Trial Outcomes & Findings for Establishing the Effect of Flavor on the Addictive Potential of Electronic Cigarettes (NCT NCT03905928)
NCT ID: NCT03905928
Last Updated: 2025-06-22
Results Overview
Functional magnetic resonance imaging (fMRI) will be used to measure blood oxygen-level dependent (BOLD) signal in response to tobacco vs. strawberry-vanilla ECIG flavors at baseline. The means reported are the average percentage of BOLD signal change between the fMRI task odor conditions (tobacco vs. strawberry) identified using a whole-brain one-sample t-test with FSL software. Positive values indicate stronger BOLD signal during tobacco odor cues and negative values indicate stronger BOLD signal during strawberry odor cues.
COMPLETED
NA
19 participants
Baseline
2025-06-22
Participant Flow
Participant milestones
| Measure |
18mg/ml Tobacco Flavor ECIG
Participants will be provided with an ECIG containing 18mg/ml nicotine concentration and a tobacco flavor.
|
0mg/ml Tobacco Flavor ECIG
Participants will be provided with an ECIG containing 0mg/ml nicotine concentration and a tobacco flavor.
|
18mg/ml Strawberry Vanilla Flavor ECIG
Participants will be provided with an ECIG containing 18mg/ml nicotine concentration and a strawberry vanilla flavor.
|
0mg/ml Strawberry Vanilla Flavor ECIG
Participants will be provided with an ECIG containing 0mg/ml nicotine concentration and a strawberry vanilla flavor.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
3
|
5
|
5
|
|
Overall Study
COMPLETED
|
5
|
3
|
3
|
4
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
2
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Establishing the Effect of Flavor on the Addictive Potential of Electronic Cigarettes
Baseline characteristics by cohort
| Measure |
18mg/ml Tobacco Flavor ECIG
n=6 Participants
Participants will be provided with an ECIG containing 18mg/ml nicotine concentration and a tobacco flavor.
|
0mg/ml Tobacco Flavor ECIG
n=3 Participants
Participants will be provided with an ECIG containing 0mg/ml nicotine concentration and a tobacco flavor.
|
18mg/ml Strawberry Vanilla Flavor ECIG
n=5 Participants
Participants will be provided with an ECIG containing 18mg/ml nicotine concentration and a strawberry vanilla flavor.
|
0mg/ml Strawberry Vanilla Flavor ECIG
n=5 Participants
Participants will be provided with an ECIG containing 0mg/ml nicotine concentration and a strawberry vanilla flavor.
|
Total
n=19 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
49.00 years
STANDARD_DEVIATION 9.30 • n=93 Participants
|
41.67 years
STANDARD_DEVIATION 13.05 • n=4 Participants
|
45.60 years
STANDARD_DEVIATION 10.46 • n=27 Participants
|
44.40 years
STANDARD_DEVIATION 8.99 • n=483 Participants
|
46.00 years
STANDARD_DEVIATION 9.60 • n=36 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
13 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
6 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
18 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
18 Participants
n=36 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: BaselinePopulation: For this within-subjects comparison of laboratory task conditions, we included all 19 participants who completed a functional MRI scan at baseline. All assigned groups were combined since group assignment was not a variable of interest for this aim.
Functional magnetic resonance imaging (fMRI) will be used to measure blood oxygen-level dependent (BOLD) signal in response to tobacco vs. strawberry-vanilla ECIG flavors at baseline. The means reported are the average percentage of BOLD signal change between the fMRI task odor conditions (tobacco vs. strawberry) identified using a whole-brain one-sample t-test with FSL software. Positive values indicate stronger BOLD signal during tobacco odor cues and negative values indicate stronger BOLD signal during strawberry odor cues.
Outcome measures
| Measure |
Total Baseline Sample
n=19 Participants
The total baseline sample includes the 19 participants who completed a functional MRI scan at baseline and were randomized to a condition, regardless of study completion.
|
0 mg/ml Nicotine Concentration E-cigarettes
This group includes participants randomized to the 0 mg/ml nicotine concentration e-cigarettes, regardless of flavor.
|
18mg/ml Strawberry Vanilla Flavor ECIG
Participants will be provided with an ECIG containing 15mg/ml nicotine concentration and a strawberry vanilla flavor.
|
0mg/ml Strawberry Vanilla Flavor ECIG
Participants will be provided with an ECIG containing 0mg/ml nicotine concentration and a strawberry vanilla flavor.
