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The purpose of the study is to measure the safety and efficacy of three doses of varenicline for smoking cessation.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CP-526,555 (varenicline) | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| The primary efficacy outcome is smoking abstinence for any continuous 4-week period (4-week CQR) during the study treatment phase. |
| Measure | Description | Time Frame |
|---|---|---|
| Fixed window 4-week CQR, Weeks 3-6, 4-7 | ||
| Continuous abstinence from Target Quit Date to Weeks 12, 24, and 52 | ||
| 7-day Point Prevalence of abstinence Week 52 |
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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 | Los Angeles | California | United States | |||
| Pfizer Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37230961 | Derived | Hajizadeh A, Howes S, Theodoulou A, Klemperer E, Hartmann-Boyce J, Livingstone-Banks J, Lindson N. Antidepressants for smoking cessation. Cochrane Database Syst Rev. 2023 May 24;5(5):CD000031. doi: 10.1002/14651858.CD000031.pub6. | |
| 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. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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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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| Number of cigarettes smoked per day |
| Minnesota Nicotine Withdrawal Scale |
| Smoking Effects Inventory |
| Brief Questionnaire of Smoking Urge |
| Farmington |
| Connecticut |
| United States |
| Pfizer Investigational Site | Minneapolis | Minnesota | United States |
| Pfizer Investigational Site | Omaha | Nebraska | United States |
| Pfizer Investigational Site | New York | New York | United States |
| Pfizer Investigational Site | Portland | Oregon | United States |
| Pfizer Investigational Site | Morgantown | West Virginia | United States |
| D011810 | Quinoxalines |