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

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.

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