A Phase 1 interventional study of Ariva Silver Wintergreen and Placebo Wintergreen in Tobacco Use Disorder and Smoking, sponsored by Star Scientific, Inc. Completed at 1 site in United States. Open to participants aged 23 Years to 72 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-10-24.
Sponsored by Star Scientific, Inc · Phase 1 and Interventional
This is a study to determine the safety and effectiveness of silver salt in Ariva® Silver Wintergreen Lozenge on discouraging smoking, by its imparting an unfavorable taste to the smoker when tobacco is smoked.
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.
968 studies on the registry are indexed under Tobacco Use Disorder; 126 are open to participants now.
This study's enrollment of 43 is below the median of 89 across 851 interventional studies indexed under Tobacco Use Disorder.
Browse Tobacco Use Disorder studies →Star Scientific, Inc is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
Study product containing 6 mg silver salt and 2 mg nicotine per dissolvable lozenge, administered orally as a single dose.
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
Effectiveness measured by change in scores over time across several questionnaires.
Time frame: 90 minutes
This study is completed, as verified in Oct 2014. You cannot join it, but the record below documents what was studied.
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Star Scientific, Inc