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The purpose of this study is to assess the safety and efficacy of AFQ056 and nicotine compared to placebo on craving and withdrawal symptoms during voluntary smoking stoppage in healthy smokers. This study will also assess how the body interacts with AFQ056.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AFQ065 | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction of craving by self-report questionnaires during 3 days of voluntary smoking stoppage |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in symptoms of withdrawal during 3 days of voluntary smoking stoppage | ||
| Reduction in nicotine consumption during 6 days of free smoking | ||
| Reduction in impulsivity during 3 days of free smoking and during 3 days of voluntary smoking stoppage |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Novartis | Investigator site | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Nuremberg | Germany |
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| ID | Term |
|---|---|
| D012907 | Smoking |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| Reduction in craving during 6 days of free smoking |
| Safety and tolerability of AFQ056 during treatment periods |
| Assessment of how the body interacts with AFQ056 |