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

Phase 1

Completed

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

• Registration Number: NCT01337817
• Lead Sponsor: Star Scientific, Inc

Brief 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.

Study Timeline

• Study Start: 2009-09
• Primary Completion: 2009-09
• Study Completion: 2009-09
• 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: 37

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 Wintergreen	Ariva Wintergreen	Subjects allow study comparator lozenge to dissolve in mouth, smoke a cigarette, then answer questionnaires about product taste and effect on desire to smoke.
Ariva Silver Wintergreen	Ariva Silver Wintergreen	Subjects allow study product lozenge to dissolve in mouth, smoke a cigarette, then answer questionnaires about product taste and effect on desire to smoke.

Primary Outcome Measures

Name	Time	Method
Effectiveness of Ariva® Silver Wintergreen lozenge on discouraging smoking in 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