Human Laboratory Study of Smokeless Tobacco Products

Smokeless Tobacco Clinical Trial

Official title: Human Laboratory Study of Smokeless Tobacco Products

Status Withdrawn

Clinical Trial Summary

With the advent of restrictions on public smoking, the tobacco industry has introduced a variety of novel smokeless tobacco products (NSTP) to allow continued tobacco use. These products typically have lower tobacco-specific nitrosamines, carcinogens and nicotine than conventional smokeless products out on the market. No studies have compared the effects of NSTP and medicinal nicotine products (MNP) in smokeless tobacco users and whether some of the NSTP products may serve as a cessation tool for smokeless tobacco users. Our hypothesis is that the effects from these products will be directly related to their nicotine content and sensory effects. Products that produce greater effects on outcome measures may serve as potential cessation tools.

Clinical Trial Description

Treatment will be a 3-period crossover study using Commit Nicotine Lozenge, Stonewall Disposable Tobacco Pieces and Camel Snus Frost Pouches. Each period will last 14 days with 11 days of product use and 1.5 days abstinence of all nicotine-containing products for a total of 10 weeks. Participants will begin the study by completing a baseline assessment on their own product, Skoal Wintergreen. ;

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Smokeless Tobacco

• NCT number: NCT01100216
• Study type: Interventional
• Source: University of Minnesota - Clinical and Translational Science Institute
• Status: Withdrawn
• Phase: N/A
• Start date: March 2010
• Completion date: December 2010