Trial Outcomes & Findings for Effect of Banning Menthol Flavorant on Cigarette and E-Cigarette Use (NCT NCT03402243)
NCT ID: NCT03402243
Last Updated: 2021-08-10
Results Overview
Total number of cigarettes smoked and puffs of e-cigarettes used
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
47 participants
Primary outcome timeframe
6 weeks
Results posted on
2021-08-10
Participant Flow
Participant milestones
| Measure |
Menthol Ban Only for Cigarettes
Participants will have available to them non-menthol cigarettes, menthol and tobacco flavored versions of a cigarette-like e-cigarette, menthol and tobacco flavored versions of a tank like e-cigarette and nicotine gum and lozenge
Menthol ban on cigarettes: Participants will have menthol and tobacco flavored e-cigarettes available but only non-menthol cigarettes
|
Menthol Ban for Cigarettes and E-cigarettes
Participants will have available to them non-menthol cigarettes, tobacco flavored version of a cigarette-like e-cigarette, tobacco flavored version of a tank like e-cigarette and nicotine gum and lozenge
Menthol ban on cigarettes and e-cigarettes: Participants will have neither menthol flavored cigarettes or e-cigarettes available
|
No Menthol Ban
Participants will have available to them menthol and non-menthol cigarettes, menthol and tobacco flavored versions of a cigarette-like e-cigarette, menthol and tobacco flavored versions of a tank like e-cigarette and nicotine gum and lozenge
No menthol ban: Participant will have menthol and tobacco flavored cigarettes and e-cigarettes available
|
|---|---|---|---|
|
Overall Study
STARTED
|
16
|
15
|
16
|
|
Overall Study
COMPLETED
|
13
|
12
|
14
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Banning Menthol Flavorant on Cigarette and E-Cigarette Use
Baseline characteristics by cohort
| Measure |
Menthol Ban Only for Cigarettes
n=16 Participants
Participants will have available to them non-menthol cigarettes, menthol and tobacco flavored versions of a cigarette-like e-cigarette, menthol and tobacco flavored versions of a tank like e-cigarette and nicotine gum and lozenge
Menthol ban on cigarettes: Participants will have menthol and tobacco flavored e-cigarettes available but only non-menthol cigarettes
|
Menthol Ban for Cigarettes and E-cigarettes
n=15 Participants
Participants will have available to them non-menthol cigarettes, tobacco flavored version of a cigarette-like e-cigarette, tobacco flavored version of a tank like e-cigarette and nicotine gum and lozenge
Menthol ban on cigarettes and e-cigarettes: Participants will have neither menthol flavored cigarettes or e-cigarettes available
|
No Menthol Ban
n=16 Participants
Participants will have available to them menthol and non-menthol cigarettes, menthol and tobacco flavored versions of a cigarette-like e-cigarette, menthol and tobacco flavored versions of a tank like e-cigarette and nicotine gum and lozenge
No menthol ban: Participant will have menthol and tobacco flavored cigarettes and e-cigarettes available
|
Total
n=47 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
45.8 years
STANDARD_DEVIATION 9.8 • n=5 Participants
|
44.9 years
STANDARD_DEVIATION 11.2 • n=7 Participants
|
44.1 years
STANDARD_DEVIATION 10.4 • n=5 Participants
|
44.9 years
STANDARD_DEVIATION 10.3 • n=4 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
45 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=5 Participants
|
15 participants
n=7 Participants
|
16 participants
n=5 Participants
|
47 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 6 weeksTotal number of cigarettes smoked and puffs of e-cigarettes used
Outcome measures
| Measure |
Menthol Ban Only for Cigarettes
n=16 Participants
Participants will have available to them non-menthol cigarettes, menthol and tobacco flavored versions of a cigarette-like e-cigarette, menthol and tobacco flavored versions of a tank like e-cigarette and nicotine gum and lozenge
Menthol ban on cigarettes: Participants will have menthol and tobacco flavored e-cigarettes available but only non-menthol cigarettes
|
Menthol Ban for Cigarettes and E-cigarettes
n=15 Participants
Participants will have available to them non-menthol cigarettes, tobacco flavored version of a cigarette-like e-cigarette, tobacco flavored version of a tank like e-cigarette and nicotine gum and lozenge
Menthol ban on cigarettes and e-cigarettes: Participants will have neither menthol flavored cigarettes or e-cigarettes available
|
No Menthol Ban
n=16 Participants
Participants will have available to them menthol and non-menthol cigarettes, menthol and tobacco flavored versions of a cigarette-like e-cigarette, menthol and tobacco flavored versions of a tank like e-cigarette and nicotine gum and lozenge
No menthol ban: Participant will have menthol and tobacco flavored cigarettes and e-cigarettes available
|
|---|---|---|---|
|
Amount of Tobacco Product Used
Cigarettes smoked per day
|
13.1 tobacco products use per day
Standard Deviation 5.5
|
18.6 tobacco products use per day
Standard Deviation 5.7
|
15.3 tobacco products use per day
Standard Deviation 5.0
|
|
Amount of Tobacco Product Used
Puffs of e-cigarettes used per day
|
56.7 tobacco products use per day
Standard Deviation 180.2
|
10.7 tobacco products use per day
Standard Deviation 24.9
|
4.5 tobacco products use per day
Standard Deviation 8.6
|
SECONDARY outcome
Timeframe: 6 weeksNumber of packs of cigarettes obtained and amount of e-liquid obtained from the "experimental marketplace"
Outcome measures
| Measure |
Menthol Ban Only for Cigarettes
n=16 Participants
Participants will have available to them non-menthol cigarettes, menthol and tobacco flavored versions of a cigarette-like e-cigarette, menthol and tobacco flavored versions of a tank like e-cigarette and nicotine gum and lozenge
