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Study to determine the safety and effectiveness of Ariva® Silver Wintergreen lozenge on reducing craving for a cigarette in daily smokers.
Each subject will be given an Ariva® Silver Wintergreen lozenge or a Silver Wintergreen lozenge, which contains only silver salt, 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ariva® Silver Wintergreen | Experimental | Subjects allow study product lozenge to dissolve in the mouth, smoke a cigarette, then answer questionnaires about the effect of the product on both their desire to smoke and on cigarette taste. |
|
| Silver Wintergreen | Active Comparator | Subjects allow comparator product lozenge to dissolve in the mouth, smoke a cigarette, then answer questionnaires about the effect of the product on both their desire to smoke and on cigarette taste. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ariva® Silver Wintergreen | Other | Study product containing 6 mg silver salt and 2 mg nicotine per dissolvable lozenge, administered orally as a single dose. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness of Ariva® Silver Wintergreen lozenge on reducing craving for a cigarette in daily smokers | Effectiveness to be measured by the change in score on a craving questionnaire, from before to after product use. | 90 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maria Varga, MD | Star Scientific, Inc | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Comfort Inn | Martinsburg | West Virginia | 25401 | United States |
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| ID | Term |
|---|---|
| D014029 | Tobacco Use Disorder |
| D012907 | Smoking |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D001519 | Behavior |
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| Silver Wintergreen | Other | Comparator product containing 6 mg silver salt and no tobacco (i.e., no nicotine), administered orally as a single dose. |
|