Safety and Tolerability of Varenicline in Schizophrenia (SATOVA)

This study has been withdrawn prior to enrollment.
(No participants enrolled)
Sponsor:
Collaborator:
Provincial Health Services Authority
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT00702793
First received: June 18, 2008
Last updated: May 7, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention Phase
Schizophrenia
Schizoaffective
Psychosis
Drug: Varenicline
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • Changes in the symptoms of the primary illness. These outcomes will be measured at study visits 1, 2, 4, 8, and 12. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety and tolerability, nicotine dependence, and smoking cessation/reduction. These outcomes will be measured at study visits 1-12. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: April 2008
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Smoking cessation drug - varenicline
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

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

Ages Eligible for Study:   19 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00702793

Sponsors and Collaborators
University of British Columbia
Provincial Health Services Authority
Investigators
Principal Investigator: Ric M. Procyshyn, Ph.D University of British Columbia
Study Director: Alasdair Barr, Ph.D University of British Columbia
Study Director: Joyce Coutts, MD Forensic Psychiatric Institute
Study Director: Sean Flynn, MD University of British Columbia
Study Director: Chris Schenk, MD Riverview Hospital
Study Director: William Honer, MD University of British Columbia
  More Information

No publications provided

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT00702793     History of Changes
Other Study ID Numbers: H07-02939
Study First Received: June 18, 2008
Last Updated: May 7, 2012
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
Smoking cessation
schizophrenia
schizoaffective
psychosis
varenicline
champix
chantix
nicotine dependence

Additional relevant MeSH terms:
Mental Disorders
Psychotic Disorders
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Varenicline
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 23, 2014