 16:0-18:2) in Oral Fluid
40 minute collection post-drinking
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
|
Ethanol Biomarkers (Phosphatidylethanol 16:0-18:2) in Oral Fluid
240 minute collection post-drinking
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
|
Ethanol Biomarkers (Phosphatidylethanol 16:0-18:2) in Oral Fluid
55 minute collection post-drinking
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
|
Ethanol Biomarkers (Phosphatidylethanol 16:0-18:2) in Oral Fluid
200 minute collection post-drinking
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
|
Ethanol Biomarkers (Phosphatidylethanol 16:0-18:2) in Oral Fluid
215 minute collection post-drinking
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
PRIMARY outcome
Timeframe: 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.Population: Ethanol Biomarkers (5-Hydroxytryptophol Glucuronide) ng/mL
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.
Outcome measures
| Measure |
Active Drink: Placebo Vape
n=7 Participants
Beverage with 50% ethanol (dosed to have the participant reach a 0.08% BAC) and E-cigarette liquid without ethanol
|
Active Drink: Active Vape
n=7 Participants
Beverage with 50% ethanol (dosed to have the participant reach a 0.08% BAC) and E-cigarette liquid with 20% ethanol
|
Placebo Drink: Placebo Vape
n=7 Participants
Beverage without ethanol and E-cigarette liquid without ethanol
|
Placebo Drink: Active Vape
n=7 Participants
Beverage without ethanol and E-cigarette liquid with 20% ethanol
|
|---|---|---|---|---|
|
Ethanol Biomarkers (Ethyl Glucuronide) Analyzed in Blood
Baseline Collection
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
|
Ethanol Biomarkers (Ethyl Glucuronide) Analyzed in Blood
0 minute collection post-drinking
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
|
Ethanol Biomarkers (Ethyl Glucuronide) Analyzed in Blood
5 minute collection post-drinking
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
|
Ethanol Biomarkers (Ethyl Glucuronide) Analyzed in Blood
20 minute collection post-drinking
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
|
Ethanol Biomarkers (Ethyl Glucuronide) Analyzed in Blood
40 minute collection post-drinking
|
145 ng/mL
Standard Deviation 53
|
128 ng/mL
Standard Deviation 29
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
|
Ethanol Biomarkers (Ethyl Glucuronide) Analyzed in Blood
55 minute collection post-drinking
|
175 ng/mL
Standard Deviation 52
|
187 ng/mL
Standard Deviation 41
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
|
Ethanol Biomarkers (Ethyl Glucuronide) Analyzed in Blood
200 minute collection post-drinking
|
331 ng/mL
Standard Deviation 88
|
406 ng/mL
Standard Deviation 104
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
|
Ethanol Biomarkers (Ethyl Glucuronide) Analyzed in Blood
215 minute collection post-drinking
|
325 ng/mL
Standard Deviation 94
|
337 ng/mL
Standard Deviation 116
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
|
Ethanol Biomarkers (Ethyl Glucuronide) Analyzed in Blood
240 minute collection post-drinking
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
PRIMARY outcome
Timeframe: 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-drinkingPopulation: Ethanol Biomarkers (Ethyl Glucuronide) in Oral Fluid ng/mL
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.
Outcome measures
| Measure |
Active Drink: Placebo Vape
n=7 Participants
Beverage with 50% ethanol (dosed to have the participant reach a 0.08% BAC) and E-cigarette liquid without ethanol
|
Active Drink: Active Vape
n=7 Participants
Beverage with 50% ethanol (dosed to have the participant reach a 0.08% BAC) and E-cigarette liquid with 20% ethanol
|
Placebo Drink: Placebo Vape
n=7 Participants
Beverage without ethanol and E-cigarette liquid without ethanol
|
Placebo Drink: Active Vape
n=7 Participants
Beverage without ethanol and E-cigarette liquid with 20% ethanol
|
|---|---|---|---|---|
|
Ethanol Biomarkers (Ethyl Glucuronide) Analyzed in Oral Fluid
Baseline Collection
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
|
Ethanol Biomarkers (Ethyl Glucuronide) Analyzed in Oral Fluid
0 minute collection post-drinking
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
|
Ethanol Biomarkers (Ethyl Glucuronide) Analyzed in Oral Fluid
5 minute collection post-drinking
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
|
Ethanol Biomarkers (Ethyl Glucuronide) Analyzed in Oral Fluid
20 minute collection post-drinking
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
|
Ethanol Biomarkers (Ethyl Glucuronide) Analyzed in Oral Fluid
40 minute collection post-drinking
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
|
Ethanol Biomarkers (Ethyl Glucuronide) Analyzed in Oral Fluid
55 minute collection post-drinking
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
|
Ethanol Biomarkers (Ethyl Glucuronide) Analyzed in Oral Fluid
200 minute collection post-drinking
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
|
Ethanol Biomarkers (Ethyl Glucuronide) Analyzed in Oral Fluid
215 minute collection post-drinking
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
|
Ethanol Biomarkers (Ethyl Glucuronide) Analyzed in Oral Fluid
240 minute collection post-drinking
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
SECONDARY outcome
Timeframe: 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).Population: Horizontal Gaze Nystagmus # of clues observed
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.
Outcome measures
| Measure |
Active Drink: Placebo Vape
n=7 Participants
Beverage with 50% ethanol (dosed to have the participant reach a 0.08% BAC) and E-cigarette liquid without ethanol
|
Active Drink: Active Vape
n=7 Participants
Beverage with 50% ethanol (dosed to have the participant reach a 0.08% BAC) and E-cigarette liquid with 20% ethanol
|
Placebo Drink: Placebo Vape
n=7 Participants
Beverage without ethanol and E-cigarette liquid without ethanol
|
Placebo Drink: Active Vape
n=7 Participants
Beverage without ethanol and E-cigarette liquid with 20% ethanol
|
|---|---|---|---|---|
|
Horizontal Gaze Nystagmus
Baseline
|
.7 Number of Clues Observed
Standard Deviation 1.0
|
.3 Number of Clues Observed
Standard Deviation .8
|
0 Number of Clues Observed
Standard Deviation 0
|
.9 Number of Clues Observed
Standard Deviation .9
|
|
Horizontal Gaze Nystagmus
Before the 1st Vaping Bout
|
3.1 Number of Clues Observed
Standard Deviation 2.1
|
3.9 Number of Clues Observed
Standard Deviation 1.7
|
.4 Number of Clues Observed
Standard Deviation .8
|
.9 Number of Clues Observed
Standard Deviation .9
|
|
Horizontal Gaze Nystagmus
After the 1st Vaping Bout
|
3.0 Number of Clues Observed
Standard Deviation 1.8
|
3.4 Number of Clues Observed
Standard Deviation 1.7
|
.4 Number of Clues Observed
Standard Deviation .8
|
.9 Number of Clues Observed
Standard Deviation 1.1
|
|
Horizontal Gaze Nystagmus
After the 2nd Vaping Bout
|
.7 Number of Clues Observed
Standard Deviation 1.0
|
1.9 Number of Clues Observed
Standard Deviation 1.3
|
.3 Number of Clues Observed
Standard Deviation .8
|
1.1 Number of Clues Observed
Standard Deviation 1.5
|
SECONDARY outcome
Timeframe: 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).Population: Walk and Turn Test, # of clues observed
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
Outcome measures
| Measure |
Active Drink: Placebo Vape
n=7 Participants
Beverage with 50% ethanol (dosed to have the participant reach a 0.08% BAC) and E-cigarette liquid without ethanol
|
Active Drink: Active Vape
n=7 Participants
Beverage with 50% ethanol (dosed to have the participant reach a 0.08% BAC) and E-cigarette liquid with 20% ethanol
|
Placebo Drink: Placebo Vape
n=7 Participants
Beverage without ethanol and E-cigarette liquid without ethanol
|
Placebo Drink: Active Vape
n=7 Participants
Beverage without ethanol and E-cigarette liquid with 20% ethanol
|
|---|---|---|---|---|
|
Walk and Turn Test
Baseline
|
.9 Number of Clues Observed
Standard Deviation .9
|
.6 Number of Clues Observed
Standard Deviation .5
|
.6 Number of Clues Observed
Standard Deviation .8
|
.9 Number of Clues Observed
Standard Deviation 1.1
|
|
Walk and Turn Test
Before the 1st Vaping Bout
|
1.1 Number of Clues Observed
Standard Deviation 1.3
|
1.1 Number of Clues Observed
Standard Deviation 1.2
|
.4 Number of Clues Observed
Standard Deviation .8
|
.9 Number of Clues Observed
Standard Deviation .7
|
|
Walk and Turn Test
After the 1st Vaping Bout
|
1.0 Number of Clues Observed
Standard Deviation 1.3
|
1.1 Number of Clues Observed
Standard Deviation 1.1
|
.3 Number of Clues Observed
Standard Deviation .5
|
.4 Number of Clues Observed
Standard Deviation .8
|
|
Walk and Turn Test
After the 2nd Vaping Bout
|
.6 Number of Clues Observed
Standard Deviation .5
|
.7 Number of Clues Observed
Standard Deviation .8
|
.1 Number of Clues Observed
Standard Deviation .4
|
.7 Number of Clues Observed
Standard Deviation .8
|
SECONDARY outcome
Timeframe: 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).Population: One leg stand test, # of clues observed
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
Outcome measures
| Measure |
Active Drink: Placebo Vape
n=7 Participants
Beverage with 50% ethanol (dosed to have the participant reach a 0.08% BAC) and E-cigarette liquid without ethanol
|
Active Drink: Active Vape
n=7 Participants
Beverage with 50% ethanol (dosed to have the participant reach a 0.08% BAC) and E-cigarette liquid with 20% ethanol
|
Placebo Drink: Placebo Vape
n=7 Participants
Beverage without ethanol and E-cigarette liquid without ethanol
|
Placebo Drink: Active Vape
n=7 Participants
Beverage without ethanol and E-cigarette liquid with 20% ethanol
|
|---|---|---|---|---|
|
One Leg Stand Test
Before the 1st Vaping Bout
|
.9 Number of Clues observed
Standard Deviation 1.5
|
1 Number of Clues observed
Standard Deviation 1.3
|
.3 Number of Clues observed
Standard Deviation .5
|
0 Number of Clues observed
Standard Deviation 0
|
|
One Leg Stand Test
Baseline
|
.4 Number of Clues observed
Standard Deviation .5
|
.7 Number of Clues observed
Standard Deviation .8
|
.6 Number of Clues observed
Standard Deviation .8
|
.7 Number of Clues observed
Standard Deviation 1.1
|
|
One Leg Stand Test
After the 1st Vaping Bout
|
.4 Number of Clues observed
Standard Deviation .8
|
1.1 Number of Clues observed
Standard Deviation 1.3
|
.6 Number of Clues observed
Standard Deviation .8
|
.3 Number of Clues observed
Standard Deviation .5
|
|
One Leg Stand Test
After the 2nd Vaping Bout
|
.3 Number of Clues observed
Standard Deviation .5
|
.4 Number of Clues observed
Standard Deviation .8
|
.6 Number of Clues observed
Standard Deviation .8
|
.3 Number of Clues observed
Standard Deviation .5
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Administered at baseline, 55 minutes post-drinking (after first vape bout), and 215 minutes post-drinking (after second vape bout).Population: Subjective High Assessment Scale Questionnaire (SHAS) Total score
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.
Outcome measures
| Measure |
Active Drink: Placebo Vape
n=7 Participants
Beverage with 50% ethanol (dosed to have the participant reach a 0.08% BAC) and E-cigarette liquid without ethanol
|
Active Drink: Active Vape
n=7 Participants
Beverage with 50% ethanol (dosed to have the participant reach a 0.08% BAC) and E-cigarette liquid with 20% ethanol
|
Placebo Drink: Placebo Vape
n=7 Participants
Beverage without ethanol and E-cigarette liquid without ethanol
|
Placebo Drink: Active Vape
n=7 Participants
Beverage without ethanol and E-cigarette liquid with 20% ethanol
|
|---|---|---|---|---|
|
Subjective High Assessment Scale Questionnaire (SHAS)
Baseline
|
38 SHAS Total score
Standard Deviation 41
|
29 SHAS Total score
Standard Deviation 30
|
60 SHAS Total score
Standard Deviation 74
|
58 SHAS Total score
Standard Deviation 75
|
|
Subjective High Assessment Scale Questionnaire (SHAS)
After e-cig use at 55 minutes
|
244 SHAS Total score
Standard Deviation 271
|
286 SHAS Total score
Standard Deviation 241
|
91 SHAS Total score
Standard Deviation 64
|
78 SHAS Total score
Standard Deviation 71
|
|
Subjective High Assessment Scale Questionnaire (SHAS)
After e-cig use at 215 minutes
|
105 SHAS Total score
Standard Deviation 132
|
172 SHAS Total score
Standard Deviation 229
|
52 SHAS Total score
Standard Deviation 47
|
48 SHAS Total score
Standard Deviation 51
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Administered at baseline, 55 minutes post-drinking (after first vape bout), and 215 minutes post-drinking (after second vape bout).Population: Biphasic Alcohol Effects Scale Questionnaire (BAES) total score
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.
