Trial Outcomes & Findings for A Bioavailability Study of Nicotine Delivered by an Electronic Vapour Product (NCT NCT02032212)
NCT ID: NCT02032212
Last Updated: 2025-09-10
Results Overview
Maximum plasma nicotine concentration (Cmax)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
12 participants
Primary outcome timeframe
1, 2, 3, 4, 5, 6, 7, 8, 10, 13, 15, 30, 45, 60 minutes, 2, 4, 6, 8, 12 and 21 hours
Results posted on
2025-09-10
Participant Flow
Participant milestones
| Measure |
Sequence 1
Subjects in this arm used the unflavoured EVP on Day 1, the flavoured EVP on Day 2, Nicotine inhalator on Day 3 and the conventional cigarette on Day 4.
|
Sequence 2
Subjects in this arm used the flavoured EVP on Day 1, the unflavoured EVP on Day 2, the conventional cigarette on Day 3 and the nicotine inhalator on Day 4.
|
Sequence 3
Subjects in this arm used the nicotine inhalator on Day 1, the conventional cigarette on Day 2, the unflavoured EVP on Day 3 and the flavoured EVP on Day 4.
|
Sequence 4
Subjects in this arm used the conventional cigarette on Day 1, the nicotine inhalator on Day 2, the flavoured EVP on Day 3 and the unflavoured EVP on Day 4.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
3
|
3
|
|
Overall Study
COMPLETED
|
3
|
3
|
3
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Bioavailability Study of Nicotine Delivered by an Electronic Vapour Product
Baseline characteristics by cohort
| Measure |
Sequence 1
n=3 Participants
Subjects in this arm used the unflavoured EVP on Day 1, the flavoured EVP on Day 2, Nicotine inhalator on Day 3 and the conventional cigarette on Day 4.
|
Sequence 2
n=3 Participants
Subjects in this arm used the flavoured EVP on Day 1, the unflavoured EVP on Day 2, the conventional cigarette on Day 3 and the Nicotine inhalator on Day 4.
|
Sequence 3
n=3 Participants
Subjects in this arm used the Nicotine inhalator on Day 1 and the conventional cigarette on Day 2, the unflavoured EVP on Day 3 and the flavoured EVP on Day 4.
|
Sequence 4
n=3 Participants
Subjects in this arm used the conventional cigarette on Day 1, the Nicotine inhalator on Day 2, the flavoured EVP on Day 3, the unflavoured EVP on Day 4.
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
12 Participants
n=31 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
12 Participants
n=31 Participants
|
|
Region of Enrollment
United Kingdom
|
3 participants
n=99 Participants
|
3 participants
n=107 Participants
|
3 participants
n=206 Participants
|
3 participants
n=7 Participants
|
12 participants
n=31 Participants
|
PRIMARY outcome
Timeframe: 1, 2, 3, 4, 5, 6, 7, 8, 10, 13, 15, 30, 45, 60 minutes, 2, 4, 6, 8, 12 and 21 hoursMaximum plasma nicotine concentration (Cmax)
Outcome measures
| Measure |
EVP Unflavoured
n=12 Participants
Unflavoured e-vapour product
|
EVP Flavoured
n=12 Participants
Flavoured e-vapour product
|
Nicotine Inhalator
n=12 Participants
Nicotine inhalator 15mg
|
Conventional Cigarette
n=12 Participants
Conventional cigarette (commercially available)
|
|---|---|---|---|---|
|
Nicotine Plasma Concentration
|
3.6 ng/ml
Geometric Coefficient of Variation 33.9
|
2.5 ng/ml
Geometric Coefficient of Variation 41.6
|
2.5 ng/ml
Geometric Coefficient of Variation 45.2
|
21.2 ng/ml
Geometric Coefficient of Variation 43.1
|
PRIMARY outcome
Timeframe: 1, 2, 3, 4, 5, 6, 7, 8, 10, 13, 15, 30, 45, 60 minutes, 2, 4, 6, 8, 12 and 21 hoursOutcome measures
| Measure |
EVP Unflavoured
n=12 Participants
Unflavoured e-vapour product
|
EVP Flavoured
n=12 Participants
Flavoured e-vapour product
|
Nicotine Inhalator
n=12 Participants
Nicotine inhalator 15mg
|
Conventional Cigarette
n=12 Participants
Conventional cigarette (commercially available)
|
|---|---|---|---|---|
|
Area Under the Concentration-time Curve for Plasma Nicotine (AUCt)
|
425.3 min*ng/ml
Geometric Coefficient of Variation 31.4
|
277.2 min*ng/ml
Geometric Coefficient of Variation 33.7
|
320.6 min*ng/ml
Geometric Coefficient of Variation 47.6
