A Pilot Study to Evaluate the Efficacy of Ariva® Silver Wintergreen, a Smoking Aversive Lozenge

This is a study to determine the safety and effectiveness of silver salt in Ariva® Silver Wintergreen Lozenge on discouraging smoking, by its imparting an unfavorable taste to the smoker when tobacco is smoked.

Each subject will be given an Ariva® Silver Wintergreen lozenge or a Placebo Wintergreen lozenge on a random basis.

Once the lozenge has dissolved in the mouth, subjects will smoke one of their own cigarettes, and will answer questions about the experience and their craving for a cigarette.

After a washout period, each subject will repeat the steps with the second type of lozenge.

• Tobacco Use Disorder
• Smoking

• Other: Ariva Silver Wintergreen
  Study product containing 6 mg silver salt and 2 mg nicotine per dissolvable lozenge, administered orally as a single dose.
• Other: Placebo Wintergreen
  Placebo Wintergreen lozenge containing no tobacco, nicotine, or silver salt, administered orally as a single dose.

• Experimental: Ariva Silver Wintergreen
  Subjects allow study product lozenge to dissolve in mouth, smoke a cigarette, then answer questionnaires about product taste and effect on desire to smoke.
  Intervention: Other: Ariva Silver Wintergreen
• Placebo Comparator: Placebo Wintergreen
  Subjects allow study placebo lozenge to dissolve in mouth, smoke a cigarette, then answer questionnaires about product taste and effect on desire to smoke.
  Intervention: Other: Placebo Wintergreen

Inclusion Criteria:

• healthy adult smoker
• smoking for at least 5 years
• smoking at least one (1) pack of cigarettes a day
• interest in quitting smoking

Exclusion Criteria:

• known allergy to silver or silver salts
• pregnant or breast-feeding
• current drug or alcohol abuse, and/or history of drug or alcohol dependence within 3 months of study