A Pilot Study to Evaluate the Efficacy and Safety of Ariva® Silver Wintergreen in Healthy Smokers

Star Scientific, Inc37 enrolled

Overview

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 an Ariva® 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.

Ariva WintergreenOTHER

Comparator product, a compressed dissolvable smokeless tobacco lozenge containing 2 mg nicotine 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 to be measured by the change in score on a craving questionnaire, from before to after product use.

Time frame: 90 minutes

Data from ClinicalTrials.gov

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