Clinical trial NCT00702793: Safety and Tolerability of Varenicline in Schizophrenia (SATOVA)
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 type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Schizophrenia
Schizoaffective
Psychosis
Keywords: Smoking cessation
schizophrenia
schizoaffective
psychosis
varenicline
champix
chantix
nicotine dependence
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Provincial Health Services Authority
First posted: 2008-06-20
Enrollment: 0
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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 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

Primary outcomes:
measure: Changes in the symptoms of the primary illness. These outcomes will be measured at study visits 1, 2, 4, 8, and 12.
timeFrame: 12 weeks
Secondary outcomes:
measure: Safety and tolerability, nicotine dependence, and smoking cessation/reduction. These outcomes will be measured at study visits 1-12.
timeFrame: 12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: University of British Columbia
name: Ric M. Procyshyn, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: University of British Columbia
name: Alasdair Barr, Ph.D
role: STUDY_DIRECTOR
affiliation: Forensic Psychiatric Institute
name: Joyce Coutts, MD
role: STUDY_DIRECTOR
affiliation: University of British Columbia
name: Sean Flynn, MD
role: STUDY_DIRECTOR
affiliation: Riverview Hospital
name: Chris Schenk, MD
role: STUDY_DIRECTOR
affiliation: University of British Columbia
name: William Honer, MD
role: STUDY_DIRECTOR
References: