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