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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tobacco then Menthol | Experimental | A 30-minute session with tobacco flavor then a 30-min session with menthol flavor |
|
| Menthol then tobacco | Experimental | A 30-minute session with menthol flavor then a 30-min session with tobacco flavor |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| E-cigarette product | Device | Participants will be randomized 1:1 to e-cigarette flavor order either:
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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?
| during the intervention |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kansas Medical Center | Kansas City | Missouri | 66160 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Tobacco Then Menthol | 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:
|
| BG001 | Menthol Then Tobacco |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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?
| Participants who participated in the study | Posted | Mean | Full Range | units on a scale | during the intervention |
|
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.
No different definitions.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tobacco Pod | Participants receive tobacco flavored pod for the electronic cigarette during the first during the 30-minute session with the electronic cigarette. Then participants received a menthol-flavored pod at the second session. The researcher and participant were blinded to flavor during the visits. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Leah Lambart Graduate Research Assistant | University of Kansas Medical Center | 9139457862 | llambart@kumc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 11, 2023 | Mar 30, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D014029 | Tobacco Use Disorder |
| D000072137 | Vaping |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D012907 | Smoking |
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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.
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| 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. | 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. | during the intervention |
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:
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Menthol | 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. |
|
|
| Secondary | 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. | Participants who participated in the study | Posted | Mean | Full Range | units on a scale | during the intervention |
|
|
|
| Secondary | 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. | Participants who participated in the study. | Posted | Mean | Full Range | units on a scale | during the intervention |
|
|
|
| Secondary | 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. | Posted | Mean | Full Range | units on a scale | during the intervention |
|
|
|
| 0 |
| 52 |
| 0 |
| 52 |
| 0 |
| 52 |
| EG001 | Menthol Pod | Participants receive menthol flavored pod for the electronic cigarette during the first during the 30-minute session with the electronic cigarette. Then participants received a tobacco-flavored pod at the second session. The researcher and participant were blinded to flavor during the visits. | 0 | 52 | 0 | 52 | 0 | 52 |
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| D001519 |
| Behavior |