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Effect of Varenicline on Cognitive Function in Cigarette Smokers With Schizophrenia

NCT01093365 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2016-08-26

No results posted yet for this study

Summary

Smokers with schizophrenia have more difficulties quitting smoking than smokers without a mental disorder. Varenicline (Champix) is a new stop smoking medication with a unique mechanism of action. It is a nicotine-like drug which is not addictive and not associated with the health risks of tobacco smoking.

Varenicline (VAR) binds to sites in the brain called nicotine receptors that play an important role in nicotine dependence. People with schizophrenia have difficulties in concentrating and remembering. Scientists believe that people with schizophrenia use smoking to remedy their cognitive problems. We will test VAR to see if it improves cognitive problems in smokers with schizophrenia in comparison to non-mentally ill smokers to determine whether people with schizophrenia get direct benefit from this nicotine-like drug. It is hypothesized that VAR (in comparison to a placebo) will reduce aspects of cognitive impairment in smokers and nonsmokers with schizophrenia.

Conditions

Interventions

DRUG

Varenicline

* 0.0 mg orally twice per day for three days (placebo) * 0.5 mg orally twice per day for three days * 1.0 mg orally twice per day for three days

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • Centre for Addiction and Mental Health

    lead OTHER

Principal Investigators

  • Tony P George, MD · Centre for Addiction and Mental Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2016-08-31
Completion
2016-08-31

Countries

  • Canada

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01093365 on ClinicalTrials.gov