Status:
COMPLETED
Smoking Cessation Study for Patients With Schizophrenia or Schizoaffective Disorder
Lead Sponsor:
Pfizer
Conditions:
Smoking Cessation
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
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.
Detailed Description
This is a safety study.
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
128 Patients enrolled
Trial Details
Trial ID
NCT00644969
Start Date
May 1 2008
End Date
April 1 2010
Last Update
April 15 2011
Active Locations (14)
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1
Pfizer Investigational Site
Aurora, Colorado, United States, 80045
2
Pfizer Investigational Site
Farmington, Connecticut, United States, 06030
3
Pfizer Investigational Site
New Haven, Connecticut, United States, 06519
4
Pfizer Investigational Site
Worcester, Massachusetts, United States, 01655