Using Smokeless Tobacco Products With Lower Nicotine Levels to Reduce Negative Effects of Smokeless Tobacco Use
Condition: Tobacco Use Disorder
MeSH terms: Tobacco Use Disorder
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Though spit tobacco is smokeless, it still affects the cardiovascular system and may be
      associated with heart disease, stroke, and high blood pressure. This study will assess the
      effectiveness of limiting smokeless tobacco (ST) nicotine intake in reducing levels of
      exposure to tobacco and associated toxicity, as well as enhancing motivation to either quit
      or sustain lower levels of nicotine intake.
    

Detailed description: 
      Spit tobacco presents as many health risks to its users as smoking tobacco. It affects the
      cardiovascular system and may be associated with heart disease, stroke, and high blood
      pressure. Long-term effects of spit tobacco use include tooth abrasion, gum recession, mouth
      disease, bone loss in the jaw, yellowing of the teeth, and chronic bad breath. Although a
      significant number of ST users recognize the importance of quitting, many either do not want
      to quit or feel it is impossible. For these individuals, tobacco reduction may be an
      important transitional goal, either prior to quitting, or as a treatment endpoint; however,
      approaches to help ST users reach this goal have not been studied. This study will assess the
      effectiveness of limiting ST nicotine intake in reducing levels of exposure to tobacco and
      associated toxicity, as well as enhancing motivation to either quit or sustain lower levels
      of nicotine intake.

      Participants in this open-label study will be randomly assigned to one of three treatment
      conditions: switching to an ST brand with less concentrated nicotine and controlling for ST
      use; switching to an ST brand with less concentrated nicotine, combined with no limit on ST
      intake; or continued use of usual ST brand with no limit on intake (control group).
      Participants in both brand-switching conditions will use ST brands that have 50% less
      nicotine than their usual ST brands for the first 4 weeks. For the next 4 weeks, participants
      in the brand-switching conditions will use ST brands that have 75% less nicotine that their
      usual ST brands. Study visits will ocur once weekly during the 8-week treatment period. The
      number of participants who do not complete treatment, reduce nicotine intake, or quit
      completely will be assessed at Week 8 and at follow-up visits, which will be held 12 and 26
      weeks following the completion of treatment.
    

Intervention name(s): Lower Nicotine Smokeless Tobacco Product; Behavioral Counseling
Intervention type(s): Other; Other
Intervention description(s): Skoal for 50% reduction;Skoal bandits for 75% reduction.; Behavioral counseling alone for reduction in tobacco use.
Other intervention name(s): Skoal and Skoal Bandits
Intervention MeSH terms: Lobeline; Nicotine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Brand Switching, smokeless tobacco use