CSD1603: A Crossover Study to Evaluate the Exposure to "Tar" and Nicotine From 100s Menthol Cigarette Products

Completed · Not applicable

Conditions studied: Smoking

In brief

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.

Key facts

Study ID

NCT03063047

Run by

RAI Services Company

People needed

29

Starts

2017-02-06

Expected to finish

2017-03-13

Last updated by the study team

2017-03-14

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).
• 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.

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

• DaVita Clinical Research — Lakewood, Colorado, United States

Full record on ClinicalTrials.gov

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