Controlled Study of the Ability of a Smokefree Tobacco Product to Increase the Quit Rate Among Cigarette Smokers

• Minnesota Nicotine Withdrawal Scale [ Time Frame: Baseline, week 6, 10, 16 and 28 ] [ Designated as safety issue: No ]
• Fagerström Test for Nicotine Dependence [ Time Frame: Baseline, week 16 and 28 ] [ Designated as safety issue: No ]
• Biomarkers [ Time Frame: Baseline, week 6, 16, and 28 ] [ Designated as safety issue: Yes ]
• Point prevalence smoking cessation [ Time Frame: 6, 16, 28 weeks ] [ Designated as safety issue: No ]
  7-day point prevalence smoking cessation verified by CO in exhaled air of 8 ppm or less
• Continuous smoking cessation [ Time Frame: 6-16 weeks ] [ Designated as safety issue: No ]
  Continuous cessation according to self-report and CO in exhaled air of 8 ppm or less att all clinical visits

• Point-prevalence smoking cessation rates (during preceding week) confirmed by self-report and expired air carbon monoxide less or equal than 8 ppm [ Time Frame: Week 6-28 ] [ Designated as safety issue: No ]
• Minnesota Nicotine Withdrawal Scale [ Time Frame: Baseline, week 6, 10, 16 and 28 ] [ Designated as safety issue: No ]
• Fagerström Test for Nicotine Dependence [ Time Frame: Baseline, week 16 and 28 ] [ Designated as safety issue: No ]
• Biomarkers [ Time Frame: Baseline, week 6, 16, and 28 ] [ Designated as safety issue: Yes ]

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

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.

• Drug: Low-nitrosamine smokefree tobacco product for oral use
  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.
  Other Names:

  • Swedish tobacco-based smokefree product for oral use ("General"-type Swedish "snus")
  • Placebo "snus" ("Onico"-type product)
• Other: Non-tobacco, non-nicotine placebo product
  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.

• Experimental: 1
  Tobacco-based, smokefree product
  Intervention: Drug: Low-nitrosamine smokefree tobacco product for oral use
• Placebo Comparator: 2
  Non-tobacco, non-nicotine placebo product
  Intervention: Other: Non-tobacco, non-nicotine placebo product

Inclusion Criteria:

• Cigarette smoker who smoke more than 9 cigarettes per day (average during past month)
• Daily smoking more than 1 year
• Motivated to quit smoking using a smokefree tobacco product
• Good general health

Exclusion Criteria:

• Use of smokefree/smokeless tobacco during past 6 months or any type of pharmaceutical product for smoking cessation during past 3 months
• Unable to refrain from nicotine replacement therapy during the study
• Current oral condition that could be made worse by study interventions
• History of clinically significant renal, hepatic, neurological, or chronic pulmonary disease that in the judgement of the investigator might preclude participation
• History of significant cardiovascular disease, including myocardial infarction, within the last 3 months, significant cardiac arrythmias, or poorly controlled hypertension that in the judgement of the investigator might preclude participation
• History of alcohol or substance abuse other than cigarette smoking within the past year