Pilot Study to Evaluate the Safety and Efficacy of Ariva® Silver Wintergreen in Reducing Cigarette Craving in Smokers
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01337830|
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: Silver Wintergreen||Phase 1|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||111 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Randomized, Double-Blind, Crossover, Pilot Study to Evaluate the Safety and Efficacy of Ariva® Silver Wintergreen, a Smoking Aversive Lozenge, in Reducing Craving for a Cigarette in Daily Smokers|
|Study Start Date :||October 2010|
|Actual Primary Completion Date :||October 2010|
|Actual Study Completion Date :||October 2010|
Experimental: 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.
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: 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.
Other: Silver Wintergreen
Comparator product containing 6 mg silver salt and no tobacco (i.e., no nicotine), administered orally as a single dose.
- Effectiveness of Ariva® Silver Wintergreen lozenge on reducing craving for a cigarette in daily 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): NCT01337830
|United States, West Virginia|
|Martinsburg, West Virginia, United States, 25401|
|Principal Investigator:||Maria Varga, MD||Star Scientific, Inc|