Safety and Tolerability of Varenicline in Schizophrenia (SATOVA)

• Status: Withdrawn
• Trial end date: 2012-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of British Columbia
• Collaborator: Provincial Health Services Authority
• Treatments: Varenicline

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