Trial Outcomes & Findings for Evaluating the Comparative Pharmacokinetics of Nicotine After Administration Via JUUL or Tobacco Cigarettes (NCT NCT04053868)
NCT ID: NCT04053868
Last Updated: 2025-10-16
Results Overview
Plasma nicotine area under the concentrated time curve (AUC) (ng/ml\*h)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
17 participants
Primary outcome timeframe
Plasma collected at baseline (prior to any product use) and at 2, 5, 7, 10, 15, 30, 60, 90, and 118 minutes after end of standardized session.
Results posted on
2025-10-16
Participant Flow
Current users of nicotine were recruited from the San Francisco Bay Area as healthy volunteers for this study.
Participant milestones
| Measure |
EC Day 1/TC Day 2
Participants will be randomized into one of two groups. In this group, participants will be assigned to exclusively use a JUUL e-cigarette (EC) on Study Day 1. They will then crossover to exclusively use a tobacco cigarette (TC) on Study Day 2. They will vape the e-cigarette during a Standardized Session (one 3.5 second puff every 30 seconds for a total of 10 puffs) followed by a 2.5 hour abstinence period. They will then vape as they wish for 4 hours.
Electronic cigarette (EC): JUUL e-cigarette device with a JUUL e-liquid pod.
Tobacco cigarette (TC): Participants' usual brand of tobacco cigarettes.
|
TC Day 1/EC Day 2
Participants will be randomized into one of two groups. In this group, participants will be assigned to exclusively use a tobacco cigarette (TC) on Study Day 1. They will then crossover to exclusively use a JUUL e-cigarette (EC) on Study Day 2. They will smoke the tobacco cigarette during a Standardized Session (one 3.5 second puff every 30 seconds for a total of 10 puffs) followed by a 2.5 hour abstinence period. They will then smoke as they wish for 4 hours.
Electronic cigarette (EC): JUUL e-cigarette device with a JUUL e-liquid pod.
Tobacco cigarette (TC): Participants' usual brand of tobacco cigarettes.
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|---|---|---|
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Overall Study
STARTED
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10
|
7
|
|
Overall Study
COMPLETED
|
9
|
7
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
EC Day 1/TC Day 2
Participants will be randomized into one of two groups. In this group, participants will be assigned to exclusively use a JUUL e-cigarette (EC) on Study Day 1. They will then crossover to exclusively use a tobacco cigarette (TC) on Study Day 2. They will vape the e-cigarette during a Standardized Session (one 3.5 second puff every 30 seconds for a total of 10 puffs) followed by a 2.5 hour abstinence period. They will then vape as they wish for 4 hours.
Electronic cigarette (EC): JUUL e-cigarette device with a JUUL e-liquid pod.
Tobacco cigarette (TC): Participants' usual brand of tobacco cigarettes.
|
TC Day 1/EC Day 2
Participants will be randomized into one of two groups. In this group, participants will be assigned to exclusively use a tobacco cigarette (TC) on Study Day 1. They will then crossover to exclusively use a JUUL e-cigarette (EC) on Study Day 2. They will smoke the tobacco cigarette during a Standardized Session (one 3.5 second puff every 30 seconds for a total of 10 puffs) followed by a 2.5 hour abstinence period. They will then smoke as they wish for 4 hours.
Electronic cigarette (EC): JUUL e-cigarette device with a JUUL e-liquid pod.
Tobacco cigarette (TC): Participants' usual brand of tobacco cigarettes.
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|---|---|---|
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Overall Study
Withdrawal by Subject
|
1
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0
|
Baseline Characteristics
Evaluating the Comparative Pharmacokinetics of Nicotine After Administration Via JUUL or Tobacco Cigarettes
Baseline characteristics by cohort
| Measure |
Overall Study
n=17 Participants
Participants will exclusively use a JUUL E-cigarette device with a JUUL e-liquid pod on one study day and then exclusively a traditional tobacco cigarette on the other study day. The order in which the products are used are randomized using a Latin Square design. All participants will use both products (e-cigarette and tobacco cigarette).
