Trial Outcomes & Findings for Effects of E-cigarette Flavors on Youth TCORS 2.0 (NCT NCT03634839)
NCT ID: NCT03634839
Last Updated: 2024-08-09
Results Overview
The Labeled Hedonic Scale will be used to ask about liking and wanting of the e-cigarette (one item Visual Analog Scale with ratings ranging from "most disliked sensation imaginable" to "most liked sensation imaginable" with higher values indicating greater liking). Specific scale semantic structure and corresponding values: most disliked imaginable=-100, dislike extremely=-62.9, dislike very much=-41.6, dislike moderately=-17.6, dislike slightly=-5.9, neutral=0, like slightly=6.3, like moderately=17.8, like very much=44.4, like extremely=65.7, most liked imaginable=100.
COMPLETED
PHASE1
42 participants
Following administration of e-cigarette condition 1 (+10 minutes), following administration of e-cigarette condition 2 (+40)
2024-08-09
Participant Flow
84 young adults (18-20 years) were screened for eligibility between November 7, 2022 and June 12, 2023 through Snapchat and referrals from previous participants.
A total of 40 participants completed the study. Specifically, 49 out of 84 participants were randomized, but 7 did not show up and 2 withdrew. Of the 35 who were not randomized, 18 did not meet inclusion criteria and 17 did not show up.
Participant milestones
| Measure |
Sweet Non-menthol Then Sweet Menthol, Each With Nicotine 36mg/ml
Participants attended a one-time, two-hour laboratory session with two exposures to flavored nicotine-containing e-liquids in a randomized order. They first received Durasmoke watermelon (50:50 PG/VG base) e-liquid. After a 30-minute break, they then received Durasmoke watermelon-menthol (50:50 PG/VG base) e-liquid, each with a nicotine salt concentration of 36 mg/mL.
Flavoring Agents: Flavor of e-liquid - sweet or tobacco
Nicotine: Nicotine level (36 mg/ml)
|
Sweet Menthol Then Sweet Non-menthol, Each With Nicotine 36mg/ml
Participants attended a one-time, two-hour laboratory session with two exposures to flavored nicotine-containing e-liquids in a randomized order. They first received Durasmoke watermelon-menthol (50:50 PG/VG base) e-liquid. After a 30-minute break, they then received Durasmoke watermelon (50:50 PG/VG base) e-liquid, each with a nicotine salt concentration of 36 mg/mL.
Flavoring Agents: Flavor of e-liquid - sweet or tobacco
Nicotine: Nicotine level (36 mg/ml)
|
|---|---|---|
|
First Intervention (2 Hours)
STARTED
|
20
|
22
|
|
First Intervention (2 Hours)
COMPLETED
|
20
|
20
|
|
First Intervention (2 Hours)
NOT COMPLETED
|
0
|
2
|
|
30 Minutes Break
STARTED
|
20
|
20
|
|
30 Minutes Break
COMPLETED
|
20
|
20
|
|
30 Minutes Break
NOT COMPLETED
|
0
|
0
|
|
Second Intervention (2 Hours)
STARTED
|
20
|
20
|
|
Second Intervention (2 Hours)
COMPLETED
|
20
|
20
|
|
Second Intervention (2 Hours)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Sweet Non-menthol Then Sweet Menthol, Each With Nicotine 36mg/ml
Participants attended a one-time, two-hour laboratory session with two exposures to flavored nicotine-containing e-liquids in a randomized order. They first received Durasmoke watermelon (50:50 PG/VG base) e-liquid. After a 30-minute break, they then received Durasmoke watermelon-menthol (50:50 PG/VG base) e-liquid, each with a nicotine salt concentration of 36 mg/mL.
Flavoring Agents: Flavor of e-liquid - sweet or tobacco
Nicotine: Nicotine level (36 mg/ml)
|
Sweet Menthol Then Sweet Non-menthol, Each With Nicotine 36mg/ml
Participants attended a one-time, two-hour laboratory session with two exposures to flavored nicotine-containing e-liquids in a randomized order. They first received Durasmoke watermelon-menthol (50:50 PG/VG base) e-liquid. After a 30-minute break, they then received Durasmoke watermelon (50:50 PG/VG base) e-liquid, each with a nicotine salt concentration of 36 mg/mL.
