A Multi-National Study To Assess How Effective And Safe The Smoking Cessation Medicine Varenicline Is In Smokers Who Have Already Tried Varenicline In The Past As A Prescription Medicine From Their Usual Healthcare Provider

• Status: Completed
• Trial end date: 2012-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The main purpose of this study is to compare the effectiveness and safety of the re-treatment of smokers with varenicline with placebo for smoking cessation during the last 4 weeks of a 12 week course of treatment. The study will also assess whether smokers remain abstinent at Week 24 (12 weeks after the end of treatment) and Week 52 (40 weeks after the end of treatment).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Treatments: Varenicline

Criteria

Inclusion Criteria:

• Smokers aged 18 years or above and wanting to stop smoking

• Smokers who have smoked an average of at least 10 cigarettes per day over the last 4 weeks

• Smokers who have tried before to stop smoking at least once with varenicline, and who took varenicline for at least 2 weeks

• The last attempt to stop smoking must be at least 3 months before entering the study

Exclusion Criteria:

• Individuals who have not tolerated varenicline well previously, or who have a current or prior medical or psychiatric history that would make entry into the trial inadvisable

• Individuals who have previously participated in clinical trials of varenicline

• Individuals who have been participating in another smoking cessation trial within the last 3 months, or other drug trial within the last 30 days