An interventional study of E-cigarette product in Tobacco Use Disorder, sponsored by University of Kansas Medical Center. Completed at 1 site in United States. Open to participants aged 21 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-13.
Sponsored by University of Kansas Medical Center · Not applicable, Interventional, and Other
The study is a randomized crossover trial. Current menthol smokers will complete a session with each flavor of an electronic cigarette: menthol and tobacco. The objective of this survey is to assess for flavor preference.
Participants who report typically smoking menthol cigarettes will be invited to complete a session. Participants will undergo overnight tobacco/nicotine abstinence before the visit (eCO\<12ppm). Participants will then be randomized 1:1 to e-cigarette flavor order (tobacco e-cigarette, menthol e-cigarette). They will complete a 30-minute ad libitum session with the first product, based on randomization, followed by a 1.5 hour standard washout period, followed by a 30-minute ad libitum vaping session with the second product. Throughout each session, puff topography will be measured via a pressure sensor attached to the e-cigarette device. Participants will complete self-report measures of smoking urges and withdrawal symptoms pre- and post-vaping session. In addition, they will complete measures of subjective vaping experience, perceptions of flavor, product demand, and intentions for future use.
968 studies on the registry are indexed under Tobacco Use Disorder; 126 are open to participants now.
This study's enrollment of 52 is below the median of 89 across 851 interventional studies indexed under Tobacco Use Disorder.
Browse Tobacco Use Disorder studies →University of Kansas Medical Center is the lead sponsor of 483 studies on the registry; 113 are open to participants now.
Of its 38 completed or terminated interventional studies of FDA-regulated products, 24 (63%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
A 30-minute session with tobacco flavor then a 30-min session with menthol flavor
Device: E-cigarette product
A 30-minute session with menthol flavor then a 30-min session with tobacco flavor
Device: E-cigarette product
Participants will be randomized 1:1 to e-cigarette flavor order either: 1. tobacco e-cigarette 2. menthol e-cigarette
Questionnaire Scale "Intentions for Future Use"
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.
Time frame: during the intervention
Questionnaire Scale "Subjective Vaping Experience"
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.
Time frame: during the intervention
Questionnaire Scale "Perceptions of Flavor"
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.
Time frame: during the intervention
Questionnaire Scale "Product Demand"
On 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.
Time frame: during the intervention
| Milestone | Tobacco Flavor Pod Then Menthol Flavor Pod | Menthol Flavor Pod Then Tobacco Flavor Pod |
|---|---|---|
| Started | 28 | 24 |
| Completed | 28 | 24 |
| Not completed | 0 | 0 |
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.
| units on a scale | Tobacco | Menthol |
|---|---|---|
| Questionnaire Scale "Intentions for Future Use" | 3.1 (1 to 5) | 3.7 (1 to 5) |
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.
| units on a scale | Tobacco | Menthol |
|---|---|---|
| Questionnaire Scale "Subjective Vaping Experience" | 38.0 (0 to 100) | 48.1 (0 to 100) |
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.
| units on a scale | Tobacco | Menthol |
|---|---|---|
| Questionnaire Scale "Perceptions of Flavor" | 34.0 (0 to 100) | 51.0 (0 to 100) |
On 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.
| units on a scale | Tobacco | Menthol |
|---|---|---|
| Questionnaire Scale "Product Demand" | 38.7 (0 to 100) | 49.7 (0 to 100) |
Collected over Adverse events were assessed for each participant during the study which ranged from 1 week to 1 month, and were assessed at 6 months after last study visit completion for each participant, a total of up to 7 months.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Tobacco Pod | 0/52 (0%) | 0/52 (0%) | 0/52 (0%) |
| Menthol Pod | 0/52 (0%) | 0/52 (0%) | 0/52 (0%) |
| Age, Continuous(years) | Tobacco Then Menthol | Menthol Then Tobacco | Total |
|---|---|---|---|
| Mean | 54.0 (32 to 70) | 56.0 (23 to 77) | 55 (23 to 77) |
| Sex: Female, Male(Participants) | Tobacco Then Menthol | Menthol Then Tobacco | Total |
|---|---|---|---|
| Female | 12 | 10 | 22 |
| Male | 16 | 14 | 30 |
| Ethnicity (NIH/OMB)(Participants) | Tobacco Then Menthol | Menthol Then Tobacco | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 28 | 24 | 52 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Tobacco Then Menthol | Menthol Then Tobacco | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 25 | 21 | 46 |
| White | 3 | 3 | 6 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Tobacco Then Menthol | Menthol Then Tobacco | Total |
|---|---|---|---|
| United States | 28 | 24 | 52 |
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University of Kansas Medical Center