NCT03063034

CSD1602: A Crossover Study to Evaluate the Exposure to "Tar" and Nicotine From Two King Size Menthol Cigarette Products

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: RAI Services Company · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Accepted

Summary

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: * Compare the plasma cotinine, a byproduct of your body's processing of nicotine, levels found in users after smoking each of two different cigarettes. * Find out the daily mouth-level exposure to cigarette "tar" and nicotine from smoking each of two different cigarettes in adult smokers. * Determine if certain measures of nicotine dependence change based on the type of cigarette smoked * To compare product liking and intent to use it again.

Detailed description

The study will consist of one group of approximately 40 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.

Conditions

• Smoking

Interventions

Type	Name	Description
OTHER	PD21864AA	A king size menthol cigarette.
OTHER	PD21864AB	A king size menthol cigarette.

Timeline

• Start date: 2017-02-06
• Primary completion: 2017-03-13
• Completion: 2017-03-13
• First posted: 2017-02-24
• Last updated: 2017-03-14

Locations

1 site across 1 country: United States