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

Study Overview
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Brief Summary
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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: 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
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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.

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

Conditions
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Smoking

Intervention / Treatment
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* Other: PD21864AA
* Other: PD21864AB


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PD21864AA, PD21864AB<br>Subjects will use PD21864AA for 1 week and then PD21864AB for 1 week. | Other: PD21864AA<br>* A king size menthol cigarette.<br>Other: PD21864AB<br>* A king size menthol cigarette.<br>|
| Active Comparator: PD21864AB, PD21864AA<br>Subjects will use PD21864AB for 1 week and then PD21864AA for 1 week. | Other: PD21864AA<br>* A king size menthol cigarette.<br>Other: PD21864AB<br>* A king size menthol cigarette.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 PD21864AA with those from smoking PD21864AB in adult smokers. | 2 weeks |