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

Completed · Not applicable

Conditions studied: Smoking, Tobacco Smoking, Tobacco Use

In brief

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.

Key facts

Study ID

NCT04529551

Run by

RAI Services Company

People needed

55

Starts

2016-04-08

Expected to finish

2016-05-02

Last updated by the study team

2022-06-27

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Able to read, understand, and willing to sign an Informed Consent Form (ICF) written in English;
• 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;
• Subject does not intend to delay a decision to quit smoking to participate in the study.
• 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.

You may not qualify if…

• 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;

Where it is running

• High Point Clinical Trials Center — High Point, North Carolina, United States

Full record on ClinicalTrials.gov

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