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Trial record 6 of 8 for:    smoking cessation | ( Map: Mexico )

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

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ClinicalTrials.gov Identifier: NCT00691483
Recruitment Status : Completed
First Posted : June 5, 2008
Results First Posted : September 30, 2010
Last Update Posted : November 20, 2015
Sponsor:
Information provided by:
Pfizer

Brief Summary:
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 or disease Intervention/treatment Phase
Smoking Cessation Drug: placebo Drug: varenicline Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 659 participants
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
Study Start Date : September 2008
Actual Primary Completion Date : September 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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 :
  1. 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.

  2. 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.

  3. 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.

  4. 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:
  1. 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
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

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


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Locations
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United States, Arizona
Pfizer Investigational Site
Litchfield Park, Arizona, United States, 85340
United States, California
Pfizer Investigational Site
Los Angeles, California, United States, 90095
Pfizer Investigational Site
Santa Ana, California, United States, 92705
United States, Kansas
Pfizer Investigational Site
Overland Park, Kansas, United States, 66212
United States, Kentucky
Pfizer Investigational Site
Lexington, Kentucky, United States, 40509
United States, Massachusetts
Pfizer Investigational Site
Milford, Massachusetts, United States, 01757
United States, Nebraska
Pfizer Investigational Site
Omaha, Nebraska, United States, 68116-2004
United States, New York
Pfizer Investigational Site
Endwell, New York, United States, 13760
United States, Pennsylvania
Pfizer Investigational Site
Bridgeville, Pennsylvania, United States, 15017
Pfizer Investigational Site
Philadelphia, Pennsylvania, United States, 19146
United States, Tennessee
Pfizer Investigational Site
Nashville, Tennessee, United States, 37203
United States, Texas
Pfizer Investigational Site
Houston, Texas, United States, 77030
Argentina
Pfizer Investigational Site
Buenos Aires, Argentina, C1405BCH
Brazil
Pfizer Investigational Site
Santo André, SP, Brazil, 09060-650
Canada, Alberta
Pfizer Investigational Site
Calgary, Alberta, Canada, T1Y 6J4
Canada
Pfizer Investigational Site
Quebec, Canada, G1V 4M6
China, Liaoning
Pfizer Investigational Site
Shenyang, Liaoning, China, 110016
China
Pfizer Investigational Site
Beijing, China, 100020
Pfizer Investigational Site
Guangzhou, China, 510120
Czech Republic
Pfizer Investigational Site
Brno, Czech Republic, 656 91
Pfizer Investigational Site
Praha 2, Czech Republic, 120 00
France
Pfizer Investigational Site
Caen, France, 14033
Germany
Pfizer Investigational Site
Berlin, Germany, 10787
Pfizer Investigational Site
Goettingen, Germany, 37075
Hungary
Pfizer Investigational Site
Budapest, Hungary, 1525
Pfizer Investigational Site
Debrecen, Hungary, 4012
Italy
Pfizer Investigational Site
Pisa, Italy, 56124
Korea, Republic of
Pfizer Investigational Site
Seoul, Korea, Republic of, 110-744
Pfizer Investigational Site
Seoul, Korea, Republic of, 135-710
Mexico
Pfizer Investigational Site
Monterrey, Nuevo Leon, Mexico, 64460
Taiwan
Pfizer Investigational Site
Gwei Shan Township, Taoyuan County, Taiwan, 333
Pfizer Investigational Site
Kaohsiung, Taiwan, 813
United Kingdom
Pfizer Investigational Site
London, United Kingdom, SW18 4DD
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00691483     History of Changes
Other Study ID Numbers: A3051095
First Posted: June 5, 2008    Key Record Dates
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:
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Varenicline
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs