NCT04529551

CSD1601: A Study to Evaluate the Exposure to Tar and Nicotine From Two Cigarette Products That Contain a Menthol Capsule in the Filter

CSD1601: A Crossover Study to Evaluate the Exposure to Tar and Nicotine From Two Cigarette Products That Contain a Menthol Capsule in the Filter

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 55 (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 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.

Detailed description

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.

Conditions

• Smoking
• Tobacco Smoking
• Tobacco Use

Interventions

Type	Name	Description
OTHER	1601A	A filtered, king size cigarette with a menthol capsule in the filter.
OTHER	1601B	A filtered, king size cigarette with a menthol capsule in the filter.

Timeline

• Start date: 2016-04-08
• Primary completion: 2016-05-02
• Completion: 2016-05-02
• First posted: 2020-08-27
• Last updated: 2022-06-27

Locations

1 site across 1 country: United States