|
|---|---|---|---|---|
|
Baseline Neural Flavor Cue-reactivity at Baseline
Right insula
|
0.08 percentage of BOLD signal change
Standard Deviation 0.07
|
—
|
—
|
—
|
|
Baseline Neural Flavor Cue-reactivity at Baseline
Left amygdala
|
0.23 percentage of BOLD signal change
Standard Deviation 0.20
|
—
|
—
|
—
|
|
Baseline Neural Flavor Cue-reactivity at Baseline
Ventral tegmental area
|
0.10 percentage of BOLD signal change
Standard Deviation 0.07
|
—
|
—
|
—
|
|
Baseline Neural Flavor Cue-reactivity at Baseline
Left ventral cerebellum
|
0.14 percentage of BOLD signal change
Standard Deviation 0.12
|
—
|
—
|
—
|
|
Baseline Neural Flavor Cue-reactivity at Baseline
Right dorsal cerebellum
|
0.13 percentage of BOLD signal change
Standard Deviation 0.16
|
—
|
—
|
—
|
|
Baseline Neural Flavor Cue-reactivity at Baseline
Left dorsal cerebellum
|
0.09 percentage of BOLD signal change
Standard Deviation 0.07
|
—
|
—
|
—
|
|
Baseline Neural Flavor Cue-reactivity at Baseline
Medial prefrontal cortex
|
-0.15 percentage of BOLD signal change
Standard Deviation 0.13
|
—
|
—
|
—
|
|
Baseline Neural Flavor Cue-reactivity at Baseline
Left medial pre/postcentral gyri
|
-0.06 percentage of BOLD signal change
Standard Deviation 0.05
|
—
|
—
|
—
|
|
Baseline Neural Flavor Cue-reactivity at Baseline
Left lateral pre/postcentral gyri
|
-0.07 percentage of BOLD signal change
Standard Deviation 0.07
|
—
|
—
|
—
|
|
Baseline Neural Flavor Cue-reactivity at Baseline
Precuneous
|
-0.07 percentage of BOLD signal change
Standard Deviation 0.06
|
—
|
—
|
—
|
|
Baseline Neural Flavor Cue-reactivity at Baseline
Right pre/postcentral gyri
|
-0.06 percentage of BOLD signal change
Standard Deviation 0.04
|
—
|
—
|
—
|
|
Baseline Neural Flavor Cue-reactivity at Baseline
Bilateral superior frontal gyrus
|
-0.07 percentage of BOLD signal change
Standard Deviation 0.05
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline to 4-weeksPopulation: This analysis includes 15 participants who completed baseline and post-intervention functional MRI scans. Groups assigned to nicotine vs. no nicotine were compared and flavor sub-groups within the nicotine groups (tobacco vs. strawberry) were combined, since flavor was not a variable of interest for this aim.
Functional magnetic resonance imaging (fMRI) will be used to measure changes in blood oxygen-level dependent (BOLD) signal for the tobacco\>strawberry contrast across 18 mg/ml vs. 0 mg/ml nicotine concentration groups from baseline to 4-weeks post-randomization using a whole-brain repeated measures ANOVA with FSL software. The means reported are the difference (4-week post-intervention - baseline) of the average percentage of BOLD signal change between the fMRI task odor conditions (tobacco vs. strawberry). Positive values indicate increases in tobacco\>strawberry BOLD signal and negative values indicate decreases in tobacco\> strawberry BOLD signal.
Outcome measures
| Measure |
Total Baseline Sample
n=8 Participants
The total baseline sample includes the 19 participants who completed a functional MRI scan at baseline and were randomized to a condition, regardless of study completion.
|
0 mg/ml Nicotine Concentration E-cigarettes
n=7 Participants
This group includes participants randomized to the 0 mg/ml nicotine concentration e-cigarettes, regardless of flavor.
|
18mg/ml Strawberry Vanilla Flavor ECIG
Participants will be provided with an ECIG containing 15mg/ml nicotine concentration and a strawberry vanilla flavor.
|
0mg/ml Strawberry Vanilla Flavor ECIG
Participants will be provided with an ECIG containing 0mg/ml nicotine concentration and a strawberry vanilla flavor.
|
|---|---|---|---|---|
|
Changes in Neural Flavor Cue-reactivity Across Nicotine Groups
Left insula
|
0.18 % BOLD signal change difference score
Standard Deviation 0.17
|
-0.12 % BOLD signal change difference score
Standard Deviation 0.15
|
—
|
—
|
|
Changes in Neural Flavor Cue-reactivity Across Nicotine Groups
Medial prefrontal cortex
|
0.21 % BOLD signal change difference score
Standard Deviation 0.14
|
-0.21 % BOLD signal change difference score
Standard Deviation 0.29
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline to 4-weeksPopulation: This analysis includes 15 participants who completed baseline and post-intervention functional MRI scans. Groups assigned to tobacco vs. strawberry were compared and nicotine sub-groups within the flavor groups (nicotine vs. no nicotine) were combined, since nicotine was not a variable of interest for this aim.
