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Trial Outcomes & Findings for Clinical Pharmacology of Electronic Cigarettes (NCT NCT02470754)

NCT ID: NCT02470754

Last Updated: 2023-06-22

Results Overview

Maximum Plasma Nicotine Concentration (Cmax) (ng/mL)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

38 participants

Primary outcome timeframe

Inpatient Day 1, Up to 4 Hours post Nicotine Administration

Results posted on

2023-06-22

Participant Flow

Participant milestones

Participant milestones
Measure
EC Block1/TC Block 2
Participants will be randomized into one of two groups. In this group, participants will be assigned to Electronic Cigarettes only for Study Block #1, then crossover to Tobacco Cigarettes only for Study Block #2. Tobacco Cigarette: Usual brand tobacco cigarette smoked by study participant. Electronic Cigarette: Usual brand electronic cigarettes smoked by study participant.
TC Block 1/EC Block 2
Participants will be randomized into one of two groups. In this group, participants will be assigned to Tobacco Cigarettes only for Study Block #1, then crossover to Electronic Cigarettes only for Study Block #2. Tobacco Cigarette: Usual brand tobacco cigarette smoked by study participant. Electronic Cigarette: Usual brand electronic cigarettes smoked by study participant.
Overall Study
STARTED
19
19
Overall Study
COMPLETED
17
19
Overall Study
NOT COMPLETED
2
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clinical Pharmacology of Electronic Cigarettes

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Completers
n=36 Participants
all completed
Age, Continuous
35.4 years
STANDARD_DEVIATION 11.7 • n=99 Participants
Sex: Female, Male
Female
8 Participants
n=99 Participants
Sex: Female, Male
Male
28 Participants
n=99 Participants
Race/Ethnicity, Customized
Asian
2 Participants
n=99 Participants
Race/Ethnicity, Customized
Black
3 Participants
n=99 Participants
Race/Ethnicity, Customized
Latino
4 Participants
n=99 Participants
Race/Ethnicity, Customized
White
22 Participants
n=99 Participants
Race/Ethnicity, Customized
Mixed
5 Participants
n=99 Participants
Region of Enrollment
United States
36 participants
n=99 Participants
Cigarettes per day
12.9 Cigarettes per day
STANDARD_DEVIATION 6.4 • n=99 Participants
Days of EC use in past 30
22.6 Days
STANDARD_DEVIATION 7.3 • n=99 Participants
EC times per day
8.1 Sessions per day
STANDARD_DEVIATION 7.2 • n=99 Participants
E-Cigarette Use index
6.5 units on a scale
STANDARD_DEVIATION 6.5 • n=99 Participants
EC to TC use ratio
0.57 ratio
STANDARD_DEVIATION 0.56 • n=99 Participants
Fagerstrom Test for Cigarette Dependence
4.4 units on a scale
STANDARD_DEVIATION 2.0 • n=99 Participants
Time to first cigarette
≤ 5 min
6 Participants
n=99 Participants
Time to first cigarette
5-30 min
21 Participants
n=99 Participants
Time to first cigarette
30-60 min
8 Participants
n=99 Participants
Time to first cigarette
>60 min
1 Participants
n=99 Participants
Time to first vape
≤ 5 min
1 Participants
n=99 Participants
Time to first vape
5-30 min
12 Participants
n=99 Participants
Time to first vape
30-60 min
4 Participants
n=99 Participants
Time to first vape
> 60 min
19 Participants
n=99 Participants
Salivary cotinine
189 ng/mL
STANDARD_DEVIATION 92.8 • n=99 Participants
EC type
Cig-a-like
12 Participants
n=99 Participants
EC type
Fixed-power
15 Participants
n=99 Participants
EC type
Variable-power
6 Participants
n=99 Participants
EC type
Pod
3 Participants
n=99 Participants
Flavor category
Dessert/candy
8 Participants
n=99 Participants
Flavor category
Fruit
5 Participants
n=99 Participants
Flavor category
Menthol
5 Participants
n=99 Participants
Flavor category
Tobacco
18 Participants
n=99 Participants

