NCT01100216

Human Laboratory Study of Smokeless Tobacco Products

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Minnesota · Academic / Other
• Sex: Male
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Smokeless Tobacco

Interventions

Type	Name	Description
OTHER	Nicotine Lozenge	4 mg for 12 days
OTHER	Stonewall Dissolvable Tobacco Pieces	5.6 mg nicotine pieces for 12 days
OTHER	Camel Snus Frost	pouches, 6.2 mg nicotine, for 12 days
OTHER	Skoal Wintergreen	Used at baseline (Days 1 and 2, 5-11) and then at every 7 day wash-out period.

Timeline

• Start date: 2010-03-01
• Primary completion: 2010-12-01
• Completion: 2010-12-01
• First posted: 2010-04-08
• Last updated: 2014-12-10

Locations

1 site across 1 country: United States