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Completed

NCT Number: NCT00139750

12 Week Evaluation of the Safety and Efficacy of 3 Doses of CP-526,555 and Placebo for Smoking Cessation

The purpose of the study is to examine the safety and efficacy and dose-response relationship of three doses of CP-526,555 for 12 weeks compared with placebo for smoking cessation; including post-treatment follow-up of smoking status to one year from randomization. A small satellite protocol (A3051048) investigated safety of a second course of therapy in subjects who did not quit.

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Key information

Conditions

Smoking Cessation Behavior Health Behavior

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Pfizer Investigational Site, Noda, Chiba, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Cigarette smokers who are motivated to stop smoking and have smoked an average of at least 10 cigarettes per day

Exclusion criteria

  • Subjects who have used a nicotine replacement product within 30 days of the study screening visit or intend to use it during the study.

Treatment and study plan

CP-526,555 (varenicline)

Drug

Primary outcomes

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

Secondary outcomes

  1. Continuous abstinence for Weeks 9-52 and Weeks 9-24

  2. Long-term quit rate at Week 52

  3. 4-week CQR for Weeks 4-7

  4. 7-day point prevalence of asbtinence Weeks 12, Week 24, and Week 52

  5. Continuous abstinence from TQD (Week 1) through Week 12

  6. Weekly average number of cigarettes smoked per day for Weeks 1-12

  7. Evaluation of withdrawal symptoms by the Minnesota Nicotine Withdrawal Scale

  8. Evaluation of smoking satisfaction by the Smoking Effects Inventory

  9. Evaluation of urge to smoke by the Brief Questionnaire of Smoking Urges

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A Double-Blind, Placebo-Controlled, Randomized, Multicenter Study Evaluating The Efficacy And Safety Of CP-526,555 In Smokers Motivated To Stop Smoking

Important dates

Study start
2004
Study completion
2006
First posted
Aug 31, 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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