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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-004387-38 | EudraCT Number |
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The purpose of this study is to evaluate the reduction of craving and its time course after administration of V0018 2.5 mg compared to placebo in healthy highly dependant smokers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1 | Experimental | Treatment group sequence: Test Product on Day 1 and Placebo on Day 2 |
|
| Sequence 2 | Experimental | Treatment group sequence: Placebo on Day 1 and Test Product on Day 2 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| V0018 | Drug | Oromucosal - Single dose |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Questionnaire for Smoking Urges Brief (QSU-Brief) (10 items) | Change from study baseline to 15 minutes after treatment intake for the QSU-brief total score and demonstrate any earlier effect. | 15 minutes |
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Inclusion Criteria:
Exclusion Criteria:
Related to pathologies
Related to treatments
For women of childbearing potential:
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| Name | Affiliation | Role |
|---|---|---|
| Françoise MD TONNER | Pierre Fabre Medicament | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gières | France |
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| Placebo |
| Drug |
Oromucosal - Single dose |
|