Smoking Cessation Study for Patients With Schizophrenia or Schizoaffective Disorder

Completed · Phase 3 · Has a placebo group

Conditions studied: Smoking Cessation

In brief

Study will determine whether patients with schizophrenia or schizoaffective disorder can be helped to quit smoking safely while using varenicline and receiving smoking cessation counseling.

Key facts

Study ID

NCT00644969

Run by

Pfizer

People needed

128

Starts

2008-05-01

Expected to finish

2010-04-01

Last updated by the study team

2011-04-15

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Have a diagnosis (using the SCID-I/P at screening visit) of schizophrenia or schizoaffective disorder and judged to be stable (without hospitalization or acute exacerbation and functioning in society) on psychiatric treatment for at least the past 6 month.
• 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.

You may not qualify if…

• PANSS score >70 at Screen or Baseline Visit.
• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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