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

Phase 4

Completed

Brief Summary: 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: 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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Gum 4	Nicotine Gum	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
Gum 2	Nicotine Gum	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
Patch	Nicotine Patch	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Carbon Monoxide (CO)-Verified Smoking Reduction	Baseline to Week 24	Percentage of participants with carbon monoxide (CO)-verified reduction from baseline in number of cigarettes smoked per day (%)
Smoking Consumption Per Day	24 Weeks from last visit:	Number of cigarettes smoked by subjects reporting smoking since last visit - total during the day (for daily smokers)
Smoking Consumption Per Week	24 Weeks from last visit:	Number of cigarettes smoked by subjects reporting smoking since last visit - total during the the week (for non-daily smokers)
Point Prevalence Smoking Abstinence (PPSA)	24 Weeks	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.

Locations (6): People's Hospital affiliated to Beijing University
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Beijing, Beijing, China
No. 1 Hospital affiliated to Zhongshan University
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Guangzhou, Guangdong, China
Chang Zheng Hospital
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Shanghai, Shanghai, China
No. 1 Hospital affiliated to Guangzhou Medical University
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Guangzhou, Guangdong, China
Beijing ChaoYang Hospital
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Beijing, Beijing, China
Zhong Shan Hospital affiliated to Fudan University
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Shanghai, Shanghai, China