Safety and Tolerability of Varenicline in Schizophrenia (SATOVA)

NCT00702793 | Withdrawn Phase 4

• 1 other identifier: H07-02939
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Schizophrenia; Schizoaffective; Psychosis

Keywords

Smoking cessation; schizophrenia; schizoaffective; psychosis; varenicline; champix; chantix; nicotine dependence

Outcome Measures

Primary Outcomes (1)

• Changes in the symptoms of the primary illness. These outcomes will be measured at study visits 1, 2, 4, 8, and 12.

  12 weeks

Secondary Outcomes (1)

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

  12 weeks

Study Arms (1)

1

EXPERIMENTAL

Smoking cessation drug - varenicline

Drug: Varenicline

Interventions

Varenicline DRUG

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.

Also known as: Champix, Chantix

1

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of British Columbia: lead
• Provincial Health Services Authority British Columbia: collaborator

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders; Smoking Cessation; Tobacco Use Disorder

Interventions

Varenicline

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Health Behavior; Behavior; Substance-Related Disorders; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinoxalines

Study Officials

• Ric M. Procyshyn, Ph.D

  University of British Columbia

  PRINCIPAL INVESTIGATOR

• 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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: June 18, 2008
• First Posted: June 20, 2008
• Study Start: April 1, 2008
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: November 29, 2017

Record last verified: 2017-11