Oral Mucosal Effects In Adult Smokers Associated With Two Nicotine Lozenge Formulations
Condition: Safety Issues
Intervention: Nicotine Bitartrate Lozenge 4mg; Nicotine Polacrilex 4Mg Lozenge
Intervention description: Test Product; Active Comparator
Intervention MeSH terms: Nicotine
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 100.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      To study the oral mucosal effects in adult smokers associated with the use of two Nicotine
      Lozenge formulations.
    

Eligibility criteria:

        Inclusion Criteria:

        Potential subjects who meet the following criteria at Screening may be included in the
        study.

          1. Sex and Age: Males and females aged at least 18 years and older.

          2. Informed of the nature of the study and have agreed to and are able to read, review,
             and sign the informed consent document prior to commencing any study specific
             procedures. The informed consent document will be written in English, therefore the
             volunteer must have the ability to read and communicate in English.

          3. Must have smoked at least 10 cigarettes per day for the previous 12 months prior to
             screening.

          4. Must smoke first cigarette within 30 minutes of waking up.

          5. Must be motivated to quit smoking upon enrollment into the study.

          6. Contraception: Females of childbearing potential who have been, in the opinion of the
             Investigator, practicing a reliable method of contraception for at least two months
             prior to study participation and must agree to remain on an acceptable method of
             contraception while participating in the study period using the study medication.
             Acceptable methods of contraception are hormonal birth control, intrauterine device,
             double barrier methods, vasectomized partner or abstinence.

          7. Females of childbearing potential will be required to undergo a serum (Screening) and
             urine (Day 0) pregnancy test (must be negative).

          8. Females of non-childbearing potential must be surgically sterile for at least three
             months prior to Screening or post-menopausal for at least two years.

          9. General health: All study participants must have good general health and no impairment
             that would impede or affect ability to participate in the study as deemed acceptable
             by the Investigator.

         10. Compliance: All study participants must understand and be willing to comply with all
             study procedures and restrictions.

         11. Consent: All study participants must demonstrate willingness to participate as
             evidenced by voluntary written informed consent and must have received a signed and
             dated copy of the informed consent form.

        Exclusion Criteria:

          1. Females who have a positive pregnancy test, are pregnant, breastfeeding, or intend to
             become pregnant during the course of the study.

          2. Nicotine use:

               1. Is unable/unwilling to stop using forms of tobacco (e.g., traditional cigarettes,
                  chewing tobacco, nicotine gels, cigars, snuff tobacco, nicotine patch and
                  electronic cigarettes) for the duration of the study.

               2. Is unable/unwilling to stop using other nicotine replacement therapy products
                  throughout the duration of the study.

          3. Disease: Has a medical history, which in the opinion of the investigator, would
             jeopardize the safety of the subject or impact the validity of the study results,
             e.g., known history of heart disease, recent myocardial infarction or cerebrovascular
             accident (i.e., within 12 weeks prior to enrollment), unstable angina, severe cardiac
             arrhythmia, diabetes or peptic ulcer.

          4. Demonstrates a reactive screen for Hepatitis B surface antigens, hepatitis C antibody,
             or HIV antibody.

          5. Oral condition:

               1. Has history of oral surgery (including extractions) within four weeks of
                  screening, operative dental work within seven days of screening, or a presence of
                  any clinically significant oral pathology (as determined by an oral health
                  professional - dentist or dental hygienist) including lesions, sores or
                  inflammation of the mouth which would interfere with study assessments or
                  confound the results.

               2. Has fixed retainers, orthodontic appliances, or either maxillary and/or
                  mandibular dentures or other appliances which may interfere with the placement of
                  the product.

               3. Has current or recurrent disease that could affect the site of application, the
                  action, absorption of the study treatment, or clinical assessment.

               4. Has severe gingivitis, periodontitis or rampant caries (extensive dental decay,
                  i.e., big/deep cavities, in many teeth), as diagnosed by an oral health
                  professional- dentist or dental hygienist.

               5. Has the presence of oral or peri-oral ulceration including herpetic lesions at
                  screening (subjects with these lesions may be re-examined at a subsequent
                  appointment and may be able to be admitted at a later date if the ulceration or
                  herpetic lesion heals) or Study Visit Day 0.

               6. Has elective dentistry scheduled during the study duration.

          6. Allergy/Intolerance:

               1. Has a known or suspected intolerance or hypersensitivity to the study materials
                  (or closely-related compounds) or any of their stated ingredients.

               2. Has a known genetic deficiency with an inability to metabolize aspartame or
                  phenylalanine or has been diagnosed with phenylketonuria.

          7. Clinical Study Participation:

               1. Participation in another clinical study or receipt of an investigational drug
                  within 30 days of the screening visit at the start of the study.

               2. Previous participation in this study.

          8. Substance abuse:

               1. Current or recent (within two years of screening) history of drug or alcohol
                  abuse, misuse, physical or psychological dependence.

               2. Demonstrates a positive alcohol breath test.

               3. Demonstrates a positive urine drug screen without disclosure of corresponding
                  prescribed concomitant medication(s) at Screening and Study Visit Day 0.

          9. Urine glucose:

             a) Positive glucose urine screen.

         10. Personnel:

               1. Is an employee of the Sponsor or the study site.

               2. Is a member of the same household as another subject in this trial.

         11. Use of all over the counter (OTC) and prescription (Rx) lozenges after starting the
             study (Day 0 and onward).