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| Name | Class |
|---|---|
| Inflamax Research Limited | UNKNOWN |
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This study will evaluate exposure to tobacco constituents from two moist snuff products, and provide a basis for comparing mouth-level exposure (MLE) in moist snuff users after use of each of the two moist snuff products.
This will be an unblinded, single-center, randomized, two-way crossover study, conducted in generally healthy, adult moist snuff users who will be randomly assigned to the order in which they will use two moist snuff study products (comparator product, test product). Enrolled subjects will use one of each of the study products exclusively for approximately one week (seven days +1/-2 day) prior to a test visit, with a different product used each week over a two-week period. During each test visit, subjects will use study product ad libitum during a 6-hour period. Expectoration will be collected from the subjects during each product use. The used study product will be collected after use. Blood samples will be collected at each test visit, prior to study product use, for determination of plasma cotinine levels.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CSD170202AA, CSD170202AB Use Group | Experimental | Use of product CSD170202AA exclusively for approximately one week (seven days +1/-2 day) prior to a test visit, followed by use of product CSD170202AB exclusively for approximately one week (seven days +1/-2 day) prior to a test visit. |
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| CSD170202AB, CSD170202AA Use Group | Experimental | Use of product CSD170202AB exclusively for approximately one week (seven days +1/-2 day) prior to a test visit, followed by use of product CSD170202AA exclusively for approximately one week (seven days +1/-2 day) prior to a test visit. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CSD170202AA | Other | A moist snuff product |
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| Measure | Description | Time Frame |
|---|---|---|
| Mouth-Level Exposure (MLE) of nicotine per gram (or product) | 6 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nathan Segall, MD | Clinical Research Atlanta | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research Atlanta | Stockbridge | Georgia | 30281 | United States |
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| ID | Term |
|---|---|
| D064424 | Tobacco Use |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| CSD170202AB | Other | A moist snuff product |
|