Trial Outcomes & Findings for Menthol Flavored E-cigarette Use During a Simulated Ban of Menthol Cigarettes (NCT NCT03164668)
NCT ID: NCT03164668
Last Updated: 2024-07-10
Results Overview
Number of cigarettes smoked per day as self-reported on tobacco diary
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
37 participants
Primary outcome timeframe
1 month
Results posted on
2024-07-10
Participant Flow
Participants included as having "started" the study are those who completed the baseline visit
Participant milestones
| Measure |
Avoid Menthol Cigs; Menthol E-cig Then Tobacco E-cigs
Participants avoid smoking menthol cigarettes. For the first month of study they receive menthol flavored e-cigarettes and for the second month they receive tobacco flavored e-cigarettes
|
Avoid Menthol Cigs; Tobacco E-cig Then Menthol E-cigs
Participants avoid smoking menthol cigarettes. For the first month of study they receive tobacco flavored e-cigarettes and for the second month they receive menthol flavored e-cigarettes
|
Usual Cigs; Menthol E-cig Then Tobacco E-cigs
Participants can continue to smoke their usual cigarettes. For the first month of study they receive menthol flavored e-cigarettes and for the second month they receive tobacco flavored e-cigarettes
|
Usual Cigs; Tobacco E-cig Then Menthol E-cigs
Participants can continue to smoke their usual cigarettes. For the first month of study they receive tobacco flavored e-cigarettes and for the second month they receive menthol flavored e-cigarettes
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
11
|
7
|
10
|
9
|
|
Overall Study
Completed Week 4
|
11
|
5
|
6
|
6
|
|
Overall Study
COMPLETED
|
10
|
5
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
4
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Menthol Flavored E-cigarette Use During a Simulated Ban of Menthol Cigarettes
Baseline characteristics by cohort
| Measure |
Avoid Menthol Cigs; Menthol E-cig Then Tobacco E-cigs
n=11 Participants
Participants avoid smoking menthol cigarettes. For the first month of study they receive menthol flavored e-cigarettes and for the second month they receive tobacco flavored e-cigarettes
|
Avoid Menthol Cigs; Tobacco E-cig Then Menthol E-cigs
n=7 Participants
Participants avoid smoking menthol cigarettes. For the first month of study they receive tobacco flavored e-cigarettes and for the second month they receive menthol flavored e-cigarettes
|
Usual Cigs; Menthol E-cig Then Tobacco E-cigs
n=10 Participants
Participants can continue to smoke their usual cigarettes. For the first month of study they receive menthol flavored e-cigarettes and for the second month they receive tobacco flavored e-cigarettes
|
Usual Cigs; Tobacco E-cig Then Menthol E-cigs
n=9 Participants
Participants can continue to smoke their usual cigarettes. For the first month of study they receive tobacco flavored e-cigarettes and for the second month they receive menthol flavored e-cigarettes
|
Total
n=37 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
46 years
STANDARD_DEVIATION 11 • n=5 Participants
|
49 years
STANDARD_DEVIATION 10 • n=7 Participants
|
48 years
STANDARD_DEVIATION 8 • n=5 Participants
|
47 years
STANDARD_DEVIATION 14 • n=4 Participants
|
47 years
STANDARD_DEVIATION 10 • n=21 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 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
|
0 Participants
n=21 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
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
37 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 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
|
0 Participants
n=21 Participants
|
|
Race (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
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=5 Participants
|
7 participants
n=7 Participants
|
10 participants
n=5 Participants
|
9 participants
n=4 Participants
|
37 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 1 monthPopulation: Participants were randomized to either continue to smoke their usual cigarettes or to avoid menthol cigarettes. Within each group, participants received, in random order, one month of menthol flavored e-cigarettes and one month of tobacco flavored e-cigarettes. The overall number of participants entered for each outcome therefore represents the total number from both relevant randomization conditions (see Participant flow for details) in whom at least 1 week of data was provided.
Number of cigarettes smoked per day as self-reported on tobacco diary
Outcome measures
| Measure |
Avoid Menthol Cigarettes; Menthol E-cigarettes
n=16 Participants
Participants avoided smoking menthol cigarettes and received menthol flavored e-cigarettes
|
Avoid Menthol Cigarettes; Tobacco E-cigarettes
n=17 Participants
Participants avoided smoking menthol cigarettes and received tobacco flavored e-cigarettes
|
Can Continue Smoking Usual Cigarettes; Menthol E-cigarettes
n=13 Participants
Participants could continue to smoke their usual cigarettes and received menthol flavored e-cigarettes
|
Can Continue Smoking Usual Cigarettes; Tobacco E-cigarettes
n=13 Participants
Participants could continue to smoke their usual cigarettes and received tobacco flavored e-cigarettes
|
|---|---|---|---|---|
|
Number of Cigarettes Smoked Per Day
|
2.2 model estimated cigarettes per day
|
1.8 model estimated cigarettes per day
|
6.0 model estimated cigarettes per day
|
7.1 model estimated cigarettes per day
|
PRIMARY outcome
Timeframe: 1 monthPopulation: Participants were randomized to either continue to smoke their usual cigarettes or to avoid menthol cigarettes. Within each group, participants received, in random order, one month of menthol flavored e-cigarettes and one month of tobacco flavored e-cigarettes. The overall number of participants entered for each outcome therefore represents the total number from both relevant randomization conditions (see Participant flow for details) in whom at least 1 week of data was provided.
