Varenicline Effects In Schizophrenic Smokers

NCT ID: NCT00548470

Last Updated: 2018-09-20

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2010-12-31

Brief Summary

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This is an open label pre-post study of the effects of clinical treatment with varenicline on 1) decreasing smoking in schizophrenic patients, 2) improving selected cognitive measures in schizophrenic patients, and 3) psychopathology in schizophrenic patients. Patients are assessed on subjective and objective measures of smoking, selected cognitive measures, and special chemical measures, during baseline testing and during 8 weeks of treatment with varenicline (1-2 mg/day).

Detailed Description

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Conditions

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Schizophrenia Tobacco Use Disorder Nicotine Dependance

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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varenicline

open label varenicline 2mg/day

Group Type EXPERIMENTAL

Varenicline

Intervention Type DRUG

Varenicline 1-2 mg/day

Interventions

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Varenicline

Varenicline 1-2 mg/day

Intervention Type DRUG

Other Intervention Names

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Chantix

Eligibility Criteria

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Inclusion Criteria

* Clinical Diagnosis of Schizophrenia or Schizoaffective Psychosis
* Recent History of Cigarette smoking
* Ages 18-65
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Illinois at Chicago

OTHER

Sponsor Role collaborator

Nathan Kline Institute for Psychiatric Research

OTHER

Sponsor Role lead

Responsible Party

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Robert C. Smith MD PhD

Research Psychiatrist, Prinicipal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Robert C Smith, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Nathan Kline Institute of Psychiatric Research; NYU School of Medicine

Locations

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Manhattan Psychiatric Center

New York, New York, United States

Site Status

Countries

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United States

References

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Smith RC, Lindenmayer JP, Davis JM, Cornwell J, Noth K, Gupta S, Sershen H, Lajtha A. Cognitive and antismoking effects of varenicline in patients with schizophrenia or schizoaffective disorder. Schizophr Res. 2009 May;110(1-3):149-55. doi: 10.1016/j.schres.2009.02.001. Epub 2009 Feb 28.

Reference Type RESULT
PMID: 19251401 (View on PubMed)

Other Identifiers

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06I/C34-0

Identifier Type: -

Identifier Source: org_study_id

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