Safety and Tolerability of Varenicline in Schizophrenia (SATOVA)
Information source: University of British Columbia
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Schizophrenia; Schizoaffective; Psychosis
Intervention: Varenicline (Drug)
Phase: Phase 4
Status: Withdrawn
Sponsored by: University of British Columbia Official(s) and/or principal investigator(s): Ric M. Procyshyn, Ph.D, Principal Investigator, Affiliation: University of British Columbia Alasdair Barr, Ph.D, Study Director, Affiliation: University of British Columbia Joyce Coutts, MD, Study Director, Affiliation: Forensic Psychiatric Institute Sean Flynn, MD, Study Director, Affiliation: University of British Columbia Chris Schenk, MD, Study Director, Affiliation: Riverview Hospital William Honer, MD, Study Director, Affiliation: University of British Columbia
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 Details
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
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Changes in the symptoms of the primary illness. These outcomes will be measured at study visits 1, 2, 4, 8, and 12.
Secondary outcome: Safety and tolerability, nicotine dependence, and smoking cessation/reduction. These outcomes will be measured at study visits 1-12.
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).
Eligibility
Minimum age: 19 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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 Criteria:
- 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
Locations and Contacts
Additional Information
Starting date: April 2008
Last updated: May 7, 2012
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