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

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.

Inclusion criteria

• Able to read, understand, and willing to sign an Informed Consent Form (ICF).
• Generally healthy males and females, 21 years of age or older, at Screening-Enrollment Visit.
• Self-reports smoking at least seven cigarettes per day and inhaling the smoke.
• Usual brand of cigarette is one of the brand styles specified.
• Smoked usual brand for ≥ 3 months.
• Agrees to exclusively smoke the study cigarettes and not smoke or use any other tobacco or nicotine-containing products during the course of the study.
• Able to read and comprehend English.
• Able to safely perform the required study procedures, as determined by the Investigator.

Exclusion criteria

• Self-reported history of heart disease, kidney disease, asthma or any other lung disease, diabetes, liver disease, hypertension, or hypercholesterolemia.
• At risk for heart disease, i.e., obesity (body mass index [BMI] ≥ 40 kg/m2), as determined by the Investigator.
• Females ≥ 35 years of age currently using systemic, estrogen-containing contraception, or hormone replacement therapy.
• Postponing a decision to quit smoking (defined as planning a quit attempt within 30 days of the Screening-Enrollment Visit) to participate in this study.
• Use of any medication or substance that aids in smoking cessation, including but not limited to any nicotine replacement therapy (NRT) (e.g., nicotine gum, lozenge, patch), varenicline (Chantix®), bupropion (Wellbutrin®, Zyban®), or lobelia extract within 30 days prior to the Screening-Enrollment Visit.
• Females who test positive for pregnancy, are pregnant or breastfeeding, or plan to become pregnant during the course of the study.
• Determined by the Investigator to be inappropriate for the study.