Trial Outcomes & Findings for The Interaction of Flavor With Nicotine Form in Adult Smokers (NCT NCT04262817)
NCT ID: NCT04262817
Last Updated: 2023-05-26
Results Overview
Following each puff, each participant was assessed to determine if they liked/disliked the overall e-cigarette experience using the Labeled Hedonic Scale (LHS), a bipolar category-ratio scale with 5 symmetrical semantic labels positioned on the scale per their semantic magnitude that ranges from -100 (Most Disliked) to 100 (Most Liked) with "Neither Liked nor Disliked" at the midpoint.
COMPLETED
PHASE1
20 participants
up to 3 weeks
2023-05-26
Participant Flow
20 participants were initially enrolled but only 16 took part in the actual study.
Participant milestones
| Measure |
Overall Participants
The overall sample of participants that were enrolled in the study.
10 participants received E-cigarette nicotine FIRST, E-cigarette experimental flavor SECOND.
6 participants received E-cigarette experimental flavor FIRST, E-cigarette nicotine SECOND.
|
|---|---|
|
Overall Study
STARTED
|
16
|
|
Overall Study
Freebase Tobacco Flavor Completed
|
16
|
|
Overall Study
Freebase Menthol Flavor Completed
|
16
|
|
Overall Study
Nicotine Salt Tobacco Flavor Completed
|
16
|
|
Overall Study
Nicotine Salt Menthol Flavor Completed
|
16
|
|
Overall Study
COMPLETED
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Interaction of Flavor With Nicotine Form in Adult Smokers
Baseline characteristics by cohort
| Measure |
Overall Participants
n=16 Participants
As a crossover study with randomized order, presented are the participant characteristics of all participants that were enrolled and participated in the study.
|
|---|---|
|
Age, Continuous
|
39.3 years
STANDARD_DEVIATION 9.1 • n=93 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic White
|
9 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic Black
|
4 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Biracial/Other
|
1 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
2 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=93 Participants
|
|
Education Level
GED or equivalent
|
3 Participants
n=93 Participants
|
|
Education Level
High School Graduate
|
2 Participants
n=93 Participants
|
|
Education Level
Some college, no degree
|
4 Participants
n=93 Participants
|
|
Education Level
Associate Degree
|
4 Participants
n=93 Participants
|
|
Education Level
Bachelor's Degree
|
3 Participants
n=93 Participants
|
|
Past Year Income
$0-35,000
|
9 Participants
n=93 Participants
|
|
Past Year Income
$35,001-50,000
|
1 Participants
n=93 Participants
|
|
Past Year Income
$50,001-75,000
|
2 Participants
n=93 Participants
|
|
Past Year Income
$75,001-100,000
|
3 Participants
n=93 Participants
|
|
Past Year Income
$100,001 or more
|
1 Participants
n=93 Participants
|
|
Age first tried e-cigarette
|
32.1 years
STANDARD_DEVIATION 9.5 • n=93 Participants
|
|
Days used of e-cigarettes in past 28 days
|
14.9 days
STANDARD_DEVIATION 10.7 • n=93 Participants
|
|
e-cigarette dependence
|
1.5 units on a scale
STANDARD_DEVIATION 1.1 • n=93 Participants
|
|
Age first smoked whole cigarette
|
16.1 years
STANDARD_DEVIATION 4.4 • n=93 Participants
|
|
Cigarettes smoked per day
|
12.9 cigarettes
STANDARD_DEVIATION 5.0 • n=93 Participants
|
|
cigarette dependence
|
2.4 units on a scale
STANDARD_DEVIATION 0.7 • n=93 Participants
|
PRIMARY outcome
Timeframe: up to 3 weeksPopulation: Participants that enrolled and participated in the overall study.
Following each puff, each participant was assessed to determine if they liked/disliked the overall e-cigarette experience using the Labeled Hedonic Scale (LHS), a bipolar category-ratio scale with 5 symmetrical semantic labels positioned on the scale per their semantic magnitude that ranges from -100 (Most Disliked) to 100 (Most Liked) with "Neither Liked nor Disliked" at the midpoint.
Outcome measures
| Measure |
Overall Participants
n=16 Participants
As a crossover study with randomized order, presented are the participant characteristics of all participants that were enrolled and participated in the study.
|
|---|---|
|
Changes in Liking of E-cigarette Overall
Nicotine Salt
|
14.2 score on a scale
Standard Error 6.0
|
|
Changes in Liking of E-cigarette Overall
Freebase Nicotine
|
5.3 score on a scale
Standard Error 6.6
|
|
Changes in Liking of E-cigarette Overall
Menthol Flavor
|
11.9 score on a scale
Standard Error 7.0
|
|
Changes in Liking of E-cigarette Overall
Tobacco Flavor
|
2.2 score on a scale
Standard Error 6.2
|
PRIMARY outcome
Timeframe: up to 3 weeksPopulation: Participants that enrolled and participated in the overall study.
Following each puff, each participant was assessed to determine if they liked/disliked the flavors in the e-cigarette experience using the Labeled Hedonic Scale (LHS), a bipolar category-ratio scale with 5 symmetrical semantic labels positioned on the scale per their semantic magnitude that ranges from -100 (Most Disliked) to 100 (Most Liked) with "Neither Liked nor Disliked" at the midpoint.
