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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1198 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2016-02-10

Brief Summary

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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.

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Detailed Description

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Conditions

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Tobacco Dependence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Nicotine

Nicotine Spray

Group Type EXPERIMENTAL

Nicotine Spray

Intervention Type DRUG

Nicotine Spray

Placebo

Placebo to match Nicotine spray

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo to match nicotine spray

Interventions

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Nicotine Spray

Intervention Type DRUG

Placebo

Placebo to match nicotine spray

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No