A Twelve-Week Study of Varenicline for Safety and Efficacy in Comparison With Placebo and Zyban for Smoking Cessation

Summary

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.

Timeline

Start

2003-06

Primary completion

—

Completion

2005-03

Outcome

Met primary endpoint

paper 43.9% of participants in the varenicline group were continuously abstinent from smoking compared with 17.6% in the placebo group PMID 16820547 ↗

paper odds ratio [OR], 3.85; 95% confidence interval [CI], 2.69-5.50; P<.001 PMID 16820547 ↗

Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Varenicline	Small molecule	—	—

Indications

No indication recorded.