A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Study Using a Naturalistic Clinical Model to Measure the Efficacy and Safety of a Novel Nicotine Replacement Therapy in Smokers Motivated to Quit
A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Study Using a Naturalistic Clinical Model to Measure the Efficacy and Safety of a Novel Nicotine Replacement Therapy in Smokers Motivated to Quit
The purpose of this study is to assess the efficacy and safety of a novel nicotine product for continuous abstinence from smoking. Efficacy of product will be evaluated by assessments of self-reported abstinence, verified by exhaled carbon monoxide (CO) levels.
Inclusion Criteria:
Subjects must be males or females 18-85 years of age who currently smoke cigarettes daily and are willing to stop smoking
Exclusion Criteria:
History of cardiovascular disease, stomach ulcer or diabetes unless physician's written approval is obtained.
Use of other forms of tobacco/nicotine containing products other than cigarettes within 30 days before baseline visit.
Use of nicotine replacement therapies or other smoking cessation medicines/non-drug therapies within 30 days before the baseline visit.
Pregnancy or intending to become pregnant.
Hypersensitivity to the product, history of alcohol or substance abuse.