Study to Determine the Efficacy and Safety of a Novel Nicotine Replacement Therapy
| Status: | Completed |
|---|---|
| Conditions: | Smoking Cessation, Tobacco Consumers |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - 85 |
| Updated: | 1/10/2019 |
| Start Date: | January 31, 2015 |
| End Date: | February 10, 2016 |
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.
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.
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