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Safety and Tolerability of Varenicline in Schizophrenia (SATOVA)

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ClinicalTrials.gov Identifier: NCT00702793
Recruitment Status : Withdrawn (No participants enrolled)
First Posted : June 20, 2008
Last Update Posted : November 29, 2017
Sponsor:
Collaborator:
Provincial Health Services Authority
Information provided by (Responsible Party):
Ric Procyshyn, University of British Columbia

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.

Condition or disease Intervention/treatment Phase
Schizophrenia Schizoaffective Psychosis Drug: Varenicline Phase 4

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).

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : April 2008
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Safety and tolerability, nicotine dependence, and smoking cessation/reduction. These outcomes will be measured at study visits 1-12. [ Time Frame: 12 weeks ]


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Ages Eligible for Study:   19 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Ric Procyshyn, Principle Investigator, University of British Columbia
ClinicalTrials.gov Identifier: NCT00702793     History of Changes
Other Study ID Numbers: H07-02939
First Posted: June 20, 2008    Key Record Dates
Last Update Posted: November 29, 2017
Last Verified: November 2017

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

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