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Varenicline Effects In Schizophrenic Smokers

Primary Purpose

Schizophrenia, Tobacco Use Disorder, Nicotine Dependance

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Varenicline
Sponsored by
Nathan Kline Institute for Psychiatric Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring schizophrenia, varenicline, cognition, cigarette smoking

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Sites / Locations

  • Manhattan Psychiatric Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

varenicline

Arm Description

open label varenicline 2mg/day

Outcomes

Primary Outcome Measures

Self Report of Smoking
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
Carbon Monoxide in breath ,parts per million
Plasma Cotinine
cotinine level in plasma ng/ml.

Secondary Outcome Measures

RBANS Neuropsychological Battery
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. List Learning scores range from 0 to 40. Visual Spatial Construction index scores range from 0 to 30.. Higher scores on all these measures indicate better performance or better cognitive ability.
Change From Baseline in Psychiatric Symptoms
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.

Full Information

First Posted
October 22, 2007
Last Updated
August 21, 2018
Sponsor
Nathan Kline Institute for Psychiatric Research
Collaborators
University of Illinois at Chicago
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1. Study Identification

Unique Protocol Identification Number
NCT00548470
Brief Title
Varenicline Effects In Schizophrenic Smokers
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nathan Kline Institute for Psychiatric Research
Collaborators
University of Illinois