PRIMARY outcome

Timeframe: Inpatient Day 1, Up to 4 Hours post Nicotine Administration

Population: Pod users excluded

Maximum Plasma Nicotine Concentration (Cmax) (ng/mL)

Outcome measures

Outcome measures
Measure
Electronic Cigarette
n=33 Participants
EC ARM
Combustible Cigarette
n=33 Participants
TC ARM
Standardized Session: Mean CMax
6.1 ng/mL
Standard Deviation 5.5
20.2 ng/mL
Standard Deviation 11.1

PRIMARY outcome

Timeframe: Inpatient Day 1, Up to 4 Hours post Session

Population: Pod users excluded

Time (min) when Max Plasma Nicotine Concentration was achieved

Outcome measures

Outcome measures
Measure
Electronic Cigarette
n=33 Participants
EC ARM
Combustible Cigarette
n=33 Participants
TC ARM
Standardized Session: Mean TMax
6.5 minutes
Standard Deviation 5.4
2.7 minutes
Standard Deviation 2.4

PRIMARY outcome

Timeframe: Inpatient Day 1, Up to 4 Hours post Session

Population: Pod users excluded

Plasma Nicotine area-under-the curve from 0 to 4 Hours (min\*ng/ml)

Outcome measures

Outcome measures
Measure
Electronic Cigarette
n=33 Participants
EC ARM
Combustible Cigarette
n=33 Participants
TC ARM
Standardized Session: AUC 0-240
550 min*ng/ml
Standard Deviation 438
1368 min*ng/ml
Standard Deviation 665

PRIMARY outcome

Timeframe: Inpatient Day 1, Up to 4 Hours post Session

Population: Pod Users Excluded

Estimated in dose received (in milligrams) during the Standardized Session.

Outcome measures

Outcome measures
Measure
Electronic Cigarette
n=33 Participants
EC ARM
Combustible Cigarette
n=33 Participants
TC ARM
PK-estimated Nicotine Dose
0.9 mg
Standard Deviation 0.7
2.2 mg
Standard Deviation 1.2

SECONDARY outcome

Timeframe: Inpatient Day 1, Up to 4 Hours post Session

Questionnaire for Smoking Urges Brief modified for e-cigarettes to measure urge to vape.Two factor scores and a total score were derived. Factor 1 represents the desire and intention to smoke with smoking perceived as rewarding, while Factor 2 represents an anticipation of relief from negative effect with an urgent desire to smoke.Scores range from 5 to 35 with higher scores indicating a higher level of craving.

Outcome measures

Outcome measures
Measure
Electronic Cigarette
n=33 Participants
EC ARM
Combustible Cigarette
n=33 Participants
TC ARM
Standardized Session: QSU Factor 1 (Vaping)
23.9 score on a scale
Standard Deviation 8.6
20.7 score on a scale
Standard Deviation 10.0

SECONDARY outcome

Timeframe: Inpatient Day 1, Up to 4 Hours post Session

The PANAS Scale or Positive and Negative Affect Schedule (PANAS) is a self-report questionnaire. PANAS, (Sandín et al., 1999; Watson, Clark \& Tellegen, 1988).This instrument is composed of 20 items: 10 items measuring positive affective states and 10 items measuring negative affect states.This subscale measures a person's negative emotions. Scores range from 10- 50 with higher scores indicating stronger negative feelings.

Outcome measures

Outcome measures
Measure
Electronic Cigarette
n=33 Participants
EC ARM
Combustible Cigarette
n=33 Participants
TC ARM
Standardized Session: Positive and Negative Affect Score (Negative Affect)
14.3 score on a scale
Standard Deviation 5.6
14.0 score on a scale
Standard Deviation 5.0

SECONDARY outcome

Timeframe: Inpatient Day 1, Up to 4 Hours post Session

Population: Pod Users Excluded

Minnesota Nicotine Withdrawal Scale (MNWS) is a Self-Report Scale for measuring the severity of nicotine withdrawal symptoms.The possible range of scores for the 12-Item MNWS is between 0 and 48 with higher scores indicated greater withdrawal symptom severity.