Flavoring Agents: Flavor of e-liquid - sweet or tobacco
Nicotine: Nicotine level (36 mg/ml)
|
|---|---|---|
|
First Intervention (2 Hours)
Adverse Event
|
0
|
2
|
Baseline Characteristics
Effects of E-cigarette Flavors on Youth TCORS 2.0
Baseline characteristics by cohort
| Measure |
Sweet Non-menthol Then Sweet Menthol, Each With Nicotine 36mg/ml
n=20 Participants
Participants attended a one-time, two-hour laboratory session with two exposures to flavored nicotine-containing e-liquids in a randomized order. They first received Durasmoke watermelon (50:50 PG/VG base) e-liquid. After a 30-minute break, they then received Durasmoke watermelon-menthol (50:50 PG/VG base) e-liquid, each with a nicotine salt concentration of 36 mg/mL.
Flavoring Agents: Flavor of e-liquid - sweet or tobacco
Nicotine: Nicotine level (36 mg/ml)
|
Sweet Menthol Then Sweet Non-menthol, Each With Nicotine 36mg/ml
n=22 Participants
Participants attended a one-time, two-hour laboratory session with two exposures to flavored nicotine-containing e-liquids in a randomized order. They first received Durasmoke watermelon-menthol (50:50 PG/VG base) e-liquid. After a 30-minute break, they then received Durasmoke watermelon (50:50 PG/VG base) e-liquid, each with a nicotine salt concentration of 36 mg/mL.
Flavoring Agents: Flavor of e-liquid - sweet or tobacco
Nicotine: Nicotine level (36 mg/ml)
|
Total
n=42 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Grade
Excellent (A's)
|
14 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
|
Grade
Good (B's)
|
5 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Grade
Fair (C's)
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Grade
Barely passing (D's)
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
42 Participants
n=206 Participants
|
|
Preferred e-cigarette device
Disposable pod device
|
16 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
36 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
19.0 years
STANDARD_DEVIATION 0.7 • n=99 Participants
|
19.2 years
STANDARD_DEVIATION 0.8 • n=107 Participants
|
19.1 years
STANDARD_DEVIATION 0.8 • n=206 Participants
|
|
Preferred e-cigarette device
JUUL
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Preferred e-cigarette device
Vape pen
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
29 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=99 Participants
|
22 participants
n=107 Participants
|
42 participants
n=206 Participants
|
|
Currently enrolled in a degree program
|
17 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
32 Participants
n=206 Participants
|
|
Preferred e-cigarette device
Any pod device other than a JUUL
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Preferred e-cigarette nicotine level
50-59mg/mL or 5.0-5.9%
|
14 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
|
Preferred e-cigarette nicotine level
Other concentrations
|
4 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Preferred e-cigarette nicotine level
I don't know the concentration
|
2 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Ever vaped cooling flavor
|
20 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
42 Participants
n=206 Participants
|
|
Past-month other tobacco use
|
12 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Past-month vaped THC
|
18 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
|
Vaping age of onset
|
14.8 years
STANDARD_DEVIATION 1.9 • n=99 Participants
|
15.6 years
STANDARD_DEVIATION 1.7 • n=107 Participants
|
15.2 years
STANDARD_DEVIATION 1.8 • n=206 Participants
|
|
Vaping frequency
|
6.0 days per week
STANDARD_DEVIATION 1.8 • n=99 Participants
|
6.1 days per week
STANDARD_DEVIATION 1.4 • n=107 Participants
|
6.1 days per week
STANDARD_DEVIATION 1.6 • n=206 Participants
|
PRIMARY outcome
Timeframe: Following administration of e-cigarette condition 1 (+10 minutes), following administration of e-cigarette condition 2 (+40)Population: After each of the two puff bouts, we evaluated participants' reference for the overall experience of the e-cigarette using the LHS, which is a bipolar category ratio scale that spans from -100 (most disliked) to 100 (most liked), with 'neither liked nor disliked' positioned as the midpoint. The scale labels were places along the scale based on their semantic magnitude.
