Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2026-03-09 @ 9:20 PM
Study NCT ID:
NCT03063034
Status:
COMPLETED
Last Update Posted:
2017-03-14
First Post:
2017-02-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CSD1602: A Crossover Study to Evaluate the Exposure to "Tar" and Nicotine From Two King Size Menthol Cigarette Products
Sponsor:
RAI Services Company
Organization:
Study Overview
Official Title:
CSD1602: A Crossover Study to Evaluate the Exposure to "Tar" and Nicotine From Two King Size Menthol Cigarette Products
Status:
COMPLETED
Status Verified Date:
2017-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: