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

McNeil-PPC

Status and phase: Completed; Phase 3

Conditions: Tobacco Dependence

Treatments: Drug: Placebo; Drug: Nicotine Spray

Study type: Interventional

Funder types: Industry

Identifiers

NCT02355665

CO-140121222102-SCCT

Details and patient eligibility

About

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.

Enrollment: 1,198 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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1,198 participants in 2 patient groups, including a placebo group

Nicotine

Experimental group

Description:

Nicotine Spray

Treatment:

Drug: Nicotine Spray

Placebo

Placebo Comparator group

Description:

Placebo to match Nicotine spray

Treatment:

Drug: Placebo