N/A
N=104
Evaluation of Oral Tobacco as a Harm Reduction Method for Smokers
Tobacco Use Disorder
Bottom Line
View on ClinicalTrials.gov: NCT00711100 ↗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
| Outcome | Result | p-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.
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.