Ignite Creation Date:
2025-12-24 @ 12:54 PM
Ignite Modification Date:
2025-12-28 @ 1:30 AM
Study NCT ID:
NCT03153761
Status:
COMPLETED
Last Update Posted:
2018-04-10
First Post:
2017-05-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CSD170201: A Study to Evaluate the Exposure to Tobacco Constituents From Two Moist Snuff Products
Sponsor:
RAI Services Company
Organization:
Study Overview
Official Title:
CSD170201: A Crossover Study to Evaluate the Exposure to Tobacco Constituents From Two Moist Snuff Products
Status:
COMPLETED
Status Verified Date:
2018-04
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 tobacco constituents from two moist snuff products, and provide a basis for comparing mouth-level exposure (MLE) in moist snuff users after use of each of the two moist snuff products.
Detailed Description:
This will be an unblinded, single-center, randomized, two-way crossover study, conducted in generally healthy, adult moist snuff users who will be randomly assigned to the order in which they will use two moist snuff study products (comparator product, test product). Enrolled subjects will use one of each of the study products exclusively for approximately one week (seven days +1/-2 day) prior to a test visit, with a different product used each week over a two-week period. During each test visit, subjects will use study product ad libitum during a 6-hour period. Expectoration will be collected from the subjects during each product use. The used study product will be collected after use. Blood samples will be collected at each test visit, prior to study product use, for determination of plasma cotinine levels.
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?: