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| Name | Class |
|---|---|
| Covance | INDUSTRY |
| R.J. Reynolds Tobacco Company | INDUSTRY |
| MAS (Materials Analytical Services), LLC | OTHER |
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This study will assess environmental emissions of selected compounds in a test chamber after cigarette smoking or e-cigarette vaping.
Secondhand smoke is the aged and diluted combination of smoke exhaled by a smoker and sidestream smoke (smoke from the lit end of a cigarette). Electronic cigarettes are different from tobacco-burning cigarettes in that they produce vapor, not smoke. For consistency with common usage, secondhand smoke (SHS) refers to true secondhand smoke from cigarettes and secondhand vapor from e-cigarettes.
The goals of this study are to 1) increase understanding of the composition of SHS from e-cigarettes, 2) quantitatively compare the amount of SHS generated by e-cigarettes and a market sample of commercial e-cigarettes to leading brand styles of commercial tobacco-burning cigarettes, and 3) quantitate the emission factors of e-cigarettes including the market-sample e-cigarettes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Leading U.S. tobacco-burning non-menthol cigarette | Active Comparator | Leading U.S. non-menthol cigarette |
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| Leading U.S. tobacco-burning menthol cigarette | Active Comparator | Leading U.S. menthol cigarette |
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| Electronic cigarette #1 | Experimental | VUSE® (menthol flavor, 29 mg nicotine) |
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| Electronic cigarette #2 | Experimental | VUSE® (original flavor, 29 mg nicotine) |
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| Electronic cigarette #3 | Experimental | VUSE® (original flavor, 14 mg nicotine) |
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| U.S. Market-sample electronic cigarettes (two brands) | Experimental | blu™ (any variety) and NJOY® (any variety) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Leading U.S. non-menthol cigarette | Other | Tobacco-burning non-menthol cigarette |
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| Measure | Description | Time Frame |
|---|---|---|
| To assess differences in levels of selected SHS constituents in an environmental test chamber after human smoking of e-cigarette #1, #2, and #3 compared to after human smoking of tobacco-burning cigarettes. | 2 weeks for participants in Cohorts 1 and 2; and approximately 4 weeks for participants in Cohorts 3, 4, and 5 |
| Measure | Description | Time Frame |
|---|---|---|
| To determine selected SHS constituent emission factors for each tobacco-burning cigarette, each e-cigarette, and the market-sample e-cigarettes (collectively). | 2 weeks for participants in Cohorts 1, 2, and 6; and approximately 4 weeks for participants in Cohorts 3, 4, and 5 | |
| To assess the differences in levels of selected SHS constituents in an environmental test chamber after human smoking of e-cigarettes and tobacco-burning cigarettes compared to after a non-smoking blank condition. |
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Inclusion Criteria:
Able to read, understand, and willing to sign an Informed Consent Form (ICF) and complete questionnaires written in English.
Generally healthy males or females, 21 years of age or older at Screening.
Able to meet cohort-specific requirements as follows:
Cohort 1 - Leading U.S. tobacco-burning non-menthol cigarette, and
Cohort 2 - Leading U.S. tobacco-burning menthol cigarette:
Cohort 3 - Electronic cigarette #1 smokers, and
Cohort 4 - Electronic cigarette #2 smokers:
Cohort 5 - Electronic cigarette #3 smokers:
Cohort 6 - U.S Market-sample electronic cigarette smokers:
Females of childbearing potential must be willing to use a form of contraception acceptable to the Investigator from the time of signing informed consent until study discharge or be surgically sterile for at least 90 days prior to enrollment;
Able to safely perform the required study procedures, as determined by the Investigator.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nathan Segall, MD, CPI | Clinical Research Atlanta | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research Atlanta | Stockbridge | Georgia | 30281 | United States |
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| Leading U.S. menthol cigarette | Other | Tobacco-burning menthol cigarette |
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| Electronic cigarette #1 | Other | Electronic cigarette |
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| Electronic cigarette #2 | Other | Electronic cigarette |
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| Electronic cigarette #3 | Other | Electronic cigarette |
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| U.S. Market-sample electronic cigarettes | Other | Marketed electronic cigarettes |
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| 2 weeks for participants in Cohorts 1, 2, and 6; and approximately 4 weeks for participants in Cohorts 3, 4, and 5 |
| To assess differences in levels of additional selected SHS constituents in an environmental test chamber after human smoking of e-cigarettes compared to after human smoking of tobacco-burning cigarettes. | 2 weeks for participants in Cohorts 1, 2, and 6; and approximately 4 weeks for participants in Cohorts 3, 4, and 5 |
| ID | Term |
|---|---|
| D012907 | Smoking |
| D000072137 | Vaping |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D008610 | Menthol |
| D009538 | Nicotine |
| C471607 | UBE2N protein, human |
| ID | Term |
|---|---|
| D003511 | Cyclohexanols |
| D000441 | Hexanols |
| D005233 | Fatty Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000081005 | Cyclohexane Monoterpenes |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D039821 | Monoterpenes |
| D013729 | Terpenes |
| D008055 | Lipids |
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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