Randomized Study Comparing the Efficacy and Safety of Varenicline Tartrate to Placebo in Smoking Cessation When Subjects Are Allowed to Set Their Own Quit Date

Phase 4

Completed

• Conditions: Smoking Cessation
• Interventions: Drug: placebo; Drug: varenicline

• Registration Number: NCT00691483
• Lead Sponsor: Pfizer

Brief Summary

The hypothesis is that varenicline will be effective (compared with placebo) for smoking cessation when subjects are allowed to set their own quit date within the first 5 weeks of treatment.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-06-03
• Study First Submitted QC: 2008-06-03
• Study First Posted: 2008-06-05
• Study Start: 2008-09
• Primary Completion: 2009-09
• Study Completion: 2009-12
• Results First Submitted: 2010-09-09
• Results First Submitted QC: 2010-09-09
• Results First Posted: 2010-09-30
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-16
• Last Update Posted: 2015-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 659

Inclusion Criteria

• Men and women
• 18 to 75 yrs old
• Motivated to stop smoking
• Smoke at least 10 cigarettes/day

Exclusion Criteria

• Active psychiatric disease
• Severe or unstable cardiovascular or pulmonary disease
• Current or recent treatment to stop smoking
• Previous use of varenicline

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	placebo	-
varenicline	varenicline	-

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With 4-week Continuous Abstinence (CA)	Week 9 through Week 12	The percentage of participants who reported complete abstinence from cigarette smoking and other nicotine use (on the Nicotine Use Inventory) and who did not have carbon monoxide (CO) \>10 parts per million (ppm) at any visits Week 9 through Week 12. A participant was considered a responder if they met the following criterion: said they had not smoked or used nicotine products 'since the last visit' and did not have CO \>10 ppm.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With 7-day Point Prevalence of Nonsmoking (Smoking Cessation)	Week 12 and Week 24	Percentage of participants with complete abstinence from cigarette smoking or other nicotine-containing (treatment phase) or tobacco (non-treatment phase) products use for the 7 days prior to Week 12 and Week 24, respectively, who did not have CO \>10 ppm at any visits. CO-confirmed in-clinic visit.
Percentage of Participants With Continuous Abstinence (CA) From Smoking Weeks 9-24	Week 9 through Week 24	Percentage of participants with CA from cigarette smoking and other nicotine-containing (treatment phase) or tobacco (non-treatment phase) products use, who did not have CO \>10 ppm at any visits Week 9 through Week 24. A participant was considered a responder if they met the following criterion: said they had not smoked or used nicotine products 'since the last visit' and did not have CO \>10 ppm.
Percentage of Participants With Long Term Quit Through Week 24	Week 9 through Week 24	Responder for the primary endpoint of CA from Week 9 through Week 12 and who had no more than 6 days of smoking during the non-treatment phase of the study. For Weeks 13, 16, 20, and 24, long term quit was determined by CO-confirmed in-clinic visit.
Percentage of Participants With 4-week Point Prevalence of Nonsmoking	Week 24	Percentage of participants with complete abstinence from cigarette smoking or use of tobacco products for the 4 weeks prior to Week 24 who did not have CO \>10 ppm at any visits.

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇬🇧 London, United Kingdom