search
Back to results

Safety and Tolerability of Varenicline in Schizophrenia (SATOVA)

Primary Purpose

Schizophrenia, Schizoaffective, Psychosis

Status
Withdrawn
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Varenicline
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Smoking cessation, schizophrenia, schizoaffective, psychosis, varenicline, champix, chantix, nicotine dependence

Eligibility Criteria

19 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    1

    Arm Description

    Smoking cessation drug - varenicline

    Outcomes

    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.

    Secondary Outcome Measures

    Safety and tolerability, nicotine dependence, and smoking cessation/reduction. These outcomes will be measured at study visits 1-12.

    Full Information

    First Posted
    June 18, 2008
    Last Updated
    November 27, 2017
    Sponsor
    University of British Columbia
    Collaborators
    Provincial Health Services Authority
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT00702793
    Brief Title
    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

    2. Study Status

    Record Verification Date
    November 2017
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    No participants enrolled
    Study Start Date
    April 2008 (undefined)
    Primary Completion Date
    May 2012 (Actual)
    Study Completion Date
    May 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of British Columbia
    Collaborators
    Provincial Health Services Authority

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Schizophrenia, Schizoaffective, Psychosis
    Keywords
    Smoking cessation, schizophrenia, schizoaffective, psychosis, varenicline, champix, chantix, nicotine dependence

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Description
    Smoking cessation drug - varenicline
    Intervention Type
    Drug
    Intervention Name(s)
    Varenicline
    Other Intervention Name(s)
    Champix, Chantix
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    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 Measure Information:
    Title
    Safety and tolerability, nicotine dependence, and smoking cessation/reduction. These outcomes will be measured at study visits 1-12.
    Time Frame
    12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    19 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ric M. Procyshyn, Ph.D
    Organizational Affiliation
    University of British Columbia
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Alasdair Barr, Ph.D
    Organizational Affiliation
    University of British Columbia
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Joyce Coutts, MD
    Organizational Affiliation
    Forensic Psychiatric Institute
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Sean Flynn, MD
    Organizational Affiliation
    University of British Columbia
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Chris Schenk, MD
    Organizational Affiliation
    Riverview Hospital
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    William Honer, MD
    Organizational Affiliation
    University of British Columbia
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Safety and Tolerability of Varenicline in Schizophrenia (SATOVA)

    We'll reach out to this number within 24 hrs