Functional magnetic resonance imaging (fMRI) will be used to measure changes in blood oxygen-level dependent (BOLD) signal for the tobacco \> strawberry contrast across flavor groups (tobacco vs. strawberry) from baseline to 4-weeks post-randomization. The means reported are the difference (4-week post-intervention - baseline) of the average percentage of BOLD signal change between the fMRI task odor condition (tobacco vs. strawberry) identified using a whole-brain repeated measures ANOVA with FSL software. Positive values indicate increases in tobacco\>strawberry BOLD signal and negative values indicate decreases in tobacco\> strawberry BOLD signal.
Outcome measures
| Measure |
Total Baseline Sample
n=8 Participants
The total baseline sample includes the 19 participants who completed a functional MRI scan at baseline and were randomized to a condition, regardless of study completion.
|
0 mg/ml Nicotine Concentration E-cigarettes
n=7 Participants
This group includes participants randomized to the 0 mg/ml nicotine concentration e-cigarettes, regardless of flavor.
|
18mg/ml Strawberry Vanilla Flavor ECIG
Participants will be provided with an ECIG containing 15mg/ml nicotine concentration and a strawberry vanilla flavor.
|
0mg/ml Strawberry Vanilla Flavor ECIG
Participants will be provided with an ECIG containing 0mg/ml nicotine concentration and a strawberry vanilla flavor.
|
|---|---|---|---|---|
|
Changes in Neural Flavor Cue-reactivity Across Flavor Groups
Right prefrontal cortex
|
-0.07 % BOLD signal change difference score
Standard Deviation 0.03
|
0.05 % BOLD signal change difference score
Standard Deviation 0.05
|
—
|
—
|
|
Changes in Neural Flavor Cue-reactivity Across Flavor Groups
Thalamus and right insula
|
-0.05 % BOLD signal change difference score
Standard Deviation 0.01
|
0.06 % BOLD signal change difference score
Standard Deviation 0.06
|
—
|
—
|
SECONDARY outcome
Timeframe: 2-weeks post-randomization to 4-weeks post-randomizationPopulation: This analysis included 14 participants who completed the 2-week check-in and 4-week post-intervention visits and completed the PSECDI.
Changes in self-reported ECIG dependence will be measured using the Penn State Electronic Cigarette Dependence Index (PSECDI). Total scores on this 10-item measure range from 0 to 20, with higher scores indicating higher levels of e-cigarette dependence. The means reported here are the week 4 - week 2 difference scores of the total dependence score. Positive means indicate increases in e-cigarette dependence, while negative means indicated decreases in e-cigarette dependence.
Outcome measures
| Measure |
Total Baseline Sample
n=5 Participants
The total baseline sample includes the 19 participants who completed a functional MRI scan at baseline and were randomized to a condition, regardless of study completion.
|
0 mg/ml Nicotine Concentration E-cigarettes
n=3 Participants
This group includes participants randomized to the 0 mg/ml nicotine concentration e-cigarettes, regardless of flavor.
|
18mg/ml Strawberry Vanilla Flavor ECIG
n=2 Participants
Participants will be provided with an ECIG containing 15mg/ml nicotine concentration and a strawberry vanilla flavor.
|
0mg/ml Strawberry Vanilla Flavor ECIG
n=4 Participants
Participants will be provided with an ECIG containing 0mg/ml nicotine concentration and a strawberry vanilla flavor.
|
|---|---|---|---|---|
|
ECIG Dependence
|
-1.60 units on a scale
Standard Deviation 2.07
|
-1.33 units on a scale
Standard Deviation 3.21
|
-3.00 units on a scale
Standard Deviation 4.24
|
0.00 units on a scale
Standard Deviation 1.41
|
SECONDARY outcome
Timeframe: 2-weeks to 4-weeksPopulation: This analysis includes 8 participants who completed the e-cigarette evaluation scale at the 2-week check-in and 4-week post-intervention visit. Only participants who reported using the study e-cigarette since the last study visit completed the evaluation scale.
Changes in subjective experiences of ECIG use related to liking and satisfaction will be collected via a self-report survey. The survey consists of 21-items (7-reversed scored) with response options on a 7-point likert scale and total scores ranging from 0 to 126. Higher scores indicate more ECIG liking and satisfaction. The means reported here are the difference of the total scores at week 4 - week 2, with positive means indicating increases in e-cigarette liking and negative means indicating decreases in liking. Note that standard deviation cannot be reported for groups with only one participant.
