Smoking, Tobacco Use Disorder
Conditions
Keywords
smoking, smokeless, aversion, nicotine, nicotine replacement
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.
Interventions
Study product containing 6 mg silver salt and 2 mg nicotine per dissolvable lozenge, administered orally as a single dose.
OTHERAriva Wintergreen
Comparator product, a compressed dissolvable smokeless tobacco lozenge containing 2 mg nicotine administered orally as a single dose.
Sponsors
Star Scientific, Inc
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
23 Years to 72 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effectiveness of Ariva® Silver Wintergreen lozenge on discouraging smoking in smokers | 90 minutes | Effectiveness to be measured by the change in score on a craving questionnaire, from before to after product use. |
Countries
United States
Outcome results
None listed