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Varenicline Effects In Schizophrenic Smokers

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00548470
First Posted: October 24, 2007
Last Update Posted: November 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
University of Illinois at Chicago
Information provided by (Responsible Party):
Robert C. Smith MD PhD, Nathan Kline Institute for Psychiatric Research
  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)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).

Condition Intervention Phase
Schizophrenia Tobacco Use Disorder Nicotine Dependance Drug: Varenicline Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (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 Robert C. Smith MD PhD, Nathan Kline Institute for Psychiatric Research:

Primary Outcome Measures:
  • Self Report of Smoking [ Time Frame: Baseline and during 2 months of treatment ]
    Patients self-report of smoking cigarettes. Patients were interviewed weekly about the number of cigarettes smoked. Number of cigarettes smoked in the past week.

  • CO (Carbon Monoxide) Breathalyzer Level [ Time Frame: baseline and during 2 months of treatment ]
  • Plasma Cotinine [ Time Frame: baseline 1 month and 2 months ]
    cotinine level in plasma ng/ml.


Secondary Outcome Measures:
  • RBANS Neuropsychological Battery [ Time Frame: baseline and month 2 of treatment ]
    The scale is Repeatable Battery for the Assessment to Neuropsychological Status (RBANS). This scale measures cognitive function in patients with schizophrenia. RBANS scores for list learning range from 0 to 40. RBANS Index scores for visual-spatial index, language index, and Total score range from 40-160. RBANS Total score is the sum of score of all the individual items ( items 1-12) on the RBANS scale. Higher scores on all these measures indicate better performance or better cognitive ability.

  • Change From Baseline in Psychiatric Symptoms [ Time Frame: Baseline and 2 months later ]
    The Positive and Negative Syndrome Scale (PANSS) was used to measure psychiatric symptoms. Item scores ranged from 1 (Absent) to 6 (Severe) for symptoms on the Positive Scale (total subscale range: 7-42), the Negative Scale (total subscale range: 7-42), and the General Psychopathology Scale (total subscale range:16-96). All three subscales were summed for the PANSS total score (total scale range: 30-180). Higher numbers indicate more psychopathology. Therefore, if scores are reduced at post-baseline ratings, this would indicate lower psychopathology.


Enrollment: 14
Study Start Date: June 2007
Study Completion Date: December 2010
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: vareniciline
open label varenicline 2mg/day
Drug: Varenicline
Varenicline 1-2 mg/day
Other Name: Chantix

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00548470


Locations
United States, New York
Manhattan Psychatirc Center
New York, 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
First Submitted: October 22, 2007
First Posted: October 24, 2007
Results First Submitted: December 17, 2016
Results First Posted: September 4, 2017
Last Update Posted: November 14, 2017
Last Verified: October 2017

Keywords provided by Robert C. Smith MD PhD, Nathan Kline Institute for Psychiatric Research:
schizophrenia
varenicline
cognition
cigarette smoking

Additional relevant MeSH terms:
Schizophrenia
Tobacco Use Disorder
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Varenicline
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs