Trial Outcomes & Findings for Impact of Cigarette and E-cigarette Flavors on Adult Smoking Behavior (NCT NCT04009850)
NCT ID: NCT04009850
Last Updated: 2024-03-08
Results Overview
Self-reported total number of cigarettes smoked per day (Timeline Follow Back)
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
3 participants
Primary outcome timeframe
Week 6
Results posted on
2024-03-08
Participant Flow
Participant milestones
| Measure |
Menthol E-cigarette
Adult smokers will be switched from using menthol cigarettes to non-menthol cigarettes and a menthol flavored e-cigarette
Cigarette Brand Switching: Adult smokers will be switched from smoking menthol cigarettes to non-menthol cigarettes
|
Tobacco E-cigarette
Adult smokers will be switched from using menthol cigarettes to non-menthol cigarettes and a tobacco flavored e-cigarette
E-cigarette Flavor: Adult smokers will be provided with either menthol or tobacco flavored e-cigarettes in addition to the non-menthol cigarettes
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
0
|
|
Overall Study
COMPLETED
|
3
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Impact of Cigarette and E-cigarette Flavors on Adult Smoking Behavior
Baseline characteristics by cohort
| Measure |
Menthol E-cigarette
n=3 Participants
Adult smokers will be switched from using menthol cigarettes to non-menthol cigarettes and a menthol flavored e-cigarette
Cigarette Brand Switching: Adult smokers will be switched from smoking menthol cigarettes to non-menthol cigarettes
|
Tobacco E-cigarette
Adult smokers will be switched from using menthol cigarettes to non-menthol cigarettes and a tobacco flavored e-cigarette
E-cigarette Flavor: Adult smokers will be provided with either menthol or tobacco flavored e-cigarettes in addition to the non-menthol cigarettes
|
Total
n=3 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Continuous
|
43.3 years
STANDARD_DEVIATION 13.6 • n=93 Participants
|
—
|
43.3 years
STANDARD_DEVIATION 13.6 • n=27 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=93 Participants
|
—
|
1 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=93 Participants
|
—
|
2 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
—
|
0 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=93 Participants
|
—
|
3 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
—
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
—
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
—
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
—
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=93 Participants
|
—
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=93 Participants
|
—
|
2 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
—
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
—
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=93 Participants
|
—
|
3 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Week 6Population: No participants were enrolled in the tobacco e-cigarette condition.
Self-reported total number of cigarettes smoked per day (Timeline Follow Back)
Outcome measures
| Measure |
Menthol E-cigarette
n=3 Participants
Adult smokers will be switched from using menthol cigarettes to non-menthol cigarettes and a menthol flavored e-cigarette
Cigarette Brand Switching: Adult smokers will be switched from smoking menthol cigarettes to non-menthol cigarettes
|
Tobacco E-cigarette
Adult smokers will be switched from using menthol cigarettes to non-menthol cigarettes and a tobacco flavored e-cigarette
E-cigarette Flavor: Adult smokers will be provided with either menthol or tobacco flavored e-cigarettes in addition to the non-menthol cigarettes
|
|---|---|---|
|
Total Number of Cigarettes Smoked
|
19 cigarettes per day
Standard Deviation 16
|
—
|
SECONDARY outcome
Timeframe: Week 6Population: Analyses were not conducted for this outcome examining use by e-cigarette flavor condition because no participants were enrolled in the tobacco e-cigarette condition.
Self-reported e-cigarette use compared by e-cigarette flavor (Timeline Follow Back)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 6Population: No participants were enrolled in the tobacco e-cigarette condition.
Self-reported subjective ratings of satisfaction with tobacco products (Modified Cigarette/E-cigarette Evaluation Questionnaire), rated 1-7 with higher scores indicating greater satisfaction
Outcome measures
| Measure |
Menthol E-cigarette
n=3 Participants
Adult smokers will be switched from using menthol cigarettes to non-menthol cigarettes and a menthol flavored e-cigarette
Cigarette Brand Switching: Adult smokers will be switched from smoking menthol cigarettes to non-menthol cigarettes
|
Tobacco E-cigarette
Adult smokers will be switched from using menthol cigarettes to non-menthol cigarettes and a tobacco flavored e-cigarette
E-cigarette Flavor: Adult smokers will be provided with either menthol or tobacco flavored e-cigarettes in addition to the non-menthol cigarettes
|
|---|---|---|
|
Tobacco Product Satisfaction
|
1.7 units on a scale
Standard Deviation 1.6
|
—
|
SECONDARY outcome
Timeframe: Week 6Population: No participants were enrolled in the tobacco e-cigarette condition.
Self-reported motivation to quit smoking cigarettes (Contemplation Ladder), rated 1-10, higher scores indicate greater motivation to quit
Outcome measures
| Measure |
Menthol E-cigarette
n=3 Participants
Adult smokers will be switched from using menthol cigarettes to non-menthol cigarettes and a menthol flavored e-cigarette
Cigarette Brand Switching: Adult smokers will be switched from smoking menthol cigarettes to non-menthol cigarettes
|
Tobacco E-cigarette
Adult smokers will be switched from using menthol cigarettes to non-menthol cigarettes and a tobacco flavored e-cigarette
E-cigarette Flavor: Adult smokers will be provided with either menthol or tobacco flavored e-cigarettes in addition to the non-menthol cigarettes
|
|---|---|---|
|
Motivation to Quit Smoking
|
7.7 units on a scale
Standard Deviation 2.1
|
—
|
SECONDARY outcome
Timeframe: Week 6Population: No participants were enrolled in the tobacco e-cigarette condition.
Self-reported nicotine dependence (NIH Promis Dependence Measure), rated 1-5, higher scores indicate greater dependence
Outcome measures
| Measure |
Menthol E-cigarette
n=3 Participants
Adult smokers will be switched from using menthol cigarettes to non-menthol cigarettes and a menthol flavored e-cigarette
Cigarette Brand Switching: Adult smokers will be switched from smoking menthol cigarettes to non-menthol cigarettes
|
Tobacco E-cigarette
Adult smokers will be switched from using menthol cigarettes to non-menthol cigarettes and a tobacco flavored e-cigarette
E-cigarette Flavor: Adult smokers will be provided with either menthol or tobacco flavored e-cigarettes in addition to the non-menthol cigarettes
|
|---|---|---|
|
Nicotine Dependence
|
3.8 score on a scale
Standard Deviation 1.1
|
—
|
Adverse Events
Menthol E-cigarette
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Tobacco E-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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place