Efficacy and Safety Following Use of a Novel Nicotine Replacement Therapy

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

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

Official Title
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Efficacy and Safety Following Use of a Novel Nicotine Replacement Therapy. A Multicenter, Randomized, Double Blind, Placebo Controlled, Parallel Group, 52 Week Study in Smokers Motivated to Quit.

Conditions
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Smoking Cessation

Intervention / Treatment
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* Drug: Nicotine
* Drug: Placebo


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nicotine<br>Nicotine | Drug: Nicotine<br>* Nicotine administered using novel NRT user instructions<br>* Other names: NRT;|
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo<br>* Placebo administered using novel NRT user instructions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-reported continuous abstinence from smoking verified by exhaled CO levels of less than 10 ppm. |  | at weeks 2, 6, 24 and 52 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-reported continuous abstinence from smoking, verified by exhaled CO levels of less than 10 ppm. |  | weeks 2, 4, 8, 12, 16, and 20 | 
| Self-reported 7-day point prevalence abstinence from smoking verified by exhaled CO levels of less than 10 ppm. |  | weeks 4, 6, 8, 12, 16, 20, 24, and 52 | 
| Ratings of craving/urge to smoke and withdrawal symptoms. |  | baseline to 24 weeks | 
| Cotinine levels in saliva. |  | baseline, and weeks 2, 6, 12 and 24 | 
| Product acceptability |  | weeks 1, 6 and 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Smoking Cessation