Efficacy and Safety Study of Nicotine Mint Lozenge (2mg and 4mg) in Smoking Cessation
Condition: Smoking
Intervention: Nicotine; Placebo
Intervention description: 2 mg or 4 mg nicotine lozenge; placebo lozenge
Intervention MeSH terms: Nicotine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 723.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: smoking cessation; nicotine lozenge; nicotine replacement therapy

Summary:

      A multi-center, randomized, double-blind, placebo-controlled, 4-arm clinical study to
      evaluate efficacy and safety of nicotine lozenge (2mg and 4mg) in smoking cessation in adult
      cigarette smokers who are motivated to quit smoking. Successful quitters or participants who
      smoke occasionally will be followed up after week 24 till 12 months.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant must be 18 years of age or older;

          -  Participant is motivated in smoking cessation using nicotine mint lozenge;

          -  Participant has the habit of smoking regularly every day for at least 1 year;

          -  Participant is able to read and provide written informed consent.

        Exclusion Criteria:

          -  Participant uses other forms of tobacco other than cigarettes such as pipes, cigars,
             snuff, or smokeless tobacco within 30 days of entry into the study;

          -  Participant uses other nicotine delivery system such as nicotine gum, nicotine patch,
             nicotine inhaler, or nicotine nasal spray etc. within 30 days of study entry;

          -  Participant smoke any other substance within 30 days of study entry (such as cannabis,
             cocaine, heroin, ice drug, herbal cigarettes etc);

          -  The participant has a past history of alcohol or drug abuse;

          -  Participants use other smoking cessation aids (including bupropion, varenicline,
             traditional Chinese medicines such as herbals, acupuncture, consultation etc), within
             30 days of study entry.;

          -  Participant is currently involved in another clinical trial or has used any
             investigational medication within 30 days of study entry; Any previous participation
             in this study;

          -  Participant is a member of the same household as another clinical subject. Subject is
             a relative of study site staff or member of the study staff;

          -  Participant is pregnant or breast-feeding, or has childbearing potential but refusing
             taking medical contraception measures (within first 24 weeks during study). (Note: All
             female subjects with childbearing potential must take urine pregnancy test before
             entry the study, only negative result subject is permitted to this study.);

          -  Participants who have heart and cerebral vascular disease not stable or controlled by
             medication or have an irregular heartbeat or have had a heart attack within the last 3
             months;

          -  Participants with poorly controlled high blood pressure by medications, systolic BP
             greater than or equal to 140mmHg, diastolic BP greater than or equal to 90mmHg after
             administration;

          -  Participants having hyperthyroidism or current application of insulin for diabetes;

          -  Participants having myocardial infarction or cerebral vascular accidents recently
             (within the past 3 months);

          -  Participants who are unable to fulfill study requirements in relation to conforming to
             the visit schedule;

          -  Participants who are allergy to Aspartame or Phenylpyruvic acid (an edulcorant is
             widely used in foods and drinks)，or have diagnosed with Phenylketonuria;

          -  The other clinically significant pulmonary, gastrointestinal, liver, neurological,
             renal or haematological abnormalities.( unstable or worsening angina pectoris,
             Prinzmetal's angina, nerve or circulatory problems, rheumatoid arthritis, moderate and
             severe COPD);

          -  A medical history that, in the opinion of the investigator, might jeopardize the
             safety of the subject or the validity for the study results.