NCT01337817

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

A Randomized, Double-Blinded, Active-Controlled, Crossover, Pilot Study to Evaluate the Efficacy and Safety of Ariva® Silver Wintergreen, a Smoking Aversive Lozenge, Containing Tobacco and Silver Salt - in Healthy Smokers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Star Scientific, Inc · Industry
• Sex: All
• Age: 23 Years – 72 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Tobacco Use Disorder
• Smoking

Interventions

Type	Name	Description
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	Ariva Wintergreen	Comparator product, a compressed dissolvable smokeless tobacco lozenge containing 2 mg nicotine administered orally as a single dose.

Timeline

• Start date: 2009-09-01
• Primary completion: 2009-09-01
• Completion: 2009-09-01
• First posted: 2011-04-19
• Last updated: 2014-10-24

Locations

1 site across 1 country: United States