Self-reported number of puffs of e-cigarettes used per day
Outcome measures
| Measure |
Avoid Menthol Cigarettes; Menthol E-cigarettes
n=16 Participants
Participants avoided smoking menthol cigarettes and received menthol flavored e-cigarettes
|
Avoid Menthol Cigarettes; Tobacco E-cigarettes
n=18 Participants
Participants avoided smoking menthol cigarettes and received tobacco flavored e-cigarettes
|
Can Continue Smoking Usual Cigarettes; Menthol E-cigarettes
n=16 Participants
Participants could continue to smoke their usual cigarettes and received menthol flavored e-cigarettes
|
Can Continue Smoking Usual Cigarettes; Tobacco E-cigarettes
n=15 Participants
Participants could continue to smoke their usual cigarettes and received tobacco flavored e-cigarettes
|
|---|---|---|---|---|
|
Number of E-cigarette Puffs Used Per Day
|
61.4 model estimated e-cig puffs per day
|
57 model estimated e-cig puffs per day
|
25.5 model estimated e-cig puffs per day
|
14.9 model estimated e-cig puffs per day
|
Adverse Events
Avoid Menthol Cigarettes; Receive Menthol E-cigarettes
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Avoid Menthol Cigarettes; Receive Tobacco E-cigarettes
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Usual Cigarettes; Receive Menthol E-cigarettes
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Usual Cigarettes; Receive Tobacco E-cigarettes
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 |
Avoid Menthol Cigarettes; Receive Menthol E-cigarettes
n=16 participants at risk
Participants avoid smoking menthol cigarettes and receive menthol flavored e-cigarettes
|
Avoid Menthol Cigarettes; Receive Tobacco E-cigarettes
n=18 participants at risk
Participants avoid smoking menthol cigarettes and receive tobacco flavored e-cigarettes
|
Usual Cigarettes; Receive Menthol E-cigarettes
n=16 participants at risk
Participants can continue to smoke their usual cigarettes and receive menthol flavored e-cigarettes
|
Usual Cigarettes; Receive Tobacco E-cigarettes
n=15 participants at risk
Participants can continue to smoke their usual cigarettes and receive tobacco flavored e-cigarettes
|
|---|---|---|---|---|
|
General disorders
Headache
|
0.00%
0/16 • For the duration of each participant's participation in the specified condition (up to approximately 4 weeks for each participant)
Adverse events rated as possibly, probably or definitely related to being in the study
|
5.6%
1/18 • For the duration of each participant's participation in the specified condition (up to approximately 4 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 in the specified condition (up to approximately 4 weeks for each participant)
Adverse events rated as possibly, probably or definitely related to being in the study
|
0.00%
0/15 • For the duration of each participant's participation in the specified condition (up to approximately 4 weeks for each participant)
Adverse events rated as possibly, probably or definitely related to being in the study
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/16 • For the duration of each participant's participation in the specified condition (up to approximately 4 weeks for each participant)
Adverse events rated as possibly, probably or definitely related to being in the study
|
0.00%
0/18 • For the duration of each participant's participation in the specified condition (up to approximately 4 weeks for each participant)
Adverse events rated as possibly, probably or definitely related to being in the study
|
6.2%
1/16 • For the duration of each participant's participation in the specified condition (up to approximately 4 weeks for each participant)
Adverse events rated as possibly, probably or definitely related to being in the study
|
0.00%
0/15 • For the duration of each participant's participation in the specified condition (up to approximately 4 weeks for each participant)
Adverse events rated as possibly, probably or definitely related to being in the study
|
|
General disorders
Lightheaded
|
0.00%
0/16 • For the duration of each participant's participation in the specified condition (up to approximately 4 weeks for each participant)
Adverse events rated as possibly, probably or definitely related to being in the study
|
0.00%
0/18 • For the duration of each participant's participation in the specified condition (up to approximately 4 weeks for each participant)
Adverse events rated as possibly, probably or definitely related to being in the study
|
6.2%
1/16 • For the duration of each participant's participation in the specified condition (up to approximately 4 weeks for each participant)
Adverse events rated as possibly, probably or definitely related to being in the study
|
0.00%
0/15 • For the duration of each participant's participation in the specified condition (up to approximately 4 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