Safety and Tolerability of Varenicline in Schizophrenia (SATOVA)

University of British Columbia

Status and phase

Withdrawn

Phase 4

Conditions

Psychosis

Schizophrenia

Schizoaffective

Treatments

Drug: Varenicline

Study type

Interventional

Funder types

Other

Identifiers

NCT00702793

H07-02939

Details and patient eligibility

About

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.

Full 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).

Sex

All

Ages

19 to 65 years old

Volunteers

No Healthy Volunteers

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