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

Phase 1

Completed

• Conditions: Tobacco Use Disorder; Smoking
• Interventions: Other: Ariva® Silver Wintergreen; Other: Silver Wintergreen

• Registration Number: NCT01337830
• Lead Sponsor: Star Scientific, Inc

Brief 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.

Study Timeline

• Study Start: 2010-10
• Primary Completion: 2010-10
• Study Completion: 2010-10
• Study First Submitted: 2011-04-14
• Study First Submitted QC: 2011-04-15
• Study First Posted: 2011-04-19
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-23
• Last Update Posted: 2014-10-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 111

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Ariva® Silver Wintergreen	Ariva® Silver Wintergreen	Subjects allow study product lozenge to dissolve in the mouth, smoke a cigarette, then answer questionnaires about the effect of the product on both their desire to smoke and on cigarette taste.
Silver Wintergreen	Silver Wintergreen	Subjects allow comparator product lozenge to dissolve in the mouth, smoke a cigarette, then answer questionnaires about the effect of the product on both their desire to smoke and on cigarette taste.

Primary Outcome Measures

Name	Time	Method
Effectiveness of Ariva® Silver Wintergreen lozenge on reducing craving for a cigarette in daily smokers	90 minutes	Effectiveness to be measured by the change in score on a craving questionnaire, from before to after product use.

Trial Locations

Locations (1)

Comfort Inn; 🇺🇸 Martinsburg, West Virginia, United States