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| ID | Type | Description | Link |
|---|---|---|---|
| 2U54DA036151-06 | U.S. NIH Grant/Contract | View source |
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Study enrollment was temporarily paused in 2020 due to COVID-19. Study was closed without further enrollment in 2022.
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
| Food and Drug Administration (FDA) | FED |
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This study will investigate within-person changes in smoking behavior when current menthol smokers are switched to non-menthol cigarettes and either tobacco or menthol flavored e-cigarettes.
The goals of this project include evaluating within-subject changes in cigarette satisfaction and smoking behavior after switching from menthol cigarettes and investigating whether outcomes differ between subjects based on use of menthol vs. tobacco flavored e-cigarettes. Within-person changes in cigarette satisfaction and smoking behavior will be assessed during the last week of the non-menthol cigarette smoking period compared to the menthol cigarette smoking period. Preference and use of both the cigarette and e-cigarette products during the switching period will be compared and the extent to which menthol flavored (vs. tobacco) e-cigarettes are preferred among menthol smokers will be evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Menthol e-cigarette | Experimental | Adult smokers will be switched from using menthol cigarettes to non-menthol cigarettes and a menthol flavored e-cigarette |
|
| Tobacco e-cigarette | Experimental | Adult smokers will be switched from using menthol cigarettes to non-menthol cigarettes and a tobacco flavored e-cigarette |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cigarette Brand Switching | Other | Adult smokers will be switched from smoking menthol cigarettes to non-menthol cigarettes |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total Number of Cigarettes Smoked | Self-reported total number of cigarettes smoked per day (Timeline Follow Back) | Week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| E-cigarette Use | Self-reported e-cigarette use compared by e-cigarette flavor (Timeline Follow Back) | Week 6 |
| Tobacco Product Satisfaction | Self-reported subjective ratings of satisfaction with tobacco products (Modified Cigarette/E-cigarette Evaluation Questionnaire), rated 1-7 with higher scores indicating greater satisfaction |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Krysten Bold, Ph.D. | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale University | New Haven | Connecticut | 06511 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Menthol E-cigarette | Adult smokers will be switched from using menthol cigarettes to non-menthol cigarettes and a menthol flavored e-cigarette Cigarette Brand Switching: Adult smokers will be switched from smoking menthol cigarettes to non-menthol cigarettes |
| FG001 | Tobacco E-cigarette | Adult smokers will be switched from using menthol cigarettes to non-menthol cigarettes and a tobacco flavored e-cigarette E-cigarette Flavor: Adult smokers will be provided with either menthol or tobacco flavored e-cigarettes in addition to the non-menthol cigarettes |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
No participants were enrolled in the tobacco e-cigarette condition prior to study termination.
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| ID | Title | Description |
|---|---|---|
| BG000 | Menthol E-cigarette | Adult smokers will be switched from using menthol cigarettes to non-menthol cigarettes and a menthol flavored e-cigarette Cigarette Brand Switching: Adult smokers will be switched from smoking menthol cigarettes to non-menthol cigarettes |
| BG001 | Tobacco E-cigarette |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Total Number of Cigarettes Smoked | Self-reported total number of cigarettes smoked per day (Timeline Follow Back) | No participants were enrolled in the tobacco e-cigarette condition. | Posted | Mean | Standard Deviation | cigarettes per day | Week 6 |
|
Adverse event data were collected for the 10 weeks of study participation.
No participants were enrolled in the tobacco e-cigarette condition.
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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 | Menthol E-cigarette | Adult smokers will be switched from using menthol cigarettes to non-menthol cigarettes and a menthol flavored e-cigarette Cigarette Brand Switching: Adult smokers will be switched from smoking menthol cigarettes to non-menthol cigarettes |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Krysten Bold | Yale School of Medicine | 203-974-7603 | krysten.bold@yale.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 | May 16, 2019 | Feb 9, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 19, 2021 | Feb 13, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D064424 | Tobacco Use |
| ID | Term |
|---|---|
| D001519 | Behavior |
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Within-subject design comparing smoking behavior when using menthol vs. non-menthol cigarettes with either menthol or tobacco flavored e-cigarettes
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| E-cigarette Flavor | Other | Adult smokers will be provided with either menthol or tobacco flavored e-cigarettes in addition to the non-menthol cigarettes |
|
| Week 6 |
| Motivation to Quit Smoking | Self-reported motivation to quit smoking cigarettes (Contemplation Ladder), rated 1-10, higher scores indicate greater motivation to quit | Week 6 |
| Nicotine Dependence | Self-reported nicotine dependence (NIH Promis Dependence Measure), rated 1-5, higher scores indicate greater dependence | Week 6 |
Adult smokers will be switched from using menthol cigarettes to non-menthol cigarettes and a tobacco flavored e-cigarette E-cigarette Flavor: Adult smokers will be provided with either menthol or tobacco flavored e-cigarettes in addition to the non-menthol cigarettes |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | E-cigarette Use | Self-reported e-cigarette use compared by e-cigarette flavor (Timeline Follow Back) | Analyses were not conducted for this outcome examining use by e-cigarette flavor condition because no participants were enrolled in the tobacco e-cigarette condition. | Posted | Week 6 |
|
|
| Secondary | Tobacco Product Satisfaction | Self-reported subjective ratings of satisfaction with tobacco products (Modified Cigarette/E-cigarette Evaluation Questionnaire), rated 1-7 with higher scores indicating greater satisfaction | No participants were enrolled in the tobacco e-cigarette condition. | Posted | Mean | Standard Deviation | units on a scale | Week 6 |
|
|
|
| Secondary | Motivation to Quit Smoking | Self-reported motivation to quit smoking cigarettes (Contemplation Ladder), rated 1-10, higher scores indicate greater motivation to quit | No participants were enrolled in the tobacco e-cigarette condition. | Posted | Mean | Standard Deviation | units on a scale | Week 6 |
|
|
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| Secondary | Nicotine Dependence | Self-reported nicotine dependence (NIH Promis Dependence Measure), rated 1-5, higher scores indicate greater dependence | No participants were enrolled in the tobacco e-cigarette condition. | Posted | Mean | Standard Deviation | score on a scale | Week 6 |
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| 0 |
| 3 |
| 0 |
| 3 |
| 0 |
| 3 |
| EG001 | Tobacco E-cigarette | Adult smokers will be switched from using menthol cigarettes to non-menthol cigarettes and a tobacco flavored e-cigarette E-cigarette Flavor: Adult smokers will be provided with either menthol or tobacco flavored e-cigarettes in addition to the non-menthol cigarettes | 0 | 0 | 0 | 0 | 0 | 0 |
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