Evaluation of Oral Tobacco as a Harm Reduction Method for Smokers
Condition: Tobacco Use Disorder
MeSH terms: Tobacco Use Disorder
Study type: Interventional

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.
    

Detailed description: 
      This study will be accomplished by allowing subjects to sample the products and choose one
      oral tobacco product that they will use instead of cigarettes for a two week period. After
      the two weeks, they will discontinue all tobacco use and withdrawal symptoms and abstinence
      rates will be observed.

      Subjects will attend an orientation visit where the study will be explained in detail.
      Interested subjects will sign a consent form and be scheduled to return for baseline
      measures. Subjects will have a review of medical history to verify that they are in generally
      good health and do not have contraindications to the study products. Eligible subjects will
      collect one week of baseline measures while smoking at their normal rate: measures include
      daily diaries of smoking, questionnaires and urine samples. At the second baseline visit,
      they will receive samples of the oral tobacco products. The tobacco products tested are five
      novel oral products recently introduced to the market: 1) Camel Snus (higher nicotine); 2)
      General Snus (higher nicotine); 3) Marlboro Snus (lower nicotine); and two compressed tobacco
      tablets, 4) Ariva (lower nicotine), or 5) Stonewall (higher nicotine). All of these tobacco
      products are purported to have reduced levels of tobacco-specific nitrosamines.

      During sample weeks, subjects will be given 10 pouches/tablets of each product in a
      within-subject design and instructed to use at least three of the daily products in the
      morning of sample day and resume smoking in the afternoon and through the following day. They
      will sample the next product in a similar manner. The order of product was randomized. All
      subjects will sample all five products. This design will allow a short, but adequate trial of
      each product to determine preference. After the sampling weeks, subjects will choose the
      product they will want to use to quit smoking. They will be supplied that product over the
      next two weeks.

      During the two weeks of product use during smoking abstinence, subjects will come to weekly
      clinic visits and then a follow-up visits at 1 week and a phone call at 4 weeks after the end
      of treatment. At baseline, and 2 weeks post cigarette cessation, subjects will bring in a
      urine sample from their first morning void and bloods will be drawn. At each visit, subjects
      will have vital signs obtained (blood pressure, heart rate, weight and carbon monoxide
      level), they will complete several subjective forms regarding tobacco use, withdrawal
      symptoms, and mood. Subjects will receive brief behavioral counseling for smoking cessation
      at all visits.

      In addition, during the sample weeks and at the end of two weeks of study product use,
      subjects will submit three used chews that will be sent to CDC to be analyzed for the tobacco
      constituents.
    

Intervention name(s): Camel Snus; Marlboro Snus; Stonewall; Ariva; General Snus
Intervention type(s): Other; Other; Other; Other; Other
Intervention description(s): All subjects will sample Camel Snus and determine if they would prefer to use this product during the abstinence phase over the other products sampled. Sampling period (duration: 1/2 day) requires use of at least 3 samples of Camel Snus. Intervention period (duration: 2 weeks) involves ad libitum daily use (if Camel Snus is chosen for use) during abstinence phase.; All subjects will sample Marlboro Snus and determine if they would prefer to use this product during the abstinence phase over the other products sampled. Sampling period (duration: 1/2 day) requires use of at least 3 samples of Marlboro Snus. Intervention period (duration: 2 weeks) involves ad libitum daily use (if Marlboro Snus is chosen for use) during abstinence phase.; All subjects will sample Stonewall and determine if they would prefer to use this product during the abstinence phase over the other products sampled. Sampling period (duration: 1/2 day) requires use of at least 3 samples of Stonewall. Intervention period (duration: 2 weeks) involves ad libitum daily use (if Stonewall is chosen for use) during abstinence phase.; All subjects will sample Ariva and determine if they would prefer to use this product during the abstinence phase over the other products sampled. Sampling period (duration: 1/2 day) requires use of at least 3 samples of Ariva. Intervention period (duration: 2 weeks) involves ad libitum daily use (if Ariva is chosen for use) during abstinence phase.; All subjects will sample General Snus and determine if they would prefer to use this product during the abstinence phase over the other products sampled. Sampling period (duration: 1/2 day) requires use of at least 3 samples of General Snus. Intervention period (duration: 2 weeks) involves ad libitum daily use (if General Snus is chosen for use) during abstinence phase.
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Substitution for cigarettes; Oral tobacco products