Outcome measures
| Measure |
Total Baseline Sample
n=3 Participants
The total baseline sample includes the 19 participants who completed a functional MRI scan at baseline and were randomized to a condition, regardless of study completion.
|
0 mg/ml Nicotine Concentration E-cigarettes
n=1 Participants
This group includes participants randomized to the 0 mg/ml nicotine concentration e-cigarettes, regardless of flavor.
|
18mg/ml Strawberry Vanilla Flavor ECIG
n=1 Participants
Participants will be provided with an ECIG containing 15mg/ml nicotine concentration and a strawberry vanilla flavor.
|
0mg/ml Strawberry Vanilla Flavor ECIG
n=3 Participants
Participants will be provided with an ECIG containing 0mg/ml nicotine concentration and a strawberry vanilla flavor.
|
|---|---|---|---|---|
|
ECIG Liking and Satisfaction
|
2.33 units on a scale
Standard Deviation 7.57
|
-21.00 units on a scale
Standard Deviation 0.00
|
16 units on a scale
Standard Deviation 0.00
|
-5.00 units on a scale
Standard Deviation 4.36
|
SECONDARY outcome
Timeframe: Baseline to 4-weeks post-randomizationPopulation: This analysis includes 15 participants that completed the craving scales before the functional MRI scans at baseline and at the post-intervention visits.
Changes in self-reported craving to smoke/vape were measured with 3 questions on amount, intensity, and self-control using visual analogue scales ranging from 0 to 10 prior to completing the functional MRI scan. Total scores range from 0 to 30 and higher scores indicate more craving. The means reported here are week 4 post-intervention - baseline difference scores of the total craving score. Positive means indicate increases in craving, while negative means indicate decreases in craving.
Outcome measures
| Measure |
Total Baseline Sample
n=5 Participants
The total baseline sample includes the 19 participants who completed a functional MRI scan at baseline and were randomized to a condition, regardless of study completion.
|
0 mg/ml Nicotine Concentration E-cigarettes
n=3 Participants
This group includes participants randomized to the 0 mg/ml nicotine concentration e-cigarettes, regardless of flavor.
|
18mg/ml Strawberry Vanilla Flavor ECIG
n=3 Participants
Participants will be provided with an ECIG containing 15mg/ml nicotine concentration and a strawberry vanilla flavor.
|
0mg/ml Strawberry Vanilla Flavor ECIG
n=4 Participants
Participants will be provided with an ECIG containing 0mg/ml nicotine concentration and a strawberry vanilla flavor.
|
|---|---|---|---|---|
|
Craving to Smoke/Vape
|
3.00 units on a scale
Standard Deviation 5.43
|
3.00 units on a scale
Standard Deviation 5.43
|
-11.00 units on a scale
Standard Deviation 2.65
|
1.50 units on a scale
Standard Deviation 4.43
|
Adverse Events
18mg/ml Tobacco Flavor ECIG
0mg/ml Tobacco Flavor ECIG
18mg/ml Strawberry Vanilla Flavor ECIG
0mg/ml Strawberry Vanilla Flavor ECIG
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
18mg/ml Tobacco Flavor ECIG
n=6 participants at risk
Participants will be provided with an ECIG containing 18mg/ml nicotine concentration and a tobacco flavor.
|
0mg/ml Tobacco Flavor ECIG
n=3 participants at risk
Participants will be provided with an ECIG containing 0mg/ml nicotine concentration and a tobacco flavor.
|
18mg/ml Strawberry Vanilla Flavor ECIG
n=5 participants at risk
Participants will be provided with an ECIG containing 18mg/ml nicotine concentration and a strawberry vanilla flavor.
|
0mg/ml Strawberry Vanilla Flavor ECIG
n=5 participants at risk
Participants will be provided with an ECIG containing 0mg/ml nicotine concentration and a strawberry vanilla flavor.
|
|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/6 • 4 weeks
|
0.00%
0/3 • 4 weeks
|
0.00%
0/5 • 4 weeks
|
20.0%
1/5 • Number of events 1 • 4 weeks
|
|
Surgical and medical procedures
Procedure
|
0.00%
0/6 • 4 weeks
|
0.00%
0/3 • 4 weeks
|
0.00%
0/5 • 4 weeks
|
20.0%
1/5 • Number of events 1 • 4 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Flu-like symptoms
|
0.00%
0/6 • 4 weeks
|
0.00%
0/3 • 4 weeks
|
20.0%
1/5 • Number of events 1 • 4 weeks
|
0.00%
0/5 • 4 weeks
|
Additional Information
Andrea Hobkirk
Pennsylvania State University College of Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place