Health Effects of SLT, Cigarette Smoking, and New Tobacco Products
Condition: Nicotine Dependence
MeSH terms: Tobacco Use Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      The use of smokeless tobacco (ST) as a substitute for cigarette smoking has been suggested
      since it is considered by some to be a less harmful tobacco product (Russell, Jarvis and
      Feyerabend, 1980; Russell et al, 1981; Rodu, 1994). ST does not have the volatile
      constituents and carbon monoxide (CO) that are found in cigarette smoke. Since ST is not
      smoked there would be less risk of cardiovascular and lung disease. In addition the harm
      associated with second hand smoke would be eliminated. Although the health risks are reduced
      in ST users, they still exist due to the presence of nitrosamines found in ST. A better
      approach would be to use nicotine replacement that did not contain carcinogens, however the
      cost of such NRT could be prohibitive especially in third world countries where the rate of
      smoking is continuing to rise and the per capita income is much lower than in the United
      States.

      Purpose: The goal of this study is to evaluate the health effects of Camel Snus, the new oral
      tobacco product produced by RJ Reynolds and Taboka, produced by Phillip Morris. These
      products are pasteurized rather than fermented and contain less moisture to eliminate
      spitting. They are marketed as an alternative to cigarette smoking.
    

Detailed description: 
      Cigarette smokers (n=125) will be recruited from the local metropolitan area using multiple
      media outlets. Subjects who are medically and psychologically healthy will be recruited for
      the study. Cigarette smokers will be informed of the study over the telephone and asked to
      answer a brief tobacco use history and medical screening questionnaire. If subjects pass the
      initial screening for the study, they will be asked to attend an orientation meeting at the
      Tobacco Use Research Center where the study will be explained in more detail, informed
      consent will be obtained and a full screening evaluation will occur. This evaluation includes
      the completion of several comprehensive tobacco use and social history forms and a complete
      physical and psychological screening.

      Subjects will be required to attend the clinic once during Week 1 and once during Week 2 of
      the study in order to obtain baseline data. At the end of Week 2, cigarette smokers will be
      randomly assigned to either: 1) quit tobacco use and will be offered the choice of using
      nicotine gum or lozenge, depending on personal preference (n= 25) or they will be assigned to
      switch to: 2) Taboka (n=50) or 3) Camel Snus (n=50). Subjects sampled different flavors of
      the products for 1 week and then used the product for the next 4 weeks. During the four
      weeks, subjects will be asked to attend weekly clinic visits during which time study data
      will be collected. After the 4 weeks of study product use, subjects will be required to taper
      off of the tobacco or nicotine product over the next one week and then cease all tobacco use.
      Follow-up visits will be conducted 1 week and 11 weeks after completion of the study and
      outcome measures will be taken at that time. Blood and urine samples will be collected and
      analyzed for tobacco related toxicants during the treatment period.
    

Intervention name(s): Nicotine gum and lozenge; Taboka; Camel Snus
Intervention type(s): Drug; Other; Other
Intervention description(s): Nicotine replacement; smokeless tobacco product; smokeless tobacco product
Other intervention name(s): Commit, Nicorette
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Biomarkers; Smoking; Tobacco; Cessation