Efficacy and Safety Following Use of a Novel Nicotine Replacement Therapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

479 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2010-06-30

Brief Summary

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A comparison of a novel nicotine replacement therapy and placebo treatment in smokers motivated to quit smoking.

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Detailed Description

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Efficacy and safety study following use of a novel nicotine replacement therapy.

Conditions

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Smoking Cessation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Nicotine

Group Type EXPERIMENTAL

Nicotine

Intervention Type DRUG

Nicotine administered using novel NRT user instructions

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo administered using novel NRT user instructions

Interventions

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Nicotine

Nicotine administered using novel NRT user instructions

Intervention Type DRUG

Placebo

Placebo administered using novel NRT user instructions

Intervention Type DRUG

Other Intervention Names

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NRT

Eligibility Criteria

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Inclusion Criteria

* 18 years or older male and female cigarette smokers motivated and willing to stop smoking
* Female participants of child-bearing potential should use a medically acceptable means of birth control.
* Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study and consents to participate.

Exclusion Criteria

* Unstable angina pectoris or myocardial infarction during the previous 3 months.
* Pregnancy, lactation or intended pregnancy (non-pregnancy will be verified by urine pregnancy test for female participants of child-bearing potential).
* Participation in other clinical trials within the previous three months and during study participation.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No