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| Name | Class |
|---|---|
| Davita Clinical Research | INDUSTRY |
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This study will evaluate exposure to "tar" and nicotine from two menthol cigarette products and provide a basis for comparing mouth-level exposure when smokers smoke the two cigarette products. Mouth-level exposure is the measurement of substance trapped in the cigarette butt after smoking the cigarette.
Other purposes of this study are to:
The study will consist of one group of approximately 32 adult subjects randomly assigned to the order in which they will smoke two study menthol 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 MLE "tar" and nicotine levels. Blood samples will be collected at each test visit for determination of plasma 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 |
|---|---|---|---|
| PD21871AA, PD21872AA | Active Comparator | Subjects will use PD21871AA for 1 week and then PD21872AA for 1 week. |
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| PD21872AA, PD21871AA | Active Comparator | Subjects will use PD21872AA for 1 week and then PD21871AA for 1 week. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PD21871AA | Other | A 100s size menthol cigarette. |
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| Measure | Description | Time Frame |
|---|---|---|
| Mouth-level exposure (MLE) "tar" per cigarette and MLE nicotine per cigarette. | To compare the per cigarette MLE parameters (MLE "tar" per cigarette and MLE nicotine per cigarette) from smoking PD21871AA with those from smoking PD21872AA in adult smokers. | 2 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elizabeth Yoon, FNP-C | Davita Clinical Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| DaVita Clinical Research | Lakewood | Colorado | 80228 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19723554 | Background | St Charles FK, Kabbani AA, Borgerding MF. Estimating tar and nicotine exposure: human smoking versus machine generated smoke yields. Regul Toxicol Pharmacol. 2010 Feb;56(1):100-10. doi: 10.1016/j.yrtph.2009.08.011. Epub 2009 Aug 31. | |
| 22025545 | Background | Fagerstrom K. Determinants of tobacco use and renaming the FTND to the Fagerstrom Test for Cigarette Dependence. Nicotine Tob Res. 2012 Jan;14(1):75-8. doi: 10.1093/ntr/ntr137. Epub 2011 Oct 24. No abstract available. |
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| ID | Term |
|---|---|
| D012907 | Smoking |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| PD21872AA | Other | A 100s size menthol cigarette. |
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| Background | Shepperd CJ, St Charles FK St, Lien M, Dixon M . Validation of methods for determining consumer smoked cigarette yields from cigarette filter analysis. Beitr Tabakforsch Int. 2006;22:176-184. |