Cigarette Smoking Clinical Trial
Official title:
A Controlled Study of the Ability of a Traditional Swedish Smokeless Tobacco Product ("Snus") to Increase the Quit Rate Among Cigarette Smokers Who Wish to Stop Smoking
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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