Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2026-01-05 @ 5:49 PM
Study NCT ID:
NCT04529551
Status:
COMPLETED
Last Update Posted:
2022-06-27
First Post:
2020-08-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CSD1601: A Study to Evaluate the Exposure to Tar and Nicotine From Two Cigarette Products That Contain a Menthol Capsule in the Filter
Sponsor:
RAI Services Company
Organization:
Study Overview
Official Title:
CSD1601: A Crossover Study to Evaluate the Exposure to Tar and Nicotine From Two Cigarette Products That Contain a Menthol Capsule in the Filter
Status:
COMPLETED
Status Verified Date:
2022-06
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 cigarette products that contain a menthol capsule in the filter, and provide a basis for comparing mouth-level exposure when smokers smoke the two cigarette products.
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 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 Yield-in-Use (YIU) tar and nicotine levels. Blood samples will be collected at each test visit for determination of blood 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?: