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CSD170201: A Study to Evaluate the Exposure to Tobacco Constituents From Two Moist Snuff Products

Tobacco Use Clinical Trial

Official title:
CSD170201: A Crossover Study to Evaluate the Exposure to Tobacco Constituents From Two Moist Snuff Products

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03153761
Study type Interventional
Source RAI Services Company
Contact
Status Completed
Phase N/A
Start date May 8, 2017
Completion date November 17, 2017
View Details
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