Outcome measures
| Measure |
Active Drink: Placebo Vape
n=7 Participants
Beverage with 50% ethanol (dosed to have the participant reach a 0.08% BAC) and E-cigarette liquid without ethanol
|
Active Drink: Active Vape
n=7 Participants
Beverage with 50% ethanol (dosed to have the participant reach a 0.08% BAC) and E-cigarette liquid with 20% ethanol
|
Placebo Drink: Placebo Vape
n=7 Participants
Beverage without ethanol and E-cigarette liquid without ethanol
|
Placebo Drink: Active Vape
n=7 Participants
Beverage without ethanol and E-cigarette liquid with 20% ethanol
|
|---|---|---|---|---|
|
Biphasic Alcohol Effects Scale Questionnaire (BAES)
After e-cig use at 55 minutes
|
33 (BAES) total score
Standard Deviation 17
|
36 (BAES) total score
Standard Deviation 14
|
22 (BAES) total score
Standard Deviation 11
|
25 (BAES) total score
Standard Deviation 11
|
|
Biphasic Alcohol Effects Scale Questionnaire (BAES)
Baseline
|
28 (BAES) total score
Standard Deviation 15
|
25 (BAES) total score
Standard Deviation 14
|
22 (BAES) total score
Standard Deviation 15
|
25 (BAES) total score
Standard Deviation 11
|
|
Biphasic Alcohol Effects Scale Questionnaire (BAES)
After e-cig use at 215 minutes
|
28 (BAES) total score
Standard Deviation 12
|
32 (BAES) total score
Standard Deviation 12
|
24 (BAES) total score
Standard Deviation 14
|
24 (BAES) total score
Standard Deviation 14
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Administered at baseline, 55 minutes post-drinking (after first vape bout), and 215 minutes post-drinking (after second vape bout).Population: General Labeled Magnitude Scale Questionnaire (gLMS) total score
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.
Outcome measures
| Measure |
Active Drink: Placebo Vape
n=7 Participants
Beverage with 50% ethanol (dosed to have the participant reach a 0.08% BAC) and E-cigarette liquid without ethanol
|
Active Drink: Active Vape
n=7 Participants
Beverage with 50% ethanol (dosed to have the participant reach a 0.08% BAC) and E-cigarette liquid with 20% ethanol
|
Placebo Drink: Placebo Vape
n=7 Participants
Beverage without ethanol and E-cigarette liquid without ethanol
|
Placebo Drink: Active Vape
n=7 Participants
Beverage without ethanol and E-cigarette liquid with 20% ethanol
|
|---|---|---|---|---|
|
General Labeled Magnitude Scale Questionnaire (gLMS)
Baseline
|
0 (gLMS) total score
Standard Deviation 0
|
0 (gLMS) total score
Standard Deviation 0
|
0 (gLMS) total score
Standard Deviation 0
|
0 (gLMS) total score
Standard Deviation 0
|
|
General Labeled Magnitude Scale Questionnaire (gLMS)
After e-cig use at 55 minutes
|
86 (gLMS) total score
Standard Deviation 66
|
105 (gLMS) total score
Standard Deviation 57
|
91 (gLMS) total score
Standard Deviation 51
|
108 (gLMS) total score
Standard Deviation 58
|
|
General Labeled Magnitude Scale Questionnaire (gLMS)
After e-cig use at 215 minutes
|
101 (gLMS) total score
Standard Deviation 61
|
81 (gLMS) total score
Standard Deviation 69
|
83 (gLMS) total score
Standard Deviation 63
|
105 (gLMS) total score
Standard Deviation 67
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Administered at baseline, 55 minutes post-drinking (after first vape bout), and 215 minutes post-drinking (after second vape bout).Population: Labeled Hedonic Scale Questionnaire (LHS) total score
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
Outcome measures
| Measure |
Active Drink: Placebo Vape
n=7 Participants
Beverage with 50% ethanol (dosed to have the participant reach a 0.08% BAC) and E-cigarette liquid without ethanol
|
Active Drink: Active Vape
n=7 Participants
Beverage with 50% ethanol (dosed to have the participant reach a 0.08% BAC) and E-cigarette liquid with 20% ethanol
|
Placebo Drink: Placebo Vape
n=7 Participants
Beverage without ethanol and E-cigarette liquid without ethanol
|
Placebo Drink: Active Vape
n=7 Participants
Beverage without ethanol and E-cigarette liquid with 20% ethanol
|
|---|---|---|---|---|
|
Labeled Hedonic Scale Questionnaire (LHS)
Baseline
|
0 (LHS) total score
Standard Deviation 0
|
0 (LHS) total score
Standard Deviation 0
|
0 (LHS) total score
Standard Deviation 0
|
0 (LHS) total score
Standard Deviation 0
|
|
Labeled Hedonic Scale Questionnaire (LHS)
After e-cig use at 55 minutes
|
184 (LHS) total score
Standard Deviation 71
|
165 (LHS) total score
Standard Deviation 66
|
161 (LHS) total score
Standard Deviation 37
|
125 (LHS) total score
Standard Deviation 42
|
|
Labeled Hedonic Scale Questionnaire (LHS)
After e-cig use at 215 minutes
|
152 (LHS) total score
Standard Deviation 81
|
152 (LHS) total score
Standard Deviation 61
|
180 (LHS) total score
Standard Deviation 44
|
121 (LHS) total score
Standard Deviation 55
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Administered at baseline, 55 minutes post-drinking (after first vape bout), and 215 minutes post-drinking (after second vape bout).Population: Direct Effects of Vaping Questionnaire (DEPVQ) total score
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.
Outcome measures
| Measure |
Active Drink: Placebo Vape
n=7 Participants
Beverage with 50% ethanol (dosed to have the participant reach a 0.08% BAC) and E-cigarette liquid without ethanol
|
Active Drink: Active Vape
n=7 Participants
Beverage with 50% ethanol (dosed to have the participant reach a 0.08% BAC) and E-cigarette liquid with 20% ethanol
|
Placebo Drink: Placebo Vape
n=7 Participants
Beverage without ethanol and E-cigarette liquid without ethanol
|
Placebo Drink: Active Vape
n=7 Participants
Beverage without ethanol and E-cigarette liquid with 20% ethanol
|
|---|---|---|---|---|
|
Direct Effects of Vaping Questionnaire (DEPVQ)
After e-cig use at 55 minutes
|
289 (DEPVQ) total score
Standard Deviation 183
|
309 (DEPVQ) total score
Standard Deviation 136
|
320 (DEPVQ) total score
Standard Deviation 132
|
259 (DEPVQ) total score
Standard Deviation 151
|
|
Direct Effects of Vaping Questionnaire (DEPVQ)
After e-cig use at 215 minutes
|
259 (DEPVQ) total score
Standard Deviation 112
|
243 (DEPVQ) total score
Standard Deviation 128
|
255 (DEPVQ) total score
Standard Deviation 117
|
205 (DEPVQ) total score
Standard Deviation 108
|
|
Direct Effects of Vaping Questionnaire (DEPVQ)
Baseline
|
0 (DEPVQ) total score
Standard Deviation 0
|
0 (DEPVQ) total score
Standard Deviation 0
|
0 (DEPVQ) total score
Standard Deviation 0
|
0 (DEPVQ) total score
Standard Deviation 0
|
Adverse Events
Within Group Four Condition Comparison
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Within Group Four Condition Comparison
n=7 participants at risk
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. Session interventions were as follows:
* Placebo drink: Placebo vape (Beverage without ethanol and E-cigarette liquid without ethanol)
* Placebo drink: Active vape (Beverage without ethanol and E-cigarette liquid with 20% ethanol)
* Active drink: Placebo vape (Beverage with 50% ethanol (dosed to have the participant reach a 0.08% BAC) and E-cigarette liquid without ethanol)
* Active drink: Active vape (Beverage with 50% ethanol (dosed to have the participant reach a 0.08% BAC) and E-cigarette liquid with 20% ethanol)
|
|---|---|
|
Injury, poisoning and procedural complications
nausea
|
28.6%
2/7 • Number of events 2 • From baseline to session completion, approximately 7 hours for each session. On average, participants completed all 4 sessions within 1 month.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place