Effectiveness of Using Reduced Nicotine Cigarettes in Men and Women Smokers to Combat Nicotine Addiction
Condition: Nicotine Dependence; Tobacco Use Disorder
MeSH terms: Tobacco Use Disorder
Study type: Observational

Summary: 
      This is a 2-year study involving the progressive reduction in the nicotine content of
      cigarettes. The investigators believe that at the end of the study smokers of cigarettes with
      progressively reduced nicotine content will be "weaned" from nicotine. At the end of the
      study, the result will be a decreased level of nicotine dependence. When smokers are again
      free to choose any smoking behavior, they will smoke fewer cigarettes and/or have a greater
      interest in quitting compared to a control group that smokes their usual cigarettes.
    

Detailed description: 
      This is a 2-year, randomized, two-arm study involving a 6-month period of progressive
      reduction in the nicotine content of cigarettes. During the first year (tapering/maintenance
      phases), subjects will smoke progressively reduced nicotine content (RNC) cigarettes over a
      period of six months, and then remain on the lowest nicotine content cigarette for an
      additional six months. Comparisons will be made with a control group in which subjects will
      smoke their usual normal nicotine yield cigarettes. There will be a one year follow-up phase
      during which subjects will be monitored and will be free to resume smoking a commercial
      cigarette of their choice, or to quit.

      We hypothesize that smokers of cigarettes with progressively reduced nicotine content will
      experience a reduction in nicotine intake without compensatory oversmoking. This will serve
      to "wean" them from nicotine and result in a decreased level of nicotine dependence. Once
      this has occurred, subjects will then be able to maintain their reduced level of nicotine
      intake for the 6 months that they continue smoking the lowest level RNC cigarette. When they
      are again free to choose any smoking behavior (follow-up phase), as a result of the period of
      lowered dependence they will smoke fewer cigarettes and/or have a greater interest in
      quitting compared to the control group, whose level of nicotine dependence is hypothesized to
      be sustained throughout.

      Primary Hypotheses:

        1. Nicotine intake will be lower for the RNC group than for the control group.

        2. Exposure to tobacco smoke gas phase constituents will be similar for the RNC and control
           group.

        3. Exposure to tobacco smoke tar constituents will be similar for the RNC and control
           group.

        4. Cardiovascular biomarkers of inflammation, platelet activation, endothelial dysfunction,
           and HDL cholesterol will be lower for the RNC group than for the control group.

        5. Cigarette consumption, as measured by cigarettes-per-day (CPD), will be lower for the
           RNC group than for the control group.

      Secondary hypotheses:

        1. Over the course of tapering and maintenance and at follow-up, interest in quitting will
           be higher in the RNC group compared to the control group.

        2. At follow-up, measures of cigarette consumption, nicotine intake, and exposure to
           tobacco smoke combustion constituents will be lower for the RNC group compared to the
           control group.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Health adults 18 and over
      
Biospecimen description: 
      Tissue (blood) and urine
    
Keywords: Smoking; Tobacco; Nicotine