NCT01337830

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

A Randomized, Double-Blind, Crossover, Pilot Study to Evaluate the Safety and Efficacy of Ariva® Silver Wintergreen, a Smoking Aversive Lozenge, in Reducing Craving for a Cigarette in Daily Smokers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 111 (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 Ariva® Silver Wintergreen lozenge on reducing craving for a cigarette in daily smokers.

Detailed description

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.

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	Silver Wintergreen	Comparator product containing 6 mg silver salt and no tobacco (i.e., no nicotine), administered orally as a single dose.

Timeline

• Start date: 2010-10-01
• Primary completion: 2010-10-01
• Completion: 2010-10-01
• First posted: 2011-04-19
• Last updated: 2014-10-24

Locations

1 site across 1 country: United States