Provoked Craving Relief Study by NRT
Condition: Smoking Cessation
Intervention: nicotine
Intervention description: nicotine in the form of a mouth strip, lozenge and gum
Intervention MeSH terms: Nicotine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 120.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: craving, provoked craving, smoking cessation, nicotine replacement therapy, NRT

Summary:

      This study is designed to assess the ability of the mint nicotine mouth strip to relieve
      provoked cigarette craving in light smokers compared to nicotine lozenge and nicotine gum.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Smoking Status: Current cigarette smokers who have smoked regularly for at least a
             year and smoke their first cigarette more than 30 minutes after waking up.

        Exclusion Criteria:

          -  Allergy/Intolerance: Known or suspected intolerance or hypersensitivity to nicotine
             (or closely related compounds) or any of the stated ingredients in formulation.

          -  Prior Concomitant Medication: a. Treatment with known enzyme altering agents (e.g.
             carbamazepine, phenytoin, cimetidine, sodium valporate) within 30 days of the craving
             provocation visit. b. Use of any prescription psychoactive medication (such as but not
             limited to antidepressants, antipsychotics, anxiolytics) within 14 days of the craving
             provocation visit. c. Use of any over-the-counter (OTC) medication that affects
             central nervous system such as antihistamines, sedating agents, or any compound that
             would have a sedating effect within 24 hours of the craving provocation visit. d. Use
             of any nicotine replacement therapy or any other treatment for smoking cessation (e.g.
             bupropion or varenicline) within one month of screening visit. e. Use of any nicotine
             containing products at any time during the Provocation/Treatment visit. f. Use of any
             medications noted in the exclusion criteria, or use of any product that would, in the
             opinion of the investigator, jeopardize the safety of the subject or impact on the
             validity of the study results.

          -  Any disease that, in the opinion of the investigator, may interfere with the
             absorption, metabolism or excretion of the study product. A medical history that, in
             the opinion of the investigator, might jeopardise the safety of the subject or the
             validity of the study results. For example, recent myocardial infarction or
             cerebrovascular accident (within 12 weeks of the screening visit), phenylketonuria,
             unstable or worsening angina pectoris, Prinzmetals angina or severe cardiac
             arrhythmia.

          -  Expired Carbon Monoxide (CO): Any subject whose CO level rises during the
             sequestration period (i.e., the subject's expired CO assessments immediately prior to
             the provoked craving paradigm are higher than the mean baseline CO assessment) and, in
             the opinion of the investigator, may have smoked during that time.

          -  Alcohol: Consumption of any alcoholic beverage within 24 hours of the craving
             provocation visit, as indicated by a positive breath alcohol test.