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The purpose of the study is to examine the safety and efficacy and dose-response relationship of three doses of CP-526,555 for 12 weeks compared with placebo for smoking cessation; including post-treatment follow-up of smoking status to one year from randomization. A small satellite protocol (A3051048) investigated safety of a second course of therapy in subjects who did not quit.
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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) for Weeks 9-12 |
| Measure | Description | Time Frame |
|---|---|---|
| Continuous abstinence for Weeks 9-52 and Weeks 9-24 | ||
| Long-term quit rate at Week 52 | ||
| 4-week CQR for Weeks 4-7 |
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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 | Noda | Chiba | Japan | |||
| 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. | |
| 24811751 | Derived | Nakamura M, Oshima A, Ohkura M, Arteaga C, Suwa K. Predictors of lapse and relapse to smoking in successful quitters in a varenicline post hoc analysis in Japanese smokers. Clin Ther. 2014 Jun 1;36(6):918-27. doi: 10.1016/j.clinthera.2014.03.013. Epub 2014 May 5. |
| 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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| 7-day point prevalence of asbtinence Weeks 12, Week 24, and Week 52 |
| Continuous abstinence from TQD (Week 1) through Week 12 |
| Weekly average number of cigarettes smoked per day for Weeks 1-12 |
| Evaluation of withdrawal symptoms by the Minnesota Nicotine Withdrawal Scale |
| Evaluation of smoking satisfaction by the Smoking Effects Inventory |
| Evaluation of urge to smoke by the Brief Questionnaire of Smoking Urges |
| Fukuoka |
| Fukuoka |
| Japan |
| Pfizer Investigational Site | Sapporo | Hokkaido | Japan |
| Pfizer Investigational Site | Yokohama | Kanagawa | Japan |
| Pfizer Investigational Site | Ohita | Ohita | Japan |
| Pfizer Investigational Site | Beppu-shi | Oita Prefecture | Japan |
| Pfizer Investigational Site | Toyonaka | Osaka | Japan |
| Pfizer Investigational Site | Tosu | Saga-ken | Japan |
| Pfizer Investigational Site | Hamamatsu | Shizuoka | Japan |
| Pfizer Investigational Site | Edogawa-ku | Tokyo | Japan |
| Pfizer Investigational Site | Minato-ku | Tokyo | Japan |
| Pfizer Investigational Site | Musashino | Tokyo | Japan |
| Pfizer Investigational Site | Setagaya-ku | Tokyo | Japan |
| Pfizer Investigational Site | Shinagawa-ku | Tokyo | Japan |
| Pfizer Investigational Site | Toshima-ku | Tokyo | Japan |
| 17692720 | Derived | Nakamura M, Oshima A, Fujimoto Y, Maruyama N, Ishibashi T, Reeves KR. Efficacy and tolerability of varenicline, an alpha4beta2 nicotinic acetylcholine receptor partial agonist, in a 12-week, randomized, placebo-controlled, dose-response study with 40-week follow-up for smoking cessation in Japanese smokers. Clin Ther. 2007 Jun;29(6):1040-56. doi: 10.1016/j.clinthera.2007.06.012. |
| D011810 | Quinoxalines |