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Randomized Study Comparing the Efficacy and Safety of Varenicline Tartrate to Placebo in Smoking Cessation When Subjects Are Allowed to Set Their Own Quit Date

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00691483
First Posted: June 5, 2008
Last Update Posted: November 20, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Pfizer
  Purpose
The hypothesis is that varenicline will be effective (compared with placebo) for smoking cessation when subjects are allowed to set their own quit date within the first 5 weeks of treatment.

Condition Intervention Phase
Smoking Cessation Drug: placebo Drug: varenicline Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 4, Prospective, Multi-National, Randomized, Double-Blind, Placebo-Controlled Study To Evaluate Smoking Cessation With Varenicline Tartrate Compared With Placebo In The Setting Of Patient Self-Selected (Flexible) Quit Date

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Percentage of Participants With 4-week Continuous Abstinence (CA) [ Time Frame: Week 9 through Week 12 ]
    The percentage of participants who reported complete abstinence from cigarette smoking and other nicotine use (on the Nicotine Use Inventory) and who did not have carbon monoxide (CO) >10 parts per million (ppm) at any visits Week 9 through Week 12. A participant was considered a responder if they met the following criterion: said they had not smoked or used nicotine products 'since the last visit' and did not have CO >10 ppm.


Secondary Outcome Measures:
  • Percentage of Participants With Continuous Abstinence (CA) From Smoking Weeks 9-24 [ Time Frame: Week 9 through Week 24 ]
    Percentage of participants with CA from cigarette smoking and other nicotine-containing (treatment phase) or tobacco (non-treatment phase) products use, who did not have CO >10 ppm at any visits Week 9 through Week 24. A participant was considered a responder if they met the following criterion: said they had not smoked or used nicotine products 'since the last visit' and did not have CO >10 ppm.

  • Percentage of Participants With Long Term Quit Through Week 24 [ Time Frame: Week 9 through Week 24 ]
    Responder for the primary endpoint of CA from Week 9 through Week 12 and who had no more than 6 days of smoking during the non-treatment phase of the study. For Weeks 13, 16, 20, and 24, long term quit was determined by CO-confirmed in-clinic visit.

  • Percentage of Participants With 7-day Point Prevalence of Nonsmoking (Smoking Cessation) [ Time Frame: Week 12 and Week 24 ]
    Percentage of participants with complete abstinence from cigarette smoking or other nicotine-containing (treatment phase) or tobacco (non-treatment phase) products use for the 7 days prior to Week 12 and Week 24, respectively, who did not have CO >10 ppm at any visits. CO-confirmed in-clinic visit.

  • Percentage of Participants With 4-week Point Prevalence of Nonsmoking [ Time Frame: Week 24 ]
    Percentage of participants with complete abstinence from cigarette smoking or use of tobacco products for the 4 weeks prior to Week 24 who did not have CO >10 ppm at any visits.


Other Outcome Measures:
  • Change From Baseline in Fagerström Test for Nicotine Dependence (FTND) to Day of First Quit Attempt (FQA) Through Week 5 by Smoking Status at Weeks 9-12 [ Time Frame: Baseline through Week 5 ]
    Change in nicotine dependence from baseline to the date of the FQA within the first 5 weeks. FTND was designed to provide an ordinal measure of nicotine dependence related to cigarette smoking. It contains items that evaluate the quantity of cigarette consumption, the compulsion to use, and dependence. The FTND contains 4 yes-no and 2 multiple choice questions and can be used in a self-report format. The items on FTND are scored 0 to 3 for multiple choice items, the items are summed to yield a total score of 0-10 (0=minimum nicotine dependence; 10=maximum nicotine dependence).


Enrollment: 659
Study Start Date: September 2008
Study Completion Date: December 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: placebo Drug: placebo
placebo tablet taken orally twice daily for 12 weeks
Experimental: varenicline Drug: varenicline
varenicline tablets, 1 mg taken orally twice daily for 12 weeks
Other Name: Chantix, Champix

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men and women
  • 18 to 75 yrs old
  • Motivated to stop smoking
  • Smoke at least 10 cigarettes/day

Exclusion Criteria:

  • Active psychiatric disease
  • Severe or unstable cardiovascular or pulmonary disease
  • Current or recent treatment to stop smoking
  • Previous use of varenicline
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00691483


  Show 33 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00691483     History of Changes
Other Study ID Numbers: A3051095
First Submitted: June 3, 2008
First Posted: June 5, 2008
Results First Submitted: September 9, 2010
Results First Posted: September 30, 2010
Last Update Posted: November 20, 2015
Last Verified: October 2015

Keywords provided by Pfizer:
smoking cessation
smoking treatment
patient self-selected quit date

Additional relevant MeSH terms:
Varenicline
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs