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

Star Scientific, Inc43 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

QUADRUPLE

Enrollment

Conditions

Tobacco Use Disorder Smoking

Interventions

Ariva Silver WintergreenOTHER

Study product containing 6 mg silver salt and 2 mg nicotine per dissolvable lozenge, administered orally as a single dose.

Placebo WintergreenOTHER

Placebo Wintergreen lozenge containing no tobacco, nicotine, or silver salt, administered orally as a single dose.

Eligibility

Sex: ALLMin age: 23 YearsMax age: 72 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Comfort Inn

Martinsburg, West Virginia, United States

Outcomes

Primary Outcomes

Effectiveness of Ariva® Silver Wintergreen lozenge on discouraging smoking in smokers

Effectiveness measured by change in scores over time across several questionnaires.

Time frame: 90 minutes

Data from ClinicalTrials.gov

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