Oral Mucosal Effects In Adult Smokers Associated With Two Nicotine Lozenge Formulations

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).