CSD1603: A Crossover Study to Evaluate the Exposure to "Tar" and Nicotine From 100s Menthol Cigarette Products
| Status: | Completed |
|---|---|
| Conditions: | Smoking Cessation |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 3/15/2017 |
| Start Date: | February 6, 2017 |
| End Date: | March 13, 2017 |
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.
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.
The study will consist of one group of approximately 32 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.
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.
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