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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 and Zyban for smoking cessation.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| varenicline (CP-526,555) | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| 4 week Continuous Quit Rate ( 4 week CQR ) for Weeks 9 -12. |
| Measure | Description | Time Frame |
|---|---|---|
| Continuous abstinence Weeks 9-52 | ||
| Long-term Quit Rate Week 52 | ||
| Continuous abstinence Weeks 9 -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 | Palo Alto | 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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| 7-day Point Prevalence Abstinence Weeks 12, 24, and 52 |
| 4-week Point Prevalence Abstinence at Week 52 |
| Minnesota Nicotine Withdrawal Scale |
| Brief Questionnaire of Smoking Urges |
| Smoking Effects Inventory |
| Change from baseline in bodyweight |
| San Diego |
| California |
| United States |
| Pfizer Investigational Site | Denver | Colorado | United States |
| Pfizer Investigational Site | Pembroke Pines | Florida | United States |
| Pfizer Investigational Site | Indianapolis | Indiana | United States |
| Pfizer Investigational Site | Portland | Maine | United States |
| Pfizer Investigational Site | Boston | Massachusetts | United States |
| Pfizer Investigational Site | Albert Lea | Minnesota | United States |
| Pfizer Investigational Site | Rochester | Minnesota | United States |
| Pfizer Investigational Site | New York | New York | United States |
| Pfizer Investigational Site | Rochester | New York | United States |
| Pfizer Investigational Site | Providence | Rhode Island | United States |
| Pfizer Investigational Site | Nashville | Tennessee | United States |
| Pfizer Investigational Site | Madison | Wisconsin | United States |
| Pfizer Investigational Site | Milwaukee | Wisconsin | United States |
| 20884658 | Derived | Hays JT, Croghan IT, Baker CL, Cappelleri JC, Bushmakin AG. Changes in health-related quality of life with smoking cessation treatment. Eur J Public Health. 2012 Apr;22(2):224-9. doi: 10.1093/eurpub/ckq137. Epub 2010 Sep 30. |
| 20819082 | Derived | Gonzales D, Jorenby DE, Brandon TH, Arteaga C, Lee TC. Immediate versus delayed quitting and rates of relapse among smokers treated successfully with varenicline, bupropion SR or placebo. Addiction. 2010 Nov;105(11):2002-13. doi: 10.1111/j.1360-0443.2010.03058.x. Epub 2010 Sep 1. |
| 20457644 | Derived | Hays JT, Leischow SJ, Lawrence D, Lee TC. Adherence to treatment for tobacco dependence: association with smoking abstinence and predictors of adherence. Nicotine Tob Res. 2010 Jun;12(6):574-81. doi: 10.1093/ntr/ntq047. Epub 2010 May 10. |
| 18442345 | Derived | Nides M, Glover ED, Reus VI, Christen AG, Make BJ, Billing CB Jr, Williams KE. Varenicline versus bupropion SR or placebo for smoking cessation: a pooled analysis. Am J Health Behav. 2008 Nov-Dec;32(6):664-75. doi: 10.5555/ajhb.2008.32.6.664. |
| 18084743 | Derived | West R, Baker CL, Cappelleri JC, Bushmakin AG. Effect of varenicline and bupropion SR on craving, nicotine withdrawal symptoms, and rewarding effects of smoking during a quit attempt. Psychopharmacology (Berl). 2008 Apr;197(3):371-7. doi: 10.1007/s00213-007-1041-3. Epub 2007 Dec 15. |
| 16820547 | Derived | Jorenby DE, Hays JT, Rigotti NA, Azoulay S, Watsky EJ, Williams KE, Billing CB, Gong J, Reeves KR; Varenicline Phase 3 Study Group. Efficacy of varenicline, an alpha4beta2 nicotinic acetylcholine receptor partial agonist, vs placebo or sustained-release bupropion for smoking cessation: a randomized controlled trial. JAMA. 2006 Jul 5;296(1):56-63. doi: 10.1001/jama.296.1.56. |
| 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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