A Pilot Study to Evaluate the Efficacy and Safety of Ariva® Silver Wintergreen in Healthy Smokers
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|ClinicalTrials.gov Identifier: NCT01337817|
Recruitment Status : Completed
First Posted : April 19, 2011
Last Update Posted : October 24, 2014
|Condition or disease||Intervention/treatment||Phase|
|Tobacco Use Disorder Smoking||Other: Ariva Silver Wintergreen Other: Ariva Wintergreen||Phase 1|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||37 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||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|
|Study Start Date :||September 2009|
|Actual Primary Completion Date :||September 2009|
|Actual Study Completion Date :||September 2009|
Experimental: 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.
Other: Ariva Silver Wintergreen
Study product containing 6 mg silver salt and 2 mg nicotine per dissolvable lozenge, administered orally as a single dose.
Active Comparator: 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.
Other: Ariva Wintergreen
Comparator product, a compressed dissolvable smokeless tobacco lozenge containing 2 mg nicotine administered orally as a single dose.
- Effectiveness of Ariva® Silver Wintergreen lozenge on discouraging smoking in smokers [ Time Frame: 90 minutes ]Effectiveness to be measured by the change in score on a craving questionnaire, from before to after product use.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01337817
|United States, West Virginia|
|Martinsburg, West Virginia, United States, 25401|
|Principal Investigator:||Maria Varga, MD||Star Scientific, Inc|