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Assessment of Safety and Efficacy of Varenicline in Patients That Wish to Stop Smoking

This study has been completed.
Information provided by:
Pfizer Identifier:
First received: January 3, 2008
Last updated: July 14, 2010
Last verified: July 2010
The primary objective of this protocol is to evaluate 12 weeks of treatment of varenicline compared to placebo for smoking cessation. Abstinence from cigarette smoking and other tobacco products (e.g., pipe, cigars, chew, snuff.) use during non-treatment follow-up period will also be evaluated.

Condition Intervention Phase
Smoking Cessation
Drug: varenicline tartrate (CP-526, 555-18)
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A 12-Week, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study With Follow-Up Evaluating The Safety And Efficacy Of Varenicline Tartrate (CP-526,555-18) 1 Mg Bid For Smoking Cessation (Protocol A3051080)

Resource links provided by NLM:

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Number of Participants With 4-week Continuous Abstinence [ Time Frame: Weeks 9 through 12 ]
    The number of participants who, at each visit from Week 9 through 12 (inclusive), reported no smoking and no use of other nicotine-containing products since the last study visit (on the Nicotine Use Inventory) and who did not have carbon monoxide (CO) > 10 parts per milion (ppm) at any of these visits

Secondary Outcome Measures:
  • Number of Participants With Continuous Abstinence [ Time Frame: Weeks 9 through 24 ]
    The number of participants who, at each contact from Week 9 through the given timepoint, reported no smoking and no use of other nicotine-containing products (Treatment Phase) or tobacco products (Nontreatment Phase) since the last study contact(on the Nicotine Use Inventory) and who did not have CO > 10 ppm

  • Number of Participants With Seven-day Point Prevalence of Abstinence [ Time Frame: Week 12 and 24 ]
    Number of participants who, at the given visit or telephone contact, reported no smoking and no use of other nicotine-containing products (treatment phase) or tobacco products (non-treatment phase) in the last 7 days and who did not have CO >10 ppm on that day

Enrollment: 593
Study Start Date: April 2008
Study Completion Date: August 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: varenicline Drug: varenicline tartrate (CP-526, 555-18)
1 mg twice a day for 12 weeks, starting with a 1-week titration period.
Other Name: Chantix, Champix
Placebo Comparator: placebo Drug: Placebo
matching placebo 1 tablet twice a day for 12 weeks


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Current male or female cigarette smokers who are motivated to stop smoking.
  • Smoked an average of 10 cigarettes per day during past year and the month prior to first visit.

Exclusion Criteria:

  • Patients who have used a nicotine replacement product, bupropion, clonidine or notriptyline within the past 6 months.
  • Patients currently with depression or diagnosed with depression in past 12 months.
  • Past or present history of psychosis, panic disorder, or bipolar disorder.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00594204

  Show 41 Study Locations
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer
  More Information

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Inc Identifier: NCT00594204     History of Changes
Other Study ID Numbers: A3051080
Study First Received: January 3, 2008
Results First Received: May 27, 2010
Last Updated: July 14, 2010

Additional relevant MeSH terms:
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs processed this record on May 25, 2017