Ignite Creation Date:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2025-12-28 @ 10:33 PM
Study NCT ID:
NCT00702793
Status:
WITHDRAWN
Last Update Posted:
2017-11-29
First Post:
2008-06-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Tolerability of Varenicline in Schizophrenia (SATOVA)
Sponsor:
University of British Columbia
Organization:
Study Overview
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
Status:
WITHDRAWN
Status Verified Date:
2017-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
No participants enrolled
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 affects the symptoms of schizophrenia.
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 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: