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

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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.
We found this trial at
8
sites
Scottsdale, Arizona 85259
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Scottsdale, AZ
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Akron, Ohio 44311
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Akron, OH
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Burbank, California 91505
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Burbank, CA
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Chicago, Illinois 60654
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Chicago, IL
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Cincinnati, Ohio 45249
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Cincinnati, OH
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College Park, Maryland 20742
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College Park, MD
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Dallas, Texas 75231
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Dallas, TX
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Salt Lake City, Utah 84107
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Salt Lake City, UT
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