Comparison Across Treatment Conditions to Reduce Smokeless Tobacco Use
Condition: Tobacco Use Disorder
MeSH terms: Tobacco Use Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      Smokeless tobacco (ST), which includes both chewing tobacco and snuff, has health risks
      associated with its use. While treatment programs that focus on stopping tobacco use may be
      effective, past research has shown that interventions that specifically focus on reducing
      tobacco use may be equally effective and may motivate individuals to eventually quit using
      tobacco. This study will compare the effectiveness of a ST reduction treatment program versus
      a usual tobacco cessation treatment program (immediate cessation) for reducing tobacco use in
      ST users.
    

Detailed description: 
      Individuals who use ST are at increased risk for cancer or dying from cardiovascular disease.
      Other long-term effects include tooth abrasion, gum recession, and loss of bone in the jaw.
      Many individuals who use ST recognize the health risks associated with ST, but either do not
      want to quit or feel that it is impossible to quit. For these individuals, tobacco reduction
      may be an important transitional goal, either prior to quitting or as a treatment endpoint.
      By participating in a tobacco reduction program, these individuals may be motivated to
      eventually stop using tobacco altogether. The purpose of this study is to compare a ST
      reduction treatment program versus a standard tobacco cessation treatment program (immediate
      cessation) for reducing tobacco use in ST users.

      This study will enroll regular users of ST. Participants will be randomly assigned to either
      a tobacco reduction program or to usual care, a standard tobacco cessation program during the
      first telephone contact. At the first clinic visit, participants assigned to the tobacco
      Reduction Group will replace their usual brand of ST with one of two options: an ST brand
      with less nicotine or nicotine lozenge. Participants will be encouraged to reduce their
      nicotine intake by at least 50% the first two weeks and encouraged to further reduce their
      nicotine intake in the following 4 weeks. Participants assigned to the Usual Care Group will
      be advised to quit and will be asked to set a quit date within two weeks. Telephone
      counseling, ideas on methods for sustaining cessation, and a self-help manual will also be
      provided along with a 2 week supply of nicotine patches. Study visits will occur at 2, 4, 8,
      12, 26, and 32 (for reduction group) weeks. Outcome assessments will include vital signs,
      physiological measures related to tobacco use, levels of nicotine reduction, tobacco use
      status, and measures of motivation and self-efficacy to quit.
    

Intervention name(s): Usual Care Group; Reduction Group
Intervention type(s): Drug; Other
Intervention description(s): Nicotine replacement therapy; Subject selects preferred method for reduction.
Other intervention name(s): 21 mg Nicotine Patch; Nicoderm; Commit Nicotine Lozenge or; Reduced nicotine smokeless tobacco products (Skoal, Skoal Bandits)
Intervention MeSH terms: Lobeline; Nicotine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Nicotine Dependence; Tobacco Dependence