|
2247.0 min*ng/ml
Geometric Coefficient of Variation 28.6
|
SECONDARY outcome
Timeframe: 25 minutesMeasured with a Smokerlyser device
Outcome measures
| Measure |
EVP Unflavoured
n=12 Participants
Unflavoured e-vapour product
|
EVP Flavoured
n=12 Participants
Flavoured e-vapour product
|
Nicotine Inhalator
n=12 Participants
Nicotine inhalator 15mg
|
Conventional Cigarette
n=12 Participants
Conventional cigarette (commercially available)
|
|---|---|---|---|---|
|
Exhaled Carbon Monoxide
|
2.5 ppm
Standard Deviation 1.0
|
2.2 ppm
Standard Deviation 0.72
|
2.3 ppm
Standard Deviation 0.78
|
14.8 ppm
Standard Deviation 3.86
|
SECONDARY outcome
Timeframe: 30 minutes after the third product useWithdrawal symptoms were evaluated with the Minnesota Nicotine Withdrawal Scale questionnaire, to which only the 15 questions of the subject's part were completed. Subjects had to rate behaviours (e.g. angry, irritable, frustrated, depressed, restless, insomnia) from 0 (none) to 4 (severe). A higher score means more severe withdrawal symptoms. Scores range from a minimum of 0 to a maximum of 60.
Outcome measures
| Measure |
EVP Unflavoured
n=12 Participants
Unflavoured e-vapour product
|
EVP Flavoured
n=12 Participants
Flavoured e-vapour product
|
Nicotine Inhalator
n=12 Participants
Nicotine inhalator 15mg
|
Conventional Cigarette
n=12 Participants
Conventional cigarette (commercially available)
|
|---|---|---|---|---|
|
Nicotine Withdrawal Symptoms
|
6.40 score on a scale
Standard Deviation 6.52
|
6.80 score on a scale
Standard Deviation 7.32
|
7.50 score on a scale
Standard Deviation 7.08
|
8.10 score on a scale
Standard Deviation 8.93
|
SECONDARY outcome
Timeframe: 30 minutes after the third product useCraving was assessed with the Brief Questionnaire of Smoking Urges (QSU-Brief). Subject had to rate 10 statements, such as "I have a desire for a cigarette right now", by a number ranging from 1 (strongly disagree) to 7 (strongly agree). Scores can range from a minimum of 0 to a maximum of 70. A higher score means a stronger urge to smoke a cigarette.
Outcome measures
| Measure |
EVP Unflavoured
n=12 Participants
Unflavoured e-vapour product
|
EVP Flavoured
n=12 Participants
Flavoured e-vapour product
|
Nicotine Inhalator
n=12 Participants
Nicotine inhalator 15mg
|
Conventional Cigarette
n=12 Participants
Conventional cigarette (commercially available)
|
|---|---|---|---|---|
|
Nicotine Craving
|
24.8 score on a scale
Standard Deviation 11.5
|
25.0 score on a scale
Standard Deviation 12.9
|
25.6 score on a scale
Standard Deviation 12.0
|
22.8 score on a scale
Standard Deviation 14.2
|
Adverse Events
EVP Unflavoured
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
EVP Flavoured
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Nicotine Inhalator
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Conventional Cigarette
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
EVP Unflavoured
n=12 participants at risk
Unflavoured e-vapour product
|
EVP Flavoured
n=12 participants at risk
Flavoured e-vapour product
|
Nicotine Inhalator
n=12 participants at risk
Nicotine inhalator 15mg
|
Conventional Cigarette
n=12 participants at risk
Conventional cigarette (commercially available)
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Glossodynia
|
0.00%
0/12 • 5 days
|
0.00%
0/12 • 5 days
|
8.3%
1/12 • Number of events 1 • 5 days
|
0.00%
0/12 • 5 days
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/12 • 5 days
|
8.3%
1/12 • Number of events 1 • 5 days
|
0.00%
0/12 • 5 days
|
0.00%
0/12 • 5 days
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.3%
1/12 • Number of events 2 • 5 days
|
8.3%
1/12 • Number of events 1 • 5 days
|
16.7%
2/12 • Number of events 5 • 5 days
|
0.00%
0/12 • 5 days
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/12 • 5 days
|
8.3%
1/12 • Number of events 1 • 5 days
|
8.3%
1/12 • Number of events 1 • 5 days
|
0.00%
0/12 • 5 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place