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
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Star Scientific, Inc
- Enrollment
- 37
- Locations
- 2
- Primary Endpoint
- Effectiveness of Ariva® Silver Wintergreen lozenge on discouraging smoking in smokers
Study Overview
Brief Summary
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.
Detailed Description
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 23 Years to 72 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •healthy adult smoker
- •smoking for at least 5 years
- •smoking at least one (1) pack of cigarettes a day
- •interest in quitting smoking
Exclusion Criteria
- •known allergy to silver or silver salts
- •pregnant or breast-feeding
- •current drug or alcohol abuse, and/or history of drug or alcohol dependence within 3 months of study
Outcomes
Primary Outcomes
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.
Secondary Outcomes
No secondary outcomes reported