Varenicline Effects In Schizophrenic Smokers

This study has been completed.
Sponsor:
Collaborator:
University of Illinois at Chicago
Information provided by (Responsible Party):
Robert C. Smith MD PhD, Nathan Kline Institute for Psychiatric Research
ClinicalTrials.gov Identifier:
NCT00548470
First received: October 22, 2007
Last updated: May 17, 2012
Last verified: May 2012
  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 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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:


Further study details as provided by Nathan Kline Institute for Psychiatric Research:

Primary Outcome Measures:
  • self report of smoking [ Time Frame: baseline and during 8 weeks of treatment ] [ Designated as safety issue: No ]
  • CO breathalyzer level [ Time Frame: baseline and during 8 weeks of treatment ] [ Designated as safety issue: No ]
  • plasma nicotine and cotinine [ Time Frame: base and 8 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • RBANS neuropsychological battery [ Time Frame: baseline and 8 weeks of treatment ] [ Designated as safety issue: No ]
  • Human Analogue of computer water maze task [ Time Frame: baseline and 8 weeks of treatment ] [ Designated as safety issue: No ]

Enrollment: 18
Study Start Date: June 2007
Study Completion Date: December 2010
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Varenicline
    Varenicline 1-3 mg/day
    Other Name: Chantix
  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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00548470

Locations
United States, New York
Manhattan Psychatirc Center
New York City, New York, United States, 10035
Sponsors and Collaborators
Nathan Kline Institute for Psychiatric Research
University of Illinois at Chicago
Investigators
Principal Investigator: Robert C Smith, MD, PhD Nathan Kline insitutue fo Psychiatric Research; NYU School of Medicine
  More Information

Publications:
Responsible Party: Robert C. Smith MD PhD, Researchy Pasychiatrist, : Prinicipla Investigator, Nathan Kline Institute for Psychiatric Research
ClinicalTrials.gov Identifier: NCT00548470     History of Changes
Other Study ID Numbers: 06I/C34-0
Study First Received: October 22, 2007
Last Updated: May 17, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Nathan Kline Institute for Psychiatric Research:
schizophrenia
varenicline
cognition
cigarette smoking

Additional relevant MeSH terms:
Schizophrenia
Mental Disorders
Schizophrenia and Disorders with Psychotic Features
Varenicline
Cholinergic Agents
Cholinergic Agonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Nicotinic Agonists
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 20, 2014