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

Phase 4

Completed

Interventions: Drug: Low-nitrosamine smokefree tobacco product for oral use
Other: Non-tobacco, non-nicotine placebo product

Brief 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
1	Low-nitrosamine smokefree tobacco product for oral use	Tobacco-based, smokefree product in pouch format for oral use, pouch size 1.0 or 0.5 g to be used ad libitum by participants
2	Non-tobacco, non-nicotine placebo product	Non-tobacco, non-nicotine placebo product in pouch format for oral use, pouch size 1.0 g or 0.5 g, to be used ad libitum by the participants

Primary Outcome Measures

Name	Time	Method
Continuous Rate of Smoking Cessation by Self-report and Confirmed by Expired Air Carbon Monoxide Less or Equal Than 8 Ppm	Week 6-28

Secondary Outcome Measures

Name	Time	Method
Minnesota Nicotine Withdrawal Scale	Baseline, week 6, 10, 16 and 28
Fagerström Test for Nicotine Dependence	Baseline, week 16 and 28
Biomarkers	Baseline, week 6, 16, and 28
Point Prevalence Smoking Cessation	6, 16, 28 weeks	7-day point prevalence smoking cessation verified by CO in exhaled air of 8 ppm or less
Continuous Smoking Cessation	6-16 weeks	Continuous cessation according to self-report and CO in exhaled air of 8 ppm or less att all clinical visits