The research project will determine the level of nicotine in ST products that will lead to the greatest reduction in toxicant exposure
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
278
Comparison of different dosages of nicotine effect on tobacco use patterns, subjective response and biomarker levels.
Comparison of different dosages of nicotine effect on tobacco use patterns, subjective response and biomarker levels.
Comparison of different dosages of nicotine effect on tobacco use patterns, subjective response and biomarker levels.
University of Minnesota
Minneapolis, Minnesota, United States
Oregon Research Institute
Eugene, Oregon, United States
1. To determine if switching to ST products with reduced toxicant levels will result in reduction of biomarkers of exposure and toxicity. 2. To determine the nicotine levels of ST that would lead to the greatest reduction in tobacco toxicant exposure.
Time frame: 8 weeks
To determine the extent to which varying low nicotine ST products leads to compensatory tobacco use.
Time frame: 8 weeks
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