Evaluation of the Safety Profile, Quit and Reduction Rate After Nicorette® Gum and Patch Treatment
Condition: Tobacco Dependence
MeSH terms: Tobacco Use Disorder
Intervention: Nicotine Gum; Nicotine Patch
Intervention description: 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; 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 MeSH terms: Nicotine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 300.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: nicotine dependence, smoking cessation, NRT

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
    

Eligibility criteria:

        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.