Evaluation of Oral Tobacco as a Harm Reduction Method for Smokers

Completed · Not applicable

Conditions studied: Tobacco Use Disorder

In brief

Recently, tobacco companies have developed new oral tobacco products that are purportedly less harmful than conventional tobacco products. These products have not been tested by independent research for their health effects or consumer palatability. In addition, it is not known if these products will be used in addition to cigarette smoking or as a substitute to cigarettes. These two studies will examine four oral tobacco products to answer some of these questions. The goals of this first study will be to examine: 1) the brand of oral tobacco products which is preferred by cigarette smokers and the pattern and amount of product use when used as a switching tool; 2) the characteristics that are associated with product choice; 3) nicotine exposure from these products; and 4) the withdrawal symptoms from the tobacco products and potential for continued use. Specifically, our primary aims hypotheses were: 1) the product that will be chosen by most smokers will be based on taste and sensory aspects of the product with products higher in nicotine content more likely to be chosen as the preferred product; and 2) subjects will experience no difficulty using the product for complete cigarette substitution, but a small minority will engage in dual product use. For the secondary aims, we hypothesized: 1) that compared to the subjects' own brand of cigarettes, the biomarkers for exposure for the oral tobacco products will be significantly lower; 2) withdrawal symptoms from the oral products are likely to occur, but are likely to be mild compared to cigarette withdrawal.

Key facts

Study ID

NCT00711100

Run by

University of Minnesota

People needed

104

Starts

2008-08-01

Expected to finish

2010-12-01

Last updated by the study team

2019-11-18

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Cigarette smokers who smoke 10 or more cigarettes per day
• Generally good health

You may not qualify if…

• Unstable medical or psychiatric condition.

Where it is running

• Univeristy of Minnesota — Minneapolis, Minnesota, United States
• Oregon Research Institute — Eugene, Oregon, United States

Full record on ClinicalTrials.gov

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