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OpenTrials
Completed

NCT Number: NCT00143364

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

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.

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Key information

Conditions

Smoking Cessation Behavior Health Behavior

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Pfizer Investigational Site, Palo Alto, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

varenicline (CP-526,555)

Drug

Primary outcomes

  1. 4 week Continuous Quit Rate ( 4 week CQR ) for Weeks 9 -12.

Secondary outcomes

  1. Continuous abstinence Weeks 9-52

  2. Long-term Quit Rate Week 52

  3. Continuous abstinence Weeks 9 -24

  4. 7-day Point Prevalence Abstinence Weeks 12, 24, and 52

  5. 4-week Point Prevalence Abstinence at Week 52

  6. Minnesota Nicotine Withdrawal Scale

  7. Brief Questionnaire of Smoking Urges

  8. Smoking Effects Inventory

  9. Change from baseline in bodyweight

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2003
Study completion
2005
First posted
Sep 2, 2005
Registry last updated
Jun 4, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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