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The primary purpose of this study is to evaluate the safety and efficacy of varenicline given for a twelve week treatment period in comparison with placebo for smoking cessation.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| varenicline | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| 4 week continuous quit rate ( 4 week CQR ) for weeks 9 -12 |
| Measure | Description | Time Frame |
|---|---|---|
| Continuous abstinence rate weeks 9-24 | ||
| Long-term Quit Rate at week 24 | ||
| 7 day point prevalence week 12 and 24 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Anyang-si | Gyeonggi-do | 431-070 | South Korea | ||
| Pfizer Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37142273 | Derived | Livingstone-Banks J, Fanshawe TR, Thomas KH, Theodoulou A, Hajizadeh A, Hartman L, Lindson N. Nicotine receptor partial agonists for smoking cessation. Cochrane Database Syst Rev. 2023 May 5;5(5):CD006103. doi: 10.1002/14651858.CD006103.pub8. | |
| 17692719 | Derived | Tsai ST, Cho HJ, Cheng HS, Kim CH, Hsueh KC, Billing CB Jr, Williams KE. A randomized, placebo-controlled trial of varenicline, a selective alpha4beta2 nicotinic acetylcholine receptor partial agonist, as a new therapy for smoking cessation in Asian smokers. Clin Ther. 2007 Jun;29(6):1027-39. doi: 10.1016/j.clinthera.2007.06.011. |
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| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D000068580 | Varenicline |
| ID | Term |
|---|---|
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Results of Minnesota Nicotine Withdrawal Scale |
| Brief Questionnaire of Smoking Urges |
| Smoking Effects Inventory |
| Daegu |
| 700-712 |
| South Korea |
| Pfizer Investigational Site | Seoul | 100-032 | South Korea |
| Pfizer Investigational Site | Seoul | 110-744 | South Korea |
| Pfizer Investigational Site | Seoul | 138-736 | South Korea |
| Pfizer Investigational Site | Kweishan | Taoyuan County | 333 | Taiwan |
| Pfizer Investigational Site | Hualien City | 970 | Taiwan |
| Pfizer Investigational Site | Kaohsiung City | 813 | Taiwan |
| Pfizer Investigational Site | Taichung | 40705 | Taiwan |
| Pfizer Investigational Site | Taipei | 100 | Taiwan |
| D011810 | Quinoxalines |