Controlled Study of the Ability of a Smokefree Tobacco Product to Increase the Quit Rate Among Cigarette Smokers
Condition: Cigarette Smoking
Study type: Interventional
Phase: Phase 4

Summary: 
      The study aims to assess if use of a low-nitrosamine, Swedish, smokefree tobacco product for
      oral use ("snus") can increase the quit rate among cigarette smokers who wish to stop smoking
    

Detailed description: 
      In a multicenter, double-blind, placebo-controlled setting, participants are randomly
      allocated to either a smokefree, oral tobacco product or a non-tobacco, non-nicotine placebo
      product with identical flavoring and physical appearance. The study consists of three phases:
      Study Product Test Period (4 weeks), Intervention Phase (12 weeks), and a Follow-Up Phase (12
      weeks). The participants are all cigarette smokers who are motivated to quit. They are
      encouraged to gradually substitute as many cigarettes as possible with study products during
      the Study Product Test Period and to refrain from all cigarettes at the latest by the first
      day of Week 5. Use of study products will continue during the 12 week Intervention Phase. The
      participants are encouraged to cut down on use of study products during the last 3 weeks to
      avoid a too abrupt ending of nicotine intake.

      All subjects are encouraged to continue in the study for clinical follow-up independent of
      smoking status although use of study products is discontinued during the Follow-Up Phase. If
      a subject has managed to quit smoking during the Intervention Phase but there is an imminent
      danger of smoking relapse during the Follow-Up Phase, that subject is informed that use of
      nicotine replacement therapy or a smokefree tobacco product is a better option in terms of
      health risks than a smoking relapse.
    

Intervention name(s): Low-nitrosamine smokefree tobacco product for oral use; Non-tobacco, non-nicotine placebo product
Intervention type(s): Drug; Other
Intervention description(s): Smokeless tobacco in paper sachets containing 1.0 or 0.5 g of the product. Usage ad libitum. Recommended dosages: 10-24 sachets per day (1.0 g sachets). Among participants who typically smoke >15-20 cigarettes per day and/or has a Fagerström score of 7 or higher, the recommended maximum number of sachets per day is 30. For participants who use small sachets (0.5 g) the recommended daily use is double compared that of 1.0 g sachets.; Placebo product in paper sachets containing 1.0 or 0.5 g. Product made of cocoa bean fibers and oat fibers. Usage ad libitum. Recommended dosages: 10-24 sachets per day (1.0 g sachets). Among participants who typically smoke >15-20 cigarettes per day and/or has a Fagerström score of 7 or higher, the recommended maximum number of sachets per day is 30. For participants who use small sachets (0.5 g) the recommended daily use is double compared that of 1.0 g sachets.
Other intervention name(s): Swedish tobacco-based smokefree product for oral use ("General"-type Swedish "snus"); Placebo "snus" ("Onico"-type product)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Smoking; Smoking cessation; Smokeless tobacco; Snus