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

Phase 3

Completed

• Conditions: Smoking Cessation

• Registration Number: NCT00141167
• Lead Sponsor: Pfizer

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 for smoking cessation.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-02
• Study First Submitted: 2005-08-30
• Study First Submitted QC: 2005-08-30
• Study First Posted: 2005-09-01
• Study Completion: 2006-01
• Status Verified: 2010-09
• Last Update Submitted: 2010-09-03
• Last Update Posted: 2010-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
4 week continuous quit rate ( 4 week CQR ) for weeks 9 -12

Secondary Outcome Measures

Name	Time	Method
Continuous abstinence rate weeks 9-24
Long-term Quit Rate at week 24
7 day point prevalence week 12 and 24
Results of Minnesota Nicotine Withdrawal Scale
Brief Questionnaire of Smoking Urges
Smoking Effects Inventory

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇨🇳 Taipei, Taiwan