Smoking Cessation Study for Patients With Schizophrenia or Schizoaffective Disorder
NCT ID: NCT00644969
Last Updated: 2011-04-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
128 participants
INTERVENTIONAL
2008-05-31
2010-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DOUBLE
Study Groups
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Placebo Arm
Randomization 2:1 treatment to placebo
placebo
Randomization 2:1 treatment to placebo
Treatment Arm
varenicline (CP-526,555)
One week of titration up to 1mg bid and 11 weeks of dosing at 1mg bid
Interventions
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placebo
Randomization 2:1 treatment to placebo
varenicline (CP-526,555)
One week of titration up to 1mg bid and 11 weeks of dosing at 1mg bid
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Current cigarette smokers (at least 15/day during the past year with no period of abstinence greater than 3 months in the past year) male or female, between the ages of 18 and 75 inclusive, who are motivated to stop smoking.
* Score 7 or higher on the Contemplation Ladder at the Screening, Week -1, and Baseline Visits.
Exclusion Criteria
* Subjects hospitalized within the past six months due to suicidal ideation or suicidal behavior or subjects considered to have serious suicidal ideation or suicidal behavior within the past six moth.
* Subjects having active suicidal ideation or behavior identified at Screen, Week -1, or Baseline Visit.
* Subjects taking Bupropion.
18 Years
75 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Pfizer, Inc.
Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Investigational Site
Aurora, Colorado, United States
Pfizer Investigational Site
Farmington, Connecticut, United States
Pfizer Investigational Site
New Haven, Connecticut, United States
Pfizer Investigational Site
Worcester, Massachusetts, United States
Pfizer Investigational Site
New Brunswick, New Jersey, United States
Pfizer Investigational Site
Durham, North Carolina, United States
Pfizer Investigational Site
Cincinnati, Ohio, United States
Pfizer Investigational Site
Pittsburgh, Pennsylvania, United States
Pfizer Investigational Site
Houston, Texas, United States
Pfizer Investigational Site
Edmonton, Alberta, Canada
Pfizer Investigational Site
Mississauga, Ontario, Canada
Pfizer Investigational Site
Toronto, Ontario, Canada
Pfizer Investigational Site
Toronto, Ontario, Canada
Pfizer Investigational Site
Toronto, Ontario, Canada
Countries
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References
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Livingstone-Banks J, Fanshawe TR, Thomas KH, Theodoulou A, Hajizadeh A, Hartman L, Lindson N. Nicotine receptor partial agonists for smoking cessation. Cochrane Database Syst Rev. 2023 May 5;5(5):CD006103. doi: 10.1002/14651858.CD006103.pub8.
Williams JM, Anthenelli RM, Morris CD, Treadow J, Thompson JR, Yunis C, George TP. A randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of varenicline for smoking cessation in patients with schizophrenia or schizoaffective disorder. J Clin Psychiatry. 2012 May;73(5):654-60. doi: 10.4088/JCP.11m07522.
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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A3051072
Identifier Type: -
Identifier Source: org_study_id
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