A Pilot Study to Evaluate the Efficacy of Ariva® Silver Wintergreen, a Smoking Aversive Lozenge
|Tobacco Use Disorder Smoking||Other: Ariva Silver Wintergreen Other: Placebo Wintergreen||Phase 1|
|Study Design:||Allocation: Randomized
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|
- 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.
|Study Start Date:||July 2009|
|Study Completion Date:||July 2009|
|Primary Completion Date:||July 2009 (Final data collection date for primary outcome measure)|
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01336816
|United States, West Virginia|
|Martinsburg, West Virginia, United States, 25401|
|Principal Investigator:||Maria Varga, MD||Star Scientific, Inc|