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The purpose of the study was to measure the safety and efficacy of a 12-week flexible dosing strategy of CP-526,555 compared with placebo for smoking cessation. Post-treatment follow-up of smoking status to one year from randomization was performed in a non-treatment extension Protocol A3051019
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CP-526,555 (varenicline) | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| 4-week continuous quit rate (CQR) at Weeks 4-7 and 9-12 . |
| Measure | Description | Time Frame |
|---|---|---|
| Continuous abstinence rate from target quit date to end of treatment (Week 12) | ||
| 7-day point prevalence of abstinence at Week 12 | ||
| Number of cigarettes smoked per day |
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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 | Lexington | Kentucky | United States | |||
| 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. | |
| 18513462 | Derived | Niaura R, Hays JT, Jorenby DE, Leone FT, Pappas JE, Reeves KR, Williams KE, Billing CB Jr. The efficacy and safety of varenicline for smoking cessation using a flexible dosing strategy in adult smokers: a randomized controlled trial. Curr Med Res Opin. 2008 Jul;24(7):1931-41. doi: 10.1185/03007990802177523. Epub 2008 May 29. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| Urge to smoke and withdrawal symptoms assessed by Minnesota Nicotine Withdrawal Scale |
| Rewarding effects of smoking assessed by Smoking Effects Inventory |
| weight change from baseline |
| Albert Lea |
| Minnesota |
| United States |
| Pfizer Investigational Site | Rochester | Minnesota | United States |
| Pfizer Investigational Site | Philadelphia | Pennsylvania | United States |
| Pfizer Investigational Site | Providence | Rhode Island | United States |
| Pfizer Investigational Site | La Crosse | Wisconsin | United States |
| Pfizer Investigational Site | Madison | Wisconsin | United States |
| 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 |
| D011810 | Quinoxalines |
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