Outcome measures

Outcome measures
Measure
Electronic Cigarette
n=33 Participants
EC ARM
Combustible Cigarette
n=33 Participants
TC ARM
Standardized Session: Minnesota Nicotine Withdrawal Scale
10.8 score on a scale
Standard Deviation 7.9
9.6 score on a scale
Standard Deviation 7.4

SECONDARY outcome

Timeframe: Inpatient Day 1, Up to 4 Hours post Session

Population: Pod Users Excluded

Questionnaire for Smoking Urges Brief modified for e-cigarettes to measure urge to vape.Two factor scores and a total score were derived. Factor 1 represents the desire and intention to smoke with smoking perceived as rewarding, while Factor 2 represents an anticipation of relief from negative effect with an urgent desire to smoke. Scores range from 5 to 35 with higher scores indicating a higher level of craving.

Outcome measures

Outcome measures
Measure
Electronic Cigarette
n=33 Participants
EC ARM
Combustible Cigarette
n=33 Participants
TC ARM
Standardized Session: QSU Factor 2 (Vaping)
14.9 score on a scale
Standard Deviation 6.8
13.0 score on a scale
Standard Deviation 7.0

SECONDARY outcome

Timeframe: Inpatient Day 1, Up to 4 Hours post Session

Population: Pod Users Excluded

Questionnaire for Smoking Urges Brief measures urge to smoke.Two factor scores and a total score were derived. Factor 1 represents the desire and intention to smoke with smoking perceived as rewarding, while Factor 2 represents an anticipation of relief from negative effect with an urgent desire to smoke. Scores range from 5 to 35 with higher scores indicating a higher level of craving.

Outcome measures

Outcome measures
Measure
Electronic Cigarette
n=33 Participants
EC ARM
Combustible Cigarette
n=33 Participants
TC ARM
Standardized Session: QSU Factor 1 (Smoking)
22.9 score on a scale
Standard Deviation 9.8
24.2 score on a scale
Standard Deviation 9.9

SECONDARY outcome

Timeframe: Inpatient Day 1, Up to 4 Hours post Session

Population: Pod Users Excluded

Questionnaire for Smoking Urges Brief measures urge to smoke.Two factor scores and a total score were derived. Factor 1 represents the desire and intention to smoke with smoking perceived as rewarding, while Factor 2 represents an anticipation of relief from negative effect with an urgent desire to smoke. Scores range from 5 to 35 with higher scores indicating a higher level of craving.

Outcome measures

Outcome measures
Measure
Electronic Cigarette
n=33 Participants
EC ARM
Combustible Cigarette
n=33 Participants
TC ARM
Standardized Session: QSU Factor 2 (Smoking)
14.4 score on a scale
Standard Deviation 6.6
14.1 score on a scale
Standard Deviation 7.2

OTHER_PRE_SPECIFIED outcome

Timeframe: Inpatient Day 1, Up to 4 Hours post Session

Population: Pod Users Excluded

Estimated Time (min) to reduce the plasma nicotine concentration by half based on observed pharmacokinetics.

Outcome measures

Outcome measures
Measure
Electronic Cigarette
n=33 Participants
EC ARM
Combustible Cigarette
n=33 Participants
TC ARM
Standardized Session: Half-life
137.6 min
Standard Deviation 39.3
121.2 min
Standard Deviation 33.9

Adverse Events

Electronic Cigarette

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Combustible 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

Adverse event data not reported

Additional Information

Natalie Nardone, PhD

University of California, San Francisco

Phone: 415-514-1450

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place