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Clinical Trial 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 affects the symptoms of schizophrenia.


Clinical Trial 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 information regarding the safety and tolerability of varenicline in subjects who have been diagnosed with schizophrenia or schizoaffective disorder. Consenting subjects will be prescribed varenicline as follows: varenicline 0.5 mg/d for days 1 to 3, 0.5 mg twice daily for days 4 to 7, then 1 mg twice daily through week 12. The research team will meet with the subject once a week for twelve weeks and the subject will be interviewed and asked to complete questionnaires about his/her psychiatric symptoms, tobacco use and nicotine dependence. The measures used include the FTND, PANSS, CGI-I, CGI-S, ESRS, UKU, BARS, WSWS, QSU-brief, mCEQ, and the OAS-M. The CGI-SS will also be completed throughout the study as well as once weekly for three weeks following the completion of the study (Post-Study follow-up visits 1-3). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT00702793
Study type Interventional
Source University of British Columbia
Contact
Status Withdrawn
Phase Phase 4
Start date April 2008
Completion date May 2012

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