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|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
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Age, Categorical
Between 18 and 65 years
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17 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
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0 Participants
n=99 Participants
|
|
Age, Continuous
|
32.5 years
STANDARD_DEVIATION 8.4 • n=99 Participants
|
|
Sex: Female, Male
Female
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6 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
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0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
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13 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
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Region of Enrollment
United States
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17 participants
n=99 Participants
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PRIMARY outcome
Timeframe: Plasma collected at baseline (prior to any product use) and at 2, 5, 7, 10, 15, 30, 60, 90, and 118 minutes after end of standardized session.Plasma nicotine area under the concentrated time curve (AUC) (ng/ml\*h)
Outcome measures
| Measure |
E-cigarette (JUUL)
n=16 Participants
Participants will exclusively use a JUUL E-cigarette device with a JUUL e-liquid pod on one of the study days. They will vape the e-cigarette during a Standardized Session (one 3.5 second puff every 30 seconds for a total of 10 puffs) followed by a 2.5 hour abstinence period. They will then vape as they wish for 4 hours.
|
Tobacco Cigarette
n=16 Participants
Participants will exclusively use a tobacco cigarette on one of the study days. They will smoke the cigarette during a Standardized Session (one 3.5 second puff every 30 seconds for a total of 10 puffs) followed by a 2.5 hour abstinence period. They will then smoke as they wish for 4 hours.
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|---|---|---|
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Mean Nicotine Exposure
|
4.6 ng/ml*h
Standard Deviation 2.2
|
9.2 ng/ml*h
Standard Deviation 5.8
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SECONDARY outcome
Timeframe: Up to 118 minutes after end of standardized session.Participant heart rate will be measured in beats per minute (bpm) at baseline (before any use of products) and at 2, 5, 7, 10, 15, 30, 45, 60, 75, 90, 100,and 118 minutes after the standardized sessions of e-cigarette and tobacco cigarette use. The mean of each time point will be averaged over time.
Outcome measures
| Measure |
E-cigarette (JUUL)
n=16 Participants
Participants will exclusively use a JUUL E-cigarette device with a JUUL e-liquid pod on one of the study days. They will vape the e-cigarette during a Standardized Session (one 3.5 second puff every 30 seconds for a total of 10 puffs) followed by a 2.5 hour abstinence period. They will then vape as they wish for 4 hours.
|
Tobacco Cigarette
n=16 Participants
Participants will exclusively use a tobacco cigarette on one of the study days. They will smoke the cigarette during a Standardized Session (one 3.5 second puff every 30 seconds for a total of 10 puffs) followed by a 2.5 hour abstinence period. They will then smoke as they wish for 4 hours.
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|---|---|---|
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Overall Mean Heart Rate Over Time
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69.4 bpm
Standard Deviation 11.6
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73.4 bpm
Standard Deviation 13.1
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SECONDARY outcome
Timeframe: Up to 118 minutes after end of standardized session.Participant systolic blood pressure will be taken at Baseline (prior to use of any product) and at 5, 10, 15, 30, 45, 60, 75, 90, 100, and 118 minutes after the standardized sessions of e-cigarette and/or tobacco cigarette use on each arm. The mean of each time point will be averaged over time.
Outcome measures
| Measure |
E-cigarette (JUUL)
n=16 Participants
Participants will exclusively use a JUUL E-cigarette device with a JUUL e-liquid pod on one of the study days. They will vape the e-cigarette during a Standardized Session (one 3.5 second puff every 30 seconds for a total of 10 puffs) followed by a 2.5 hour abstinence period. They will then vape as they wish for 4 hours.
|
Tobacco Cigarette
n=16 Participants
Participants will exclusively use a tobacco cigarette on one of the study days. They will smoke the cigarette during a Standardized Session (one 3.5 second puff every 30 seconds for a total of 10 puffs) followed by a 2.5 hour abstinence period. They will then smoke as they wish for 4 hours.
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|---|---|---|
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Mean Systolic Blood Pressure Over Time
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123 mmHg
Standard Deviation 12.3
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122 mmHg
Standard Deviation 11.8
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SECONDARY outcome
Timeframe: Up to 118 minutes after end of standardized session.Participant diastolic blood pressure will be taken at Baseline (prior to use of any product) and at 5, 10, 15, 30, 45, 60, 75, 90, 100, and 118 minutes after the standardized session during e-cigarette and/or tobacco cigarette use on each arm. The mean of each time point will be averaged over time.
Outcome measures
| Measure |
E-cigarette (JUUL)
n=16 Participants
Participants will exclusively use a JUUL E-cigarette device with a JUUL e-liquid pod on one of the study days. They will vape the e-cigarette during a Standardized Session (one 3.5 second puff every 30 seconds for a total of 10 puffs) followed by a 2.5 hour abstinence period. They will then vape as they wish for 4 hours.
|
Tobacco Cigarette
n=16 Participants
Participants will exclusively use a tobacco cigarette on one of the study days. They will smoke the cigarette during a Standardized Session (one 3.5 second puff every 30 seconds for a total of 10 puffs) followed by a 2.5 hour abstinence period. They will then smoke as they wish for 4 hours.
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|---|---|---|
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Mean Diastolic Blood Pressure Over Time
|
75.6 mmHg
Standard Deviation 12
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76.9 mmHg
Standard Deviation 10.6
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SECONDARY outcome
Timeframe: Up to 118 minutes after end of standardized sessionThe QSU (Questionnaire of Smoking Urges) is a self-report survey, modified to replace "cigarette" with "e-cigarette" and "smoking" with "vaping" for use during both the tobacco cigarette and the E-cigarette Arm. This instrument is composed of 10 items; 5 items measuring desire/intention to smoke/vape with smoking/vaping perceived as rewarding (Factor 1), and 5 items measuring anticipation of relief from negative affect with an urgent desire to smoke/vape (Factor 2). Scores for each factor (1 and 2) range from 5-35 with higher scores indicating more severe craving. The mean and standard deviation will be reported.
Outcome measures
| Measure |
E-cigarette (JUUL)
n=15 Participants
Participants will exclusively use a JUUL E-cigarette device with a JUUL e-liquid pod on one of the study days. They will vape the e-cigarette during a Standardized Session (one 3.5 second puff every 30 seconds for a total of 10 puffs) followed by a 2.5 hour abstinence period. They will then vape as they wish for 4 hours.
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Tobacco Cigarette
n=15 Participants
Participants will exclusively use a tobacco cigarette on one of the study days. They will smoke the cigarette during a Standardized Session (one 3.5 second puff every 30 seconds for a total of 10 puffs) followed by a 2.5 hour abstinence period. They will then smoke as they wish for 4 hours.
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|---|---|---|
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Mean Questionnaire of Smoking Urges (QSU) and Modified for E-cigarettes (mQSU) Score Over Time
Factor 1: desire/intention to smoke/vape with smoking/vaping perceived as rewarding
|
20.9 score on a scale
Standard Deviation 9.62
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19.0 score on a scale
Standard Deviation 9.96
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Mean Questionnaire of Smoking Urges (QSU) and Modified for E-cigarettes (mQSU) Score Over Time
Factor 2: anticipation of relief from negative affect with an urgent desire to smoke/vape
|
13.5 score on a scale
Standard Deviation 8.72
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11.3 score on a scale
Standard Deviation 8.28
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SECONDARY outcome
Timeframe: Up to 118 minutes after end of standardized session.The Minnesota Nicotine Withdrawal Scale is an 15-item self -report scale designed to measure the severity of craving and withdrawal symptoms experienced during smoking cessation. Each item is on a scale of 0 to 4 with 0=none to 4=Severe. The responses to each item are summed to produce a total withdrawal summary score with a possible range between 0 and 60, with higher scores indicating greater withdrawal symptom severity with greater scores indicating a higher level of severity in nicotine withdrawal symptoms overall. The mean and standard deviation will be reported.
