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

• ClinicalTrials.gov Identifier: NCT00141206
• Recruitment Status: Completed
• First Posted: September 1, 2005
• Last Update Posted: June 4, 2007
• Sponsor: Pfizer
• Information provided by: Pfizer

Tracking Information

• First Submitted Date: August 30, 2005
• First Posted Date: September 1, 2005
• Last Update Posted Date: June 4, 2007
• Study Start Date: May 2003
• Primary Completion Date: Not Provided
• Current Primary Outcome Measures (submitted: June 1, 2007): 4 week Continuous Quit Rate ( 4 week CQR ) for weeks 9 -12
• Original Primary Outcome Measures (submitted: August 30, 2005): 4 week continuous quit rate ( 4 week CQR ) for weeks 9 -12

Current Secondary Outcome Measures (submitted: June 1, 2007)

• Continuous abstinence Weeks 9-52
• Long-term Quit Rate Week 52
• Continuous abstinence Weeks 9 -24
• 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

• Original Secondary Outcome Measures (submitted: August 30, 2005): Continuous abstinence rate weeks 9-52 Long-term quit rate week 52 Continuous abstinence 9 -24 7 day point prevalence week 12, 24, and 52 Results of Minnesota Nicotine Withdrawal Scale Brief Questionnaire of Smoking Urges Smoking Effects Inventory
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Twelve-Week Study of Varenicline for Safety and Efficacy in Comparison With Placebo and Zyban for Smoking Cessation
• Official Title: A Twelve-Week, Double-Blind, Placebo-Controlled, Randomized, Multicenter Study With Follow-up Evaluating the Safety and Efficacy of Varenicline Tartrate ( CP-526,555) in Comparison to Zyban for Smoking Cessation
• Brief 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double; Primary Purpose: Treatment
• Condition: Smoking Cessation
• Intervention: Drug: varenicline (CP-526,555)
• Study Arms: Not Provided

Publications *

• 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.
• Gonzales D, Rennard SI, Nides M, Oncken C, Azoulay S, Billing CB, Watsky EJ, Gong J, Williams KE, Reeves KR; Varenicline Phase 3 Study Group. Varenicline, an alpha4beta2 nicotinic acetylcholine receptor partial agonist, vs sustained-release bupropion and placebo for smoking cessation: a randomized controlled trial. JAMA. 2006 Jul 5;296(1):47-55. doi: 10.1001/jama.296.1.47.

Recruitment Information

• Recruitment Status: Completed
• Enrollment (submitted: August 30, 2005): 1005
• Original Enrollment: Same as current
• Actual Study Completion Date: April 2005
• Primary Completion Date: Not Provided

Eligibility Criteria

Inclusion Criteria:

• Subjects must have smoked an average of at least 10 cigarettes per day during the past year and over the month prior to the screening visit, with no period of abstinence greater than 3 months in the past year.

Exclusion Criteria:

• Subjects who have used bupropion (Zyban, or Wellbutrin) previously.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00141206
• Other Study ID Numbers: A3051028
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Not Provided
• Original Responsible Party: Same as current
• Current Study Sponsor: Pfizer
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

• PRS Account: Pfizer
• Verification Date: June 2007