NCT03153761

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: RAI Services Company · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Accepted

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.

Conditions

• Tobacco Use

Interventions

Type	Name	Description
OTHER	CSD170201AA	A moist snuff product
OTHER	CSD170201AB	A moist snuff product

Timeline

• Start date: 2017-05-08
• Primary completion: 2017-11-17
• Completion: 2017-11-17
• First posted: 2017-05-15
• Last updated: 2018-04-10

Locations

2 sites across 1 country: United States