Outcome measures
| Measure |
E-cigarette (JUUL)
n=15 Participants
Participants will exclusively use a JUUL E-cigarette device with a JUUL e-liquid pod on one of the study days. They will vape the e-cigarette during a Standardized Session (one 3.5 second puff every 30 seconds for a total of 10 puffs) followed by a 2.5 hour abstinence period. They will then vape as they wish for 4 hours.
|
Tobacco Cigarette
n=15 Participants
Participants will exclusively use a tobacco cigarette on one of the study days. They will smoke the cigarette during a Standardized Session (one 3.5 second puff every 30 seconds for a total of 10 puffs) followed by a 2.5 hour abstinence period. They will then smoke as they wish for 4 hours.
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|---|---|---|
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Mean Minnesota Nicotine Withdrawal Scale (MNWS) Score Over Time
|
12 score on a scale
Standard Deviation 8.75
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11 score on a scale
Standard Deviation 8.03
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SECONDARY outcome
Timeframe: Up to 240 minutes after end of standardized sessionThe CES is a self-report survey measuring smoking/vaping satisfaction, psychological reward, aversion, sensations, and craving reduction. This 12-item instrument has a total score range from 12 to 84, with higher scores indicating higher perception of the above factors. The mean and standard deviation will be reported.
Outcome measures
| Measure |
E-cigarette (JUUL)
n=15 Participants
Participants will exclusively use a JUUL E-cigarette device with a JUUL e-liquid pod on one of the study days. They will vape the e-cigarette during a Standardized Session (one 3.5 second puff every 30 seconds for a total of 10 puffs) followed by a 2.5 hour abstinence period. They will then vape as they wish for 4 hours.
|
Tobacco Cigarette
n=15 Participants
Participants will exclusively use a tobacco cigarette on one of the study days. They will smoke the cigarette during a Standardized Session (one 3.5 second puff every 30 seconds for a total of 10 puffs) followed by a 2.5 hour abstinence period. They will then smoke as they wish for 4 hours.
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|---|---|---|
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Mean Cigarette Evaluation Scale (CES) and Modified for E-cigarettes (mCES) Score Over Time
|
49.5 score on a scale
Standard Deviation 12.87
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47.7 score on a scale
Standard Deviation 14.18
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Adverse Events
Electronic Cigarette
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Tobacco Cigarette
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Electronic Cigarette
n=16 participants at risk
The participants will use a JUUL e-cigarette device with a JUUL e-liquid pod in a standardized vaping session consisting of one 3.5 second puff every 30 seconds for a total of 10 puffs. This will be followed by a 2.5 hour abstinence period. They will then use the JUUL e-cigarette as they wish (ad-lib use) for 4 hours.
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Tobacco Cigarette
n=16 participants at risk
The participants will use a tobacco cigarette in a standardized smoking session consisting of one 3.5 second puff every 30 seconds for a total of 10 puffs. This will be followed by a 2.5 hour abstinence period. They will then use the tobacco cigarette as they wish (ad-lib use) for 4 hours.
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|---|---|---|
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Respiratory, thoracic and mediastinal disorders
cough
|
12.5%
2/16 • Number of events 2 • Up to 1 month.
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6.2%
1/16 • Number of events 1 • Up to 1 month.
|
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Ear and labyrinth disorders
vertigo
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6.2%
1/16 • Number of events 1 • Up to 1 month.
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0.00%
0/16 • Up to 1 month.
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Additional Information
Dr. Neal Benowitz
University of California San Francisco
Phone: 628-206-8324
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place