Safety and Tolerability of Varenicline in Schizophrenia (SATOVA)
Safety and Tolerability of Varenicline When Used for Smoking Cessation/Reduction in Individuals With Severe and Persistent Mental Illness: An Open Label Pilot Trial
  • Phase

    Phase 4
  • Study Type

  • Status

  • Study Participants

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.
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 Started
Apr 30
Primary Completion
May 31
Study Completion
May 31
Last Update
Nov 29

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.

  • Other names: Champix, Chantix

1 Experimental

Smoking cessation drug - varenicline


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
No Results Posted