The Labeled Hedonic Scale will be used to ask about liking and wanting of the e-cigarette (one item Visual Analog Scale with ratings ranging from "most disliked sensation imaginable" to "most liked sensation imaginable" with higher values indicating greater liking). Specific scale semantic structure and corresponding values: most disliked imaginable=-100, dislike extremely=-62.9, dislike very much=-41.6, dislike moderately=-17.6, dislike slightly=-5.9, neutral=0, like slightly=6.3, like moderately=17.8, like very much=44.4, like extremely=65.7, most liked imaginable=100.
Outcome measures
| Measure |
Sweet Non-menthol, Nicotine 36mg/ml
n=40 Participants
Sweet flavor non-menthol (Watermelon) with 36mg/ml Nicotine
Flavoring Agents: Flavor of e-liquid - sweet or tobacco
Nicotine: Nicotine level (36 mg/ml)
|
Sweet Menthol, Nicotine 36mg/ml
n=40 Participants
Sweet flavor with menthol (Watermelon-menthol) with 36mg/ml Nicotine
Flavoring Agents: Flavor of e-liquid - sweet or tobacco
Nicotine: Nicotine level (36 mg/ml)
|
|---|---|---|
|
Liking: Difference Score in Liking/Wanting of Each E-cigarette Condition
|
1.268 score on a scale
Standard Error 3.158
|
-3.916 score on a scale
Standard Error 3.158
|
PRIMARY outcome
Timeframe: Following administration of e-cigarette condition 1 (+10 minutes), following administration of e-cigarette condition 2 (+40)Population: To examine wanting/liking, we used subscales from the Drug Effects Questionnaire (DEQ), following the approach established in previous literature. Four items were used to measure wanting/liking effects (the average of 'I feel good e-cigarette effects', 'I want more of that e-cigarette I received', 'I feel the e-cigarette strength', and 'I like the e-cigarette effect').
Difference between e-cigarette effects for each e-cigarette condition as measured by the computerized version of the Drug Effects Questionnaire (DEQ). Participants will self-report their responses using a computer mouse to indicate where on the scale response falls. A modified version of the Drug Effects Questionnaire (DEQ) will be used in which participants rate acute responses to the e-cigarette on a 0-100mm scale from "not at all" (0mm) to "extremely" (100mm). Higher values indicate stronger reinforcing efficacy (i.e., wanting/liking effects).
Outcome measures
| Measure |
Sweet Non-menthol, Nicotine 36mg/ml
n=40 Participants
Sweet flavor non-menthol (Watermelon) with 36mg/ml Nicotine
Flavoring Agents: Flavor of e-liquid - sweet or tobacco
Nicotine: Nicotine level (36 mg/ml)
|
Sweet Menthol, Nicotine 36mg/ml
n=40 Participants
Sweet flavor with menthol (Watermelon-menthol) with 36mg/ml Nicotine
Flavoring Agents: Flavor of e-liquid - sweet or tobacco
Nicotine: Nicotine level (36 mg/ml)
|
|---|---|---|
|
Reinforcing Efficacy: Difference Score in Drug Effects of Each E-cigarette Condition
|
37.06 score on a scale
Standard Error 3.01
|
35.18 score on a scale
Standard Error 3.01
|
PRIMARY outcome
Timeframe: At baseline (+0 minutes), Following administration of e-cigarette condition 1 (+10 minutes), following administration of e-cigarette condition 2 (+40)Difference from baseline in craving for each e-cigarette condition will be measured by the Generalized Labeled Magnitude Scale (gLMS). Participants will self-report their craving for e-cigarettes using a computer mouse to indicate where on the scale response falls. The Generalized Labeled Magnitude Scales (gLMS) are category ratio scales with seven semantic labels: "no sensation", "barely detectable", "weak", "moderate", "strong", "very strong", and "strongest imaginable", positioned quasi-logarithmically as per empirically determined semantic magnitudes on a 0-100 scale (strongest imaginable at the 100 end).
