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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Tobacco Use Disorder, Smoking

Intervention / Treatment
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* Other: Ariva Silver Wintergreen
* Other: Ariva Wintergreen


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 23 Years
Maximum Age: 72 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ariva Silver Wintergreen<br>Subjects allow study product lozenge to dissolve in mouth, smoke a cigarette, then answer questionnaires about product taste and effect on desire to smoke. | Other: Ariva Silver Wintergreen<br>* Study product containing 6 mg silver salt and 2 mg nicotine per dissolvable lozenge, administered orally as a single dose.<br>|
| Active Comparator: Ariva Wintergreen<br>Subjects allow study comparator lozenge to dissolve in mouth, smoke a cigarette, then answer questionnaires about product taste and effect on desire to smoke. | Other: Ariva Wintergreen<br>* Comparator product, a compressed dissolvable smokeless tobacco lozenge containing 2 mg nicotine administered orally as a single dose.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness of Ariva® Silver Wintergreen lozenge on discouraging smoking in smokers | Effectiveness to be measured by the change in score on a craving questionnaire, from before to after product use. | 90 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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smoking, smokeless, aversion, nicotine, nicotine replacement