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Completed

NCT Number: NCT00141167

A Twelve-Week Study of Varenicline for Safety and Efficacy in Comparison With Placebo 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 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, Anyang-si, Gyeonggi-do, South Korea

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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

Drug

Primary outcomes

  1. 4 week continuous quit rate ( 4 week CQR ) for weeks 9 -12

Secondary outcomes

  1. Continuous abstinence rate weeks 9-24

  2. Long-term Quit Rate at week 24

  3. 7 day point prevalence week 12 and 24

  4. Results of Minnesota Nicotine Withdrawal Scale

  5. Brief Questionnaire of Smoking Urges

  6. Smoking Effects Inventory

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A Twelve-Week, Double-Blind, Placebo-Controlled, Multicenter Study With Follow-up Evaluating the Safety and Efficacy of Varenicline Tartrate 1 MG BID for Smoking Cessation

Important dates

Study start
2005
Study completion
2006
First posted
Sep 1, 2005
Registry last updated
Sep 6, 2010

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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