A Pilot Study to Evaluate the Efficacy of Ariva® Silver Wintergreen, a Smoking Aversive Lozenge
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|ClinicalTrials.gov Identifier: NCT01336816|
Recruitment Status : Completed
First Posted : April 18, 2011
Last Update Posted : October 24, 2014
|Condition or disease||Intervention/treatment||Phase|
|Tobacco Use Disorder Smoking||Other: Ariva Silver Wintergreen Other: Placebo Wintergreen||Phase 1|
Each subject will be given an Ariva® Silver Wintergreen lozenge or a Placebo 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 :||43 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Randomized, Double-Blinded, Placebo-Controlled, Crossover, Pilot Study to Evaluate the Efficacy of Ariva® Silver Wintergreen, a Smoking Aversive Lozenge, Containing Tobacco and Silver Salt - in Healthy Smokers|
|Study Start Date :||July 2009|
|Actual Primary Completion Date :||July 2009|
|Actual Study Completion Date :||July 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.
Placebo Comparator: Placebo Wintergreen
Subjects allow study placebo lozenge to dissolve in mouth, smoke a cigarette, then answer questionnaires about product taste and effect on desire to smoke.
Other: Placebo Wintergreen
Placebo Wintergreen lozenge containing no tobacco, nicotine, or silver salt, administered orally as a single dose.
- Effectiveness of Ariva® Silver Wintergreen lozenge on discouraging smoking in smokers [ Time Frame: 90 minutes ]Effectiveness measured by change in scores over time across several questionnaires.
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): NCT01336816
|United States, West Virginia|
|Martinsburg, West Virginia, United States, 25401|
|Principal Investigator:||Maria Varga, MD||Star Scientific, Inc|