Trial Outcomes & Findings for Comparative Acceptability of Tobacco and Menthol Flavored E-cigarettes (NCT NCT04996940)
NCT ID: NCT04996940
Last Updated: 2023-09-13
Results Overview
Using the questionnaire scale "Intentions for Future Use" How much each participant intends to use the products in the future. Scale: "Think about the product you just used. If this was the only flavor available, how likely would you be to try this flavor again? 1. Extremely unlikely 2. Unlikely 3. Neutral 4. Likely 5. Extremely likely The range of observed responses from participants for both groups was 1-5. Not all participants completed all study measures so the number of respondents is lower than enrolled.
COMPLETED
NA
52 participants
during the intervention
2023-09-13
Participant Flow
Participant milestones
| Measure |
Tobacco Flavor Pod Then Menthol Flavor Pod
At lab visit 1 participant receive tobacco flavored pod for the electronic cigarette during the during the 30 minute session with the electronic cigarette. The researcher and participant were blinded to flavor during the visit.
Following at least a 48-hour washout period, at lab visit 2, receive menthol flavored pod for the electronic cigarette during the 30 minute session with the electronic cigarette. The researcher and participant were blinded to flavor during the visit.
|
Menthol Flavor Pod Then Tobacco Flavor Pod
At lab visit 1 participant receive menthol flavored pod for the electronic cigarette during the 30 minute session with the electronic cigarette. The researcher and participant were blinded to flavor during the visit.
Following at least a 48-hour washout period, at lab visit 2, receive tobacco flavored pod for the electronic cigarette during the 30 minute session with the electronic cigarette. The researcher and participant were blinded to flavor during the visit.
|
|---|---|---|
|
Overall Study
STARTED
|
28
|
24
|
|
Overall Study
COMPLETED
|
28
|
24
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparative Acceptability of Tobacco and Menthol Flavored E-cigarettes
Baseline characteristics by cohort
| Measure |
Tobacco Then Menthol
n=28 Participants
A 30-minute session with tobacco flavor then a 30-min session with menthol flavor
E-cigarette product: Participants will be randomized 1:1 to e-cigarette flavor order either:
1. tobacco e-cigarette
2. menthol e-cigarette
|
Menthol Then Tobacco
n=24 Participants
A 30-minute session with menthol flavor then a 30-min session with tobacco flavor
E-cigarette product: Participants will be randomized 1:1 to e-cigarette flavor order either:
1. tobacco e-cigarette
2. menthol e-cigarette
|
Total
n=52 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.0 years
n=5 Participants
|
56.0 years
n=7 Participants
|
55 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
28 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
25 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
28 participants
n=5 Participants
|
24 participants
n=7 Participants
|
52 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: during the interventionPopulation: Participants who participated in the study
Using the questionnaire scale "Intentions for Future Use" How much each participant intends to use the products in the future. Scale: "Think about the product you just used. If this was the only flavor available, how likely would you be to try this flavor again? 1. Extremely unlikely 2. Unlikely 3. Neutral 4. Likely 5. Extremely likely The range of observed responses from participants for both groups was 1-5. Not all participants completed all study measures so the number of respondents is lower than enrolled.
Outcome measures
| Measure |
Tobacco
n=41 Participants
Participants received a tobacco flavored pod for the electronic cigarette during a 30-minute session with the electronic cigarette. The researcher and participant were blinded to flavor during the visits.
|
Menthol
n=41 Participants
Participants received a menthol-flavored pod for the electronic cigarette during a 30-minute session with the electronic cigarette. The researcher and participant were blinded to flavor during the visits.
|
|---|---|---|
|
Questionnaire Scale "Intentions for Future Use"
|
3.1 units on a scale
Interval 1.0 to 5.0
|
3.7 units on a scale
Interval 1.0 to 5.0
|
SECONDARY outcome
Timeframe: during the interventionPopulation: Participants who participated in the study
Please indicate how you are feeling right now on a scale from 0 to 100 where 0 is not at all and 100 is extremely. How pleasant would the e-cigarette be to use right now? The observed range of responses from participants for both arms was 0 to 100. Not all participants completed all study measures so the number of respondents is lower than enrolled.
Outcome measures
| Measure |
Tobacco
n=41 Participants
Participants received a tobacco flavored pod for the electronic cigarette during a 30-minute session with the electronic cigarette. The researcher and participant were blinded to flavor during the visits.
|
Menthol
n=41 Participants
Participants received a menthol-flavored pod for the electronic cigarette during a 30-minute session with the electronic cigarette. The researcher and participant were blinded to flavor during the visits.
|
|---|---|---|
|
Questionnaire Scale "Subjective Vaping Experience"
|
38.0 units on a scale
Interval 0.0 to 100.0
|
48.1 units on a scale
Interval 0.0 to 100.0
|
SECONDARY outcome
Timeframe: during the interventionPopulation: Participants who participated in the study.
On a scale from 0 to 100 where 0 is not at all and 100 is extremely, to what extent did you like the flavor you just used? The observed range of responses from participants in both arms was from 0 to 100. Not all participants completed all study measures so the number of respondents is lower than enrolled.
Outcome measures
| Measure |
Tobacco
n=41 Participants
Participants received a tobacco flavored pod for the electronic cigarette during a 30-minute session with the electronic cigarette. The researcher and participant were blinded to flavor during the visits.
|
Menthol
n=41 Participants
Participants received a menthol-flavored pod for the electronic cigarette during a 30-minute session with the electronic cigarette. The researcher and participant were blinded to flavor during the visits.
|
|---|---|---|
|
Questionnaire Scale "Perceptions of Flavor"
|
34.0 units on a scale
Interval 0.0 to 100.0
|
51.0 units on a scale
Interval 0.0 to 100.0
|
SECONDARY outcome
Timeframe: during the interventionOn a scale from 0 to 100 where 0 is not at all and 100 is extremely, how willing would you be to use the flavor you just used again in the future? The observed range of responses from participants in both arms was from 0 to 100. Not all participants completed all study measures so the number of respondents is lower than enrolled.
Outcome measures
| Measure |
Tobacco
n=41 Participants
Participants received a tobacco flavored pod for the electronic cigarette during a 30-minute session with the electronic cigarette. The researcher and participant were blinded to flavor during the visits.
|
Menthol
n=41 Participants
Participants received a menthol-flavored pod for the electronic cigarette during a 30-minute session with the electronic cigarette. The researcher and participant were blinded to flavor during the visits.
|
|---|---|---|
|
Questionnaire Scale "Product Demand"
|
38.7 units on a scale
Interval 0.0 to 100.0
|
49.7 units on a scale
Interval 0.0 to 100.0
|
Adverse Events
Tobacco Pod
Menthol Pod
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Leah Lambart Graduate Research Assistant
University of Kansas Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place