NCT01067599

Novel Determinants and Measures of Smokeless Tobacco Use: Study 2

Novel Determinants and Measures of Smokeless Tobacco Use: Study 2 Effects of Switching Levels of Nicotine and TSNA in Products on Smokeless Tobacco Use

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 278 (actual)
• Sponsor: University of Minnesota · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The research project will determine the level of nicotine in ST products that will lead to the greatest reduction in toxicant exposure

Detailed description

This is a randomized, multi-site trial determining the effects of switching smokeless tobacco (ST) users to lower toxicant ST products which vary in nicotine levels on biomarkers of exposure and patterns of use. ST users will undergo a two week baseline assessment period and then randomly assigned to one of three oral tobacco products (lower NNK plus NNN product with three different levels of nicotine) for a period of 8-weeks. Follow-up will occur at 9 and 20 weeks.

Conditions

• Tobacco Use Disorder
• Nicotine Dependence

Interventions

Type	Name	Description
OTHER	Low nicotine	Comparison of different dosages of nicotine effect on tobacco use patterns, subjective response and biomarker levels.
OTHER	Medium nicotine	Comparison of different dosages of nicotine effect on tobacco use patterns, subjective response and biomarker levels.
OTHER	High nicotine	Comparison of different dosages of nicotine effect on tobacco use patterns, subjective response and biomarker levels.

Timeline

• Start date: 2012-03-01
• Primary completion: 2015-08-01
• Completion: 2016-10-01
• First posted: 2010-02-11
• Last updated: 2018-02-26

Locations

2 sites across 1 country: United States