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The purpose of this formative study is to provide preliminary data regarding how the availability of menthol flavored e-cigarettes affects tobacco use behavior in the context of a ban on menthol flavored cigarettes
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual cigs; menthol e-cig then tobacco e-cigs | Other | 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 | Other | 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 |
|
| avoid menthol cigs; menthol e-cig then tobacco e-cigs | Other | 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 | Other | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| menthol flavored e-cigarette | Other | menthol flavored e-cigarette |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Cigarettes Smoked Per Day | Number of cigarettes smoked per day as self-reported on tobacco diary | 1 month |
| Number of E-cigarette Puffs Used Per Day | Self-reported number of puffs of e-cigarettes used per day | 1 month |
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Inclusion Criteria:
Exclusion Criteria:
The investigators will evaluate if there are other reasons why someone may not be eligible to participate
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical and Translational Sciences Institute | Minneapolis | Minnesota | 55455 | United States |
Participants included as having "started" the study are those who completed the baseline visit
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| FG002 | 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 |
| FG003 | 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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Those who completed the Baseline visit of the study
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Avoid Menthol Cigs; Tobacco E-cig Then Menthol E-cigs |
| 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 | Number of Cigarettes Smoked Per Day | Number of cigarettes smoked per day as self-reported on tobacco diary | 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. | Posted | Number | model estimated cigarettes per day | 1 month |
|
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
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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 | Avoid Menthol Cigarettes; Receive Menthol E-cigarettes | Participants avoid smoking menthol cigarettes and receive menthol flavored e-cigarettes |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | General disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Kotlyar | University of Minnesota | 612-625-1160 | kotly001@umn.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Oct 28, 2019 | Dec 19, 2023 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D014029 | Tobacco Use Disorder |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| tobacco flavored e-cigarette | Other | tobacco flavored e-cigarette |
|
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 |
| BG002 | 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 |
| BG003 | 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 |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 |
| Avoid Menthol Cigarettes; Tobacco E-cigarettes |
Participants avoided smoking menthol cigarettes and received tobacco flavored e-cigarettes |
| OG002 | Can Continue Smoking Usual Cigarettes; Menthol E-cigarettes | Participants could continue to smoke their usual cigarettes and received menthol flavored e-cigarettes |
| OG003 | Can Continue Smoking Usual Cigarettes; Tobacco E-cigarettes | Participants could continue to smoke their usual cigarettes and received tobacco flavored e-cigarettes |
|
|
|
| Primary | Number of E-cigarette Puffs Used Per Day | Self-reported number of puffs of e-cigarettes used per day | 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. | Posted | Number | model estimated e-cig puffs per day | 1 month |
|
|
|
|
| 0 |
| 16 |
| 0 |
| 16 |
| 0 |
| 16 |
| EG001 | Avoid Menthol Cigarettes; Receive Tobacco E-cigarettes | Participants avoid smoking menthol cigarettes and receive tobacco flavored e-cigarettes | 0 | 18 | 0 | 18 | 1 | 18 |
| EG002 | Usual Cigarettes; Receive Menthol E-cigarettes | Participants can continue to smoke their usual cigarettes and receive menthol flavored e-cigarettes | 0 | 16 | 0 | 16 | 1 | 16 |
| EG003 | Usual Cigarettes; Receive Tobacco E-cigarettes | Participants can continue to smoke their usual cigarettes and receive tobacco flavored e-cigarettes | 0 | 15 | 0 | 15 | 0 | 15 |
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Lightheaded | General disorders | Non-systematic Assessment |
|
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| Comparison of those assigned to conditions in which they receive tobacco flavored e-cigarettes relative to conditions in which they receive menthol flavored e-cigarettes | Estimated mean ratio | 0.74 | 2-Sided | 95 | 0.59 | 0.92 | Estimated mean ratio of number of puffs of e-cigarettes used per day among those in conditions in which they receive tobacco flavored e-cigarettes relative to conditions in which they receive menthol flavored e-cigarettes | Superiority |