Outcome measures
| Measure |
Overall Participants
n=16 Participants
As a crossover study with randomized order, presented are the participant characteristics of all participants that were enrolled and participated in the study.
|
|---|---|
|
Changes in Liking of E-cigarette Flavor
Tobacco Flavor
|
2.2 score on a scale
Standard Error 6.2
|
|
Changes in Liking of E-cigarette Flavor
Nicotine Salt
|
4.1 score on a scale
Standard Error 4.6
|
|
Changes in Liking of E-cigarette Flavor
Freebase Nicotine
|
0.0 score on a scale
Standard Error 6.5
|
|
Changes in Liking of E-cigarette Flavor
Menthol Flavor
|
6.3 score on a scale
Standard Error 5.7
|
SECONDARY outcome
Timeframe: up to 3 weeksPopulation: Participants that enrolled and participated in the overall study.
Immediately following each puff, participants rated the sensory effects they experienced (harshness/irritation, coolness, sweetness) "right now" on the general version of the Labeled Magnitude Scale (gLMS). The gLMS is a category ratio scale with 7 semantic labels: "no sensation", "barely detectable", "weak", "moderate", "strong", "very strong", and "strongest imaginable", positioned quasi-logarithmically per their empirically determined semantic magnitudes, with responses coded on a 0-100 scale. The scores have been log transformed with responses coded on a 0-4.6 natural log transformed scale. The higher the score, the higher the intensity for the outcome (i.e., irritation, sweetness, coolness).
Outcome measures
| Measure |
Overall Participants
n=16 Participants
As a crossover study with randomized order, presented are the participant characteristics of all participants that were enrolled and participated in the study.
|
|---|---|
|
gLMS: Sweetness
Nicotine Salt
|
2.1 score on a scale
Standard Error 0.3
|
|
gLMS: Sweetness
Freebase Nicotine
|
2.0 score on a scale
Standard Error 0.2
|
|
gLMS: Sweetness
Menthol Flavor
|
2.1 score on a scale
Standard Error 0.2
|
|
gLMS: Sweetness
Tobacco Flavor
|
2.0 score on a scale
Standard Error 0.3
|
SECONDARY outcome
Timeframe: up to 3 weeksPopulation: Participants that enrolled and participated in the overall study.
Immediately following each puff, participants rated the sensory effects they experienced (harshness/irritation, coolness, sweetness) "right now" on the general version of the Labeled Magnitude Scale (gLMS). The gLMS is a category ratio scale with 7 semantic labels: "no sensation", "barely detectable", "weak", "moderate", "strong", "very strong", and "strongest imaginable", positioned quasi-logarithmically per their empirically determined semantic magnitudes, with responses coded on a 0-100 scale. The scores have been log transformed with responses coded on a 0-4.6 natural log transformed scale. The higher the score, the higher the intensity for the outcome (i.e., irritation, sweetness, coolness).
Outcome measures
| Measure |
Overall Participants
n=16 Participants
As a crossover study with randomized order, presented are the participant characteristics of all participants that were enrolled and participated in the study.
|
|---|---|
|
gLMS: Coolness
Nicotine Salt
|
1.9 score on a scale
Standard Error 0.2
|
|
gLMS: Coolness
Freebase Nicotine
|
1.7 score on a scale
Standard Error 0.2
|
|
gLMS: Coolness
Menthol Flavor
|
2.0 score on a scale
Standard Error 0.2
|
|
gLMS: Coolness
Tobacco Flavor
|
1.6 score on a scale
Standard Error 0.3
|
SECONDARY outcome
Timeframe: up to 3 weeksPopulation: Participants that enrolled and participated in the overall study.
Immediately following each puff, participants rated the sensory effects they experienced (harshness/irritation, coolness, sweetness) "right now" on the general version of the Labeled Magnitude Scale (gLMS). The gLMS is a category ratio scale with 7 semantic labels: "no sensation", "barely detectable", "weak", "moderate", "strong", "very strong", and "strongest imaginable", positioned quasi-logarithmically per their empirically determined semantic magnitudes, with responses coded on a 0-100 scale. The scores have been log transformed with responses coded on a 0-4.6 natural log transformed scale. The higher the score, the higher the intensity for the outcome (i.e., irritation, sweetness, coolness).
Outcome measures
| Measure |
Overall Participants
n=16 Participants
As a crossover study with randomized order, presented are the participant characteristics of all participants that were enrolled and participated in the study.
|
|---|---|
|
gLMS: Irritation
Nicotine Salt
|
2.1 score on a scale
Standard Error 0.3
|
|
gLMS: Irritation
Freebase Nicotine
|
2.6 score on a scale
Standard Error 0.2
|
|
gLMS: Irritation
Menthol Flavor
|
2.1 score on a scale
Standard Error 0.3
|
|
gLMS: Irritation
Tobacco Flavor
|
2.5 score on a scale
Standard Error 0.2
|
SECONDARY outcome
Timeframe: up to 3 weeksPopulation: Participants that enrolled and participated in the overall study.
The number of puffs on each device were counter per participant across each level of the study design. The scores have been log transformed.
Outcome measures
| Measure |
Overall Participants
n=16 Participants
As a crossover study with randomized order, presented are the participant characteristics of all participants that were enrolled and participated in the study.
|
|---|---|
|
Number of Puffs
Nicotine Salt
|
2.1 number of puffs (log transformed)
Standard Error 0.2
|
|
Number of Puffs
Freebase Nicotine
|
1.7 number of puffs (log transformed)
Standard Error 0.2
|
|
Number of Puffs
Menthol Flavor
|
2.1 number of puffs (log transformed)
Standard Error 0.2
|
|
Number of Puffs
Tobacco Flavor
|
1.8 number of puffs (log transformed)
Standard Error 0.2
|
Adverse Events
Nicotine Form: Nicotine Salt
Nicotine Form: Freebase Nicotine
E-cigarette Experimental Flavor: Menthol
E-cigarette Experimental Flavor: Tobacco
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place