- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03063034
CSD1602: A Crossover Study to Evaluate the Exposure to "Tar" and Nicotine From Two King Size Menthol Cigarette Products
March 13, 2017 updated by: RAI Services Company
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.
Study Overview
Detailed Description
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.
Study Type
Interventional
Enrollment (Actual)
39
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Colorado
-
Lakewood, Colorado, United States, 80228
- Davita Clinical Research
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: PD21864AA, PD21864AB
Subjects will use PD21864AA for 1 week and then PD21864AB for 1 week.
|
A king size menthol cigarette.
A king size menthol cigarette.
|
Active Comparator: PD21864AB, PD21864AA
Subjects will use PD21864AB for 1 week and then PD21864AA for 1 week.
|
A king size menthol cigarette.
A king size menthol cigarette.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mouth-level exposure (MLE) "tar" per cigarette and MLE nicotine per cigarette.
Time Frame: 2 weeks
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Elizabeth Yoon, FNP-C, Davita Clinical Research
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Fagerstrom K. Determinants of tobacco use and renaming the FTND to the Fagerstrom Test for Cigarette Dependence. Nicotine Tob Res. 2012 Jan;14(1):75-8. doi: 10.1093/ntr/ntr137. Epub 2011 Oct 24. No abstract available.
- St Charles FK, Kabbani AA, Borgerding MF. Estimating tar and nicotine exposure: human smoking versus machine generated smoke yields. Regul Toxicol Pharmacol. 2010 Feb;56(1):100-10. doi: 10.1016/j.yrtph.2009.08.011. Epub 2009 Aug 31.
- Shepperd CJ, St Charles FK St, Lien M, Dixon M . Validation of methods for determining consumer smoked cigarette yields from cigarette filter analysis. Beitr Tabakforsch Int. 2006;22:176-184.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 6, 2017
Primary Completion (Actual)
March 13, 2017
Study Completion (Actual)
March 13, 2017
Study Registration Dates
First Submitted
February 20, 2017
First Submitted That Met QC Criteria
February 20, 2017
First Posted (Actual)
February 24, 2017
Study Record Updates
Last Update Posted (Actual)
March 14, 2017
Last Update Submitted That Met QC Criteria
March 13, 2017
Last Verified
March 1, 2017
More Information
Terms related to this study
Other Study ID Numbers
- CSD1602
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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