Outcome measures
| Measure |
Sweet Non-menthol, Nicotine 36mg/ml
n=40 Participants
Sweet flavor non-menthol (Watermelon) with 36mg/ml Nicotine
Flavoring Agents: Flavor of e-liquid - sweet or tobacco
Nicotine: Nicotine level (36 mg/ml)
|
Sweet Menthol, Nicotine 36mg/ml
n=40 Participants
Sweet flavor with menthol (Watermelon-menthol) with 36mg/ml Nicotine
Flavoring Agents: Flavor of e-liquid - sweet or tobacco
Nicotine: Nicotine level (36 mg/ml)
|
|---|---|---|
|
Craving: Change in Craving Score for E-cigarette
|
2.72 score on a scale
Standard Error 0.22
|
2.43 score on a scale
Standard Error 0.22
|
PRIMARY outcome
Timeframe: Following administration of e-cigarette condition 1 (+10 minutes), following administration of e-cigarette condition 2 (+40)Difference in irritation at each e-cigarette condition as measured by the computerized Generalized Labeled Magnitude Scale (gLMS). Participants will self-report their responses using a computer mouse to indicate where on the scale response falls. The Generalized Labeled Magnitude Scales (gLMS) are category ratio scales with seven semantic labels: "no sensation", "barely detectable", "weak", "moderate", "strong", "very strong", and "strongest imaginable", positioned quasi-logarithmically as per empirically determined semantic magnitudes on a 0-100 scale (strongest imaginable at the 100 end).
Outcome measures
| Measure |
Sweet Non-menthol, Nicotine 36mg/ml
n=40 Participants
Sweet flavor non-menthol (Watermelon) with 36mg/ml Nicotine
Flavoring Agents: Flavor of e-liquid - sweet or tobacco
Nicotine: Nicotine level (36 mg/ml)
|
Sweet Menthol, Nicotine 36mg/ml
n=40 Participants
Sweet flavor with menthol (Watermelon-menthol) with 36mg/ml Nicotine
Flavoring Agents: Flavor of e-liquid - sweet or tobacco
Nicotine: Nicotine level (36 mg/ml)
|
|---|---|---|
|
Irritation/Harshness: Difference Score in Irritation of Harshness of Each E-cigarette Condition
|
20.92 score on a scale
Standard Error 1.68
|
22.86 score on a scale
Standard Error 1.68
|
Adverse Events
Sweet Non-menthol With Nicotine 36mg/ml
Sweet Menthol With Nicotine 36mg/ml
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Sweet Non-menthol With Nicotine 36mg/ml
n=40 participants at risk
Participants attended a one-time, two-hour laboratory session with two exposures to flavored nicotine-containing e-liquids in a randomized order. They received Durasmoke watermelon (50:50 PG/VG base) e-liquid.
Flavoring Agents: Flavor of e-liquid - sweet or tobacco
Nicotine: Nicotine level (36 mg/ml)
|
Sweet Menthol With Nicotine 36mg/ml
n=42 participants at risk
Participants attended a one-time, two-hour laboratory session with two exposures to flavored nicotine-containing e-liquids in a randomized order. They received Durasmoke watermelon-menthol (50:50 PG/VG base) e-liquid.
Flavoring Agents: Flavor of e-liquid - sweet or tobacco
Nicotine: Nicotine level (36 mg/ml)
|
|---|---|---|
|
Product Issues
Vomiting
|
0.00%
0/40 • Two hours during a single lab session
Two mild levels of adverse events were observed. The adverse event definition aligns with the definitions on ClinicalTrials.gov.
|
4.8%
2/42 • Number of events 2 • Two hours during a single lab session
Two mild levels of adverse events were observed. The adverse event definition aligns with the definitions on ClinicalTrials.gov.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place