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This study will evaluate exposure to tar and nicotine from two cigarette products that contain a menthol capsule in the filter, and provide a basis for comparing mouth-level exposure when smokers smoke the two cigarette products.
Subjects will be randomly assigned to the order in which they will smoke two study cigarette products (including one comparator product and one test product). Subjects will smoke each study product exclusively for approximately one week prior to a test visit, with a different product smoked each week over a two-week period. Cigarette butts will be collected the day prior to each test visit for determination of Yield-in-Use (YIU) tar and nicotine levels. Blood samples will be collected at each test visit for determination of blood cotinine levels. Subjects will provide responses to questions during each test visit to assess their cigarette smoking and cigarette butt collection behavior during the preceding day.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1601A, 1601B product use order | Experimental | Subjects will use 1601A for 1 week and then 1601B for 1 week. |
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| 1601B, 1601A product use order | Experimental | Subjects will use 1601B for 1 week and then 1601A for 1 week. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 1601A | Other | A filtered, king size cigarette with a menthol capsule in the filter. |
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| Measure | Description | Time Frame |
|---|---|---|
| Yield-in-use tar per cigarette | To compare the per cigarette YIU tar per cigarette from smoking product 1601A with those from smoking product 1601B. | 2 weeks |
| Yield-in-use nicotine per cigarette | To compare the per cigarette YIU nicotine per cigarette from smoking product 1601A with those from smoking product 1601B. | 2 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jonathan Austin, MD | High Point Clinical Trials Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| High Point Clinical Trials Center | High Point | North Carolina | 27265 | United States |
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| ID | Term |
|---|---|
| D012907 | Smoking |
| D000073869 | Tobacco Smoking |
| D064424 | Tobacco Use |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| 1601B | Other | A filtered, king size cigarette with a menthol capsule in the filter. |
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