Health Effects of SLT, Cigarette Smoking, and New Tobacco Products
Condition: Nicotine Dependence
MeSH terms: Tobacco Use Disorder
Intervention: Nicotine gum and lozenge; Taboka; Camel Snus
Intervention description: Nicotine replacement; smokeless tobacco product; smokeless tobacco product
Intervention MeSH terms: Nicotine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 130.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Biomarkers; Smoking; Tobacco; Cessation

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects between 18-70 years of age

          -  Smoking at least 10 cigarettes/day for at least one year

          -  Good physical and mental health as evidenced by a medical history with no unstable
             medical conditions.

        Exclusion Criteria:

          -  Uncontrolled chronic disease or condition that requires medical attention during the
             course of the study

          -  Contraindications for nicotine replacement products: active ulcers, recent heart
             attack, heart disease or irregular heart beat, uncontrolled high blood pressure, or
             medication use that might affect tobacco use

          -  Current unstable psychiatric diagnoses or persons who currently are adjusting
             medication dose. (within the last 3 months)

          -  Subjects with current or recent (within 6 months) alcohol or drug abuse problem

          -  Other regular tobacco use such as regular cigar or pipe smoking

          -  Currently using other nicotine replacement products

          -  Chronic use of any drug that could interact with the study drugs.