Safety and Tolerability of Varenicline in Schizophrenia (SATOVA)

Schizophrenia Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00702793
• Other study ID #: H07-02939
• Status: Withdrawn
• Phase: Phase 4
• First received: June 18, 2008
• Last updated: November 27, 2017
• Start date: April 2008
• Est. completion date: May 2012

Study information

• Verified date: November 2017
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Mental Disorders
• Psychosis
• Psychotic Disorders
• Schizoaffective
• Schizophrenia

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of British Columbia	Provincial Health Services Authority

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in the symptoms of the primary illness. These outcomes will be measured at study visits 1, 2, 4, 8, and 12.		12 weeks
Secondary	Safety and tolerability, nicotine dependence, and smoking cessation/reduction. These outcomes will be measured at study visits 1-12.		12 weeks