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Study to Determine the Efficacy and Safety of a Novel Nicotine Replacement Therapy

CompletedPhase 3

Sponsor: McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.

Conditions: Tobacco Dependence

Interventions: Nicotine Spray, Placebo

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 85 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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.

Locations (8)

Scottsdale, Arizona, United States
Burbank, California, United States
Chicago, Illinois, United States
College Park, Maryland, United States
Akron, Ohio, United States
Cincinnati, Ohio, United States
Dallas, Texas, United States
Salt Lake City, Utah, United States