Status:
WITHDRAWN
Safety and Tolerability of Varenicline in Schizophrenia (SATOVA)
Lead Sponsor:
University of British Columbia
Collaborating Sponsors:
Provincial Health Services Authority British Columbia
Conditions:
Schizophrenia
Schizoaffective
Eligibility:
All Genders
19-65 years
Phase:
PHASE4
Brief Summary
This is a 15 week trial to determine (1) the safety and tolerability of varenicline when used for smoking cessation/reduction in individuals with schizophrenia; (2) if treatment with varenicline affec...
Detailed Description
Researchers are looking to recruit a total of 50 subjects at Riverview and Forensic Psychiatric Hospitals who would like to reduce or quit smoking cigarettes. This open label pilot study will gather i...
Eligibility Criteria
Inclusion
- Inpatients with a diagnosis of schizophrenia or schizoaffective disorder
- Individuals between the ages of 19 and 65 years of age
- Individuals that had smoked 10 cigarette/day or more during the previous year, and had no period of smoking abstinence longer than 3 months in the past year
- Individuals that are not expected to be discharged from hospital within 4 months.
Exclusion
- Clinically significant allergic reactions to the study medication
- Clinically significant abnormalities in the screening laboratory values
- Subjects at significant risk of self-harm
- Previous treatment with varenicline
- Women who are pregnant, breast-feeding, or of child-bearing potential not using adequate contraception
- Men not using adequate contraception
- Use of medications that might interfere with the study medication evaluation
- Nicotine replacement
- Nortriptyline
- Clonidine
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00702793
Start Date
April 1 2008
End Date
May 1 2012
Last Update
November 29 2017
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