Status:
COMPLETED
CSD1601: A Study to Evaluate the Exposure to Tar and Nicotine From Two Cigarette Products That Contain a Menthol Capsule in the Filter
Lead Sponsor:
RAI Services Company
Conditions:
Smoking
Tobacco Smoking
Eligibility:
All Genders
21+ years
Phase:
NA
Brief Summary
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 smok...
Detailed Description
Subjects will be randomly assigned to the order in which they will smoke two study cigarette products (including one comparator product and one test product). Subjects will smoke each study product ex...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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;
Key Trial Info
Start Date :
April 8 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 2 2016
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT04529551
Start Date
April 8 2016
End Date
May 2 2016
Last Update
June 27 2022
Active Locations (1)
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1
High Point Clinical Trials Center
High Point, North Carolina, United States, 27265