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N/A N=104 Treatment

Evaluation of Oral Tobacco as a Harm Reduction Method for Smokers

Tobacco Use Disorder

Enrolled (actual)
104
Serious AEs
0.0%
Results posted
Sep 2015
Primary outcome: Primary: Product Preference — 27; 23; 24; 24 participants

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Camel Snus (Other); Marlboro Snus (Other); Stonewall (Other); Ariva (Other); General Snus (Other)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
University of Minnesota
Primary completion
Oct 2009

Outcome Measures

OutcomeResultp-value
PRIMARY
Product Preference
27; 23; 24; 24; 0
PRIMARY
Abstinence From Cigarettes
12; 8; 5; 3

Summary

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.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Unstable medical or psychiatric condition.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00711100). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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