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

• Treatment-Related Adverse Events [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
  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 [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
  Percentage of subjects self-reporting reduction from baseline in number of cigarettes smoked per day
• Smoking Abstinence [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
  Continuous carbon monoxide (CO)-verified Smoking Abstinence from Quit day

• Carbon Monoxide (CO)-Verified Smoking Reduction [ Time Frame: Baseline to Week 24 ] [ Designated as safety issue: No ]
  Percentage of participants with carbon monoxide (CO)-verified reduction from baseline in number of cigarettes smoked per day (%)
• Smoking Consumption Per Day [ Time Frame: 24 Weeks from last visit: ] [ Designated as safety issue: No ]
  Number of cigarettes smoked by subjects reporting smoking since last visit - total during the day (for daily smokers)
• Smoking Consumption Per Week [ Time Frame: 24 Weeks from last visit: ] [ Designated as safety issue: No ]
  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) [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
  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.

• Self-reported smoking cessation rate verified by CO level [ Time Frame: Weeks 2, 6, 8, 10, 12 and 24 ] [ Designated as safety issue: No ]
• Reduction of self-reported daily smoked cigarettes compared to baseline [ Time Frame: Weeks 2,6,8,10,12 and 24 ] [ Designated as safety issue: No ]

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

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.

• Drug: Nicotine Gum
  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
  Other Name: Nicorette® Gum
• Drug: 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.
  Other Name: Nicorette® Patch

• Experimental: Gum 2
  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
  Intervention: Drug: Nicotine Gum
• Experimental: Gum 4
  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
  Intervention: Drug: Nicotine Gum
• Experimental: 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.
  Intervention: Drug: Nicotine Patch

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.