Varenicline Effects In Schizophrenic Smokers

This study is currently recruiting participants.

Verified by Manhattan Psychiatric Center, October 2007

First Received: October 22, 2007 Last Updated: October 23, 2007 History of Changes

Sponsors and Collaborators:	Manhattan Psychiatric Center University of Illinois
Information provided by:	Manhattan Psychiatric Center
ClinicalTrials.gov Identifier:	NCT00548470

Purpose

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) effects nicotinic binding to leukocytes and DNMT1 mRNA in lymphocytes. 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 ( 1-3 mg/day).

Condition	Intervention	Phase
Schizophrenia Tobocco Use Disorder Nicotine Dependance	Drug: Varenicline	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	Evaluation of Varenicline's Clinical Efficacy for Continued Smoking Abstinence When Used in the Clinical Treatment of Schizophrenic Patients Hospitalized in an Institution With a Ban on Cigarette Smoking

Resource links provided by NLM:

MedlinePlus related topics: Schizophrenia Smoking

Drug Information available for: Varenicline

U.S. FDA Resources

Further study details as provided by Manhattan Psychiatric Center:

Primary Outcome Measures:

self report of smoking [ Time Frame: baseline and during 8 weeks of treatment ]
CO breathalyzer level [ Time Frame: baseline and during 8 weeks of treatment ]
plasma nicotine and cotinine [ Time Frame: base and 8 weeks of treatment ]

Secondary Outcome Measures:

RBANS neuropsychological battery [ Time Frame: baseline and 8 weeks of treatment ]
Human Analogue of computer water maze task [ Time Frame: baseline and 8 weeks of treatment ]

Estimated Enrollment:	20
Study Start Date:	June 2007
Estimated Study Completion Date:	December 2009

Intervention Details:

Varenicline 1-3 mg/day

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Clinical Diagnosis of Schizophrenia or Schizoaffective Psychosis
Recent History of Cigarette smoking
Ages 18-65

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00548470

Locations

United States, New York
Manhattan Psychatirc Center	Recruiting
New York City, New York, United States, 10035
Contact: James Cornwell, BA 646-672-6964 marcjfc@omh.state.ny.us
Principal Investigator: Robert C Smith, MDm PhD

Sponsors and Collaborators

Manhattan Psychiatric Center

University of Illinois

Investigators

Principal Investigator:

Robert C Smith, MD, PhD

Manhattan Psychiatric Center; NYU School of Medicine

More Information

No publications provided

Study ID Numbers:	06I/C34-0
Study First Received:	October 22, 2007
Last Updated:	October 23, 2007
ClinicalTrials.gov Identifier:	NCT00548470 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Manhattan Psychiatric Center:

schizophrenia
varenicline
cognition
cigarette smoking

Study placed in the following topic categories:

Schizophrenia
Smoking
Mental Disorders
Tobacco Use Disorder
Substance-Related Disorders

Disorders of Environmental Origin
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features
Varenicline

Additional relevant MeSH terms:

Schizophrenia
Mental Disorders
Tobacco Use Disorder

Substance-Related Disorders
Disorders of Environmental Origin
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on September 10, 2009