Safety and Tolerability of Varenicline in Schizophrenia (SATOVA)
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Safety and Tolerability of Varenicline When Used for Smoking Cessation/Reduction in Individuals With Severe and Persistent Mental Illness: An Open Label Pilot Trial|
- Changes in the symptoms of the primary illness. These outcomes will be measured at study visits 1, 2, 4, 8, and 12. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Safety and tolerability, nicotine dependence, and smoking cessation/reduction. These outcomes will be measured at study visits 1-12. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||April 2008|
|Study Completion Date:||May 2012|
|Primary Completion Date:||May 2012 (Final data collection date for primary outcome measure)|
Smoking cessation drug - varenicline
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. Administration of twice daily dosing should be at least 8 hours apart.
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).
|Principal Investigator:||Ric M. Procyshyn, Ph.D||University of British Columbia|
|Study Director:||Alasdair Barr, Ph.D||University of British Columbia|
|Study Director:||Joyce Coutts, MD||Forensic Psychiatric Institute|
|Study Director:||Sean Flynn, MD||University of British Columbia|
|Study Director:||Chris Schenk, MD||Riverview Hospital|
|Study Director:||William Honer, MD||University of British Columbia|