Menthol ban on cigarettes: Participants will have menthol and tobacco flavored e-cigarettes available but only non-menthol cigarettes
|
Menthol Ban for Cigarettes and E-cigarettes
n=15 Participants
Participants will have available to them non-menthol cigarettes, tobacco flavored version of a cigarette-like e-cigarette, tobacco flavored version of a tank like e-cigarette and nicotine gum and lozenge
Menthol ban on cigarettes and e-cigarettes: Participants will have neither menthol flavored cigarettes or e-cigarettes available
|
No Menthol Ban
n=16 Participants
Participants will have available to them menthol and non-menthol cigarettes, menthol and tobacco flavored versions of a cigarette-like e-cigarette, menthol and tobacco flavored versions of a tank like e-cigarette and nicotine gum and lozenge
No menthol ban: Participant will have menthol and tobacco flavored cigarettes and e-cigarettes available
|
|---|---|---|---|
|
How Much of Each Product is Obtained From the "Experimental Marketplace"
Packs of cigarettes
|
22.6 units of tobacco
Standard Deviation 10.38
|
29.3 units of tobacco
Standard Deviation 11.06
|
28.8 units of tobacco
Standard Deviation 10.7
|
|
How Much of Each Product is Obtained From the "Experimental Marketplace"
Units of e-cigarette liquid
|
3.13 units of tobacco
Standard Deviation 3.16
|
1.2 units of tobacco
Standard Deviation 1.57
|
1.06 units of tobacco
Standard Deviation 1.34
|
SECONDARY outcome
Timeframe: 6 weeksBased on a question asking how motivated from 1 (not at all) to 10 (extremely) the participant is to quit smoking cigarettes at this time
Outcome measures
| Measure |
Menthol Ban Only for Cigarettes
n=16 Participants
Participants will have available to them non-menthol cigarettes, menthol and tobacco flavored versions of a cigarette-like e-cigarette, menthol and tobacco flavored versions of a tank like e-cigarette and nicotine gum and lozenge
Menthol ban on cigarettes: Participants will have menthol and tobacco flavored e-cigarettes available but only non-menthol cigarettes
|
Menthol Ban for Cigarettes and E-cigarettes
n=15 Participants
Participants will have available to them non-menthol cigarettes, tobacco flavored version of a cigarette-like e-cigarette, tobacco flavored version of a tank like e-cigarette and nicotine gum and lozenge
Menthol ban on cigarettes and e-cigarettes: Participants will have neither menthol flavored cigarettes or e-cigarettes available
|
No Menthol Ban
n=16 Participants
Participants will have available to them menthol and non-menthol cigarettes, menthol and tobacco flavored versions of a cigarette-like e-cigarette, menthol and tobacco flavored versions of a tank like e-cigarette and nicotine gum and lozenge
No menthol ban: Participant will have menthol and tobacco flavored cigarettes and e-cigarettes available
|
|---|---|---|---|
|
Motivation to Quit Smoking Cigarettes
|
3.6 units on a scale
Standard Deviation 2.2
|
3.1 units on a scale
Standard Deviation 2.2
|
3.2 units on a scale
Standard Deviation 1.7
|
Adverse Events
Menthol Ban Only for Cigarettes
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Menthol Ban for Cigarettes and E-cigarettes
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
No Menthol Ban
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Menthol Ban Only for Cigarettes
n=16 participants at risk
Participants will have available to them non-menthol cigarettes, menthol and tobacco flavored versions of a cigarette-like e-cigarette, menthol and tobacco flavored versions of a tank like e-cigarette and nicotine gum and lozenge
Menthol ban on cigarettes: Participants will have menthol and tobacco flavored e-cigarettes available but only non-menthol cigarettes
|
Menthol Ban for Cigarettes and E-cigarettes
n=15 participants at risk
Participants will have available to them non-menthol cigarettes, tobacco flavored version of a cigarette-like e-cigarette, tobacco flavored version of a tank like e-cigarette and nicotine gum and lozenge
Menthol ban on cigarettes and e-cigarettes: Participants will have neither menthol flavored cigarettes or e-cigarettes available
|
No Menthol Ban
n=16 participants at risk
Participants will have available to them menthol and non-menthol cigarettes, menthol and tobacco flavored versions of a cigarette-like e-cigarette, menthol and tobacco flavored versions of a tank like e-cigarette and nicotine gum and lozenge
No menthol ban: Participant will have menthol and tobacco flavored cigarettes and e-cigarettes available
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
throat irritation / cough
|
0.00%
0/16 • For the duration of each participant's participation (up to 6 weeks for each participant)
Adverse events rated as possibly, probably or definitely related to being in the study
|
6.7%
1/15 • For the duration of each participant's participation (up to 6 weeks for each participant)
Adverse events rated as possibly, probably or definitely related to being in the study
|
0.00%
0/16 • For the duration of each participant's participation (up to 6 weeks for each participant)
Adverse events rated as possibly, probably or definitely related to being in the study
|
|
Respiratory, thoracic and mediastinal disorders
pain / discomfort during inhalation
|
0.00%
0/16 • For the duration of each participant's participation (up to 6 weeks for each participant)
Adverse events rated as possibly, probably or definitely related to being in the study
|
6.7%
1/15 • For the duration of each participant's participation (up to 6 weeks for each participant)
Adverse events rated as possibly, probably or definitely related to being in the study
|
0.00%
0/16 • For the duration of each participant's participation (up to 6 weeks for each participant)
Adverse events rated as possibly, probably or definitely related to being in the study
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place