Evaluation of the Safety Profile, Quit and Reduction Rate After Nicorette® Gum and Patch Treatment

Study Overview
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Brief Summary
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To evaluate the safety, smoking cessation and reduction rate during 3 months of active nicotine replacement therapy (NRT) and a follow-up period of 3 months in smoking hospital physicians and staff who are motivated to quit

Detailed Description
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Using Nicorette® gum 2 mg, 4 mg and Nicorette® patch 5 mg/16 h, 10 mg/16 h, 15 mg/16 h to alleviate nicotine cravings and withdrawal symptoms and assist smoking cessation in smoking hospital physicians and staff who are motivated to quit. During the study, brief telephone consultation and SMS are provided as behavioral supports.

Official Title
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Evaluation of the Safety Profile, Quit and Reduction Rate After Nicorette® Gum and Patch Treatment

Conditions
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Tobacco Dependence

Intervention / Treatment
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* Drug: Nicotine Gum
* Drug: Nicotine Patch


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy males and females, aged 18 years or older Normal dental status and chewing ability for nicotine gum users; normal skin without excessive hair growth on tested areas for nicotine patch users Current daily smoker for at least two years Have a carbon monoxide (CO) level of at least 10 parts per million (ppm) after at least 15 smoke-free minutes Be motivated to stop smoking with the help of nicotine gum or patch treatment. Evidence of a personally signed and dated informed consent form indicating that the subject has been informed of all pertinent aspects of the trial Be willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures. Exclusion Criteria: Current use of other tobacco-containing products e.g. snuff, chewing tobacco, cigars, or pipes. Use of any other stop-smoking products (nicotine or non-nicotine) or treatment (hypnosis, acupuncture, etc) during the study i.e. during the last 6-month period. Unstable angina pectoris or myocardial infarction during the previous 3 months. Pregnancy, lactation or intended pregnancy. Any major metabolic disease, clinically important renal, hepatic disease. Suspected alcohol or drug abuse. Participation in other clinical trials in the previous three months, or during study participation. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and, in the judgment of the investigator, would make the subject inappropriate for entry into this trial.

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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gum 2<br>Nicotine Gum 2 mg for subjects smoking less than 20 cigarettes per day; 2 mg for 12 week treatments and followed by 12 week off-treatment follow-up. Recommend subject to use 8-12 pieces daily for first 8 weeks and 4-6 pieces daily the next 2 weeks, then reduce to 1-3 pieces each day in last 2 weeks | Drug: Nicotine Gum<br>* 2 mg or 4 mg for 12 week treatments and followed by 12 week off-treatment follow-up. Recommend subject to use 8-12 pieces daily for first 8 weeks and 4-6 pieces daily the next 2 weeks, then reduce to 1-3 pieces each day in last 2 weeks<br>* Other names: Nicorette® Gum;|
| Experimental: Gum 4<br>Nicotine Gum 4 mg for subjects smoking 20 or more cigarettes per day; 4 mg for 12 week treatments and followed by 12 week off-treatment follow-up. Recommend subject to use 8-12 pieces daily for first 8 weeks and 4-6 pieces daily the next 2 weeks, then reduce to 1-3 pieces each day in last 2 weeks | Drug: Nicotine Gum<br>* 2 mg or 4 mg for 12 week treatments and followed by 12 week off-treatment follow-up. Recommend subject to use 8-12 pieces daily for first 8 weeks and 4-6 pieces daily the next 2 weeks, then reduce to 1-3 pieces each day in last 2 weeks<br>* Other names: Nicorette® Gum;|
| Experimental: Patch<br>Nicotine Patch; Each will use 15 mg/16 h patch for the first 8 weeks, 10 mg/16 h for the following 2 weeks and 5 mg/16 h for the last 2 weeks. Then followed by 12 week off-treatment follow-up. | Drug: Nicotine Patch<br>* Each will use 15 mg/16 h patch for the first 8 weeks, 10 mg/16 h for the following 2 weeks and 5 mg/16 h for the last 2 weeks. Then followed by 12 week off-treatment follow-up.<br>* Other names: Nicorette® Patch;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment-Related Adverse Events | Percentage of subjects with treatment-related adverse events by preferred term, included if the percentage in any single arm was 1% or higher | 24 Weeks | 
| Self-Reported Smoking Reduction | Percentage of subjects self-reporting reduction from baseline in number of cigarettes smoked per day | 24 Weeks | 
| Smoking Abstinence | Continuous carbon monoxide (CO)-verified Smoking Abstinence from Quit day | 24 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Carbon Monoxide (CO)-Verified Smoking Reduction | Percentage of participants with carbon monoxide (CO)-verified reduction from baseline in number of cigarettes smoked per day (%) | Baseline to Week 24 | 
| Smoking Consumption Per Day | Number of cigarettes smoked by subjects reporting smoking since last visit - total during the day (for daily smokers) | 24 Weeks from last visit: | 
| Smoking Consumption Per Week | Number of cigarettes smoked by subjects reporting smoking since last visit - total during the the week (for non-daily smokers) | 24 Weeks from last visit: | 
| Point Prevalence Smoking Abstinence (PPSA) | Point Prevalence Smoking Abstinence since last visit. Point prevalence abstinence is defined as the percentage of former smokers who are not smoking at a particular point in time, typically at the time of assessment. | 24 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nicotine dependence, smoking cessation, NRT