Pilot Study to Evaluate the Safety and Efficacy of Ariva® Silver Wintergreen in Reducing Cigarette Craving in Smokers

Star Scientific, Inc111 enrolled

Overview

Study to determine the safety and effectiveness of Ariva® Silver Wintergreen lozenge on reducing craving for a cigarette in daily smokers.

Each subject will be given an Ariva® Silver Wintergreen lozenge or a Silver Wintergreen lozenge, which contains only silver salt, 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

111

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.

Silver WintergreenOTHER

Comparator product containing 6 mg silver salt and no tobacco (i.e., no 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 reducing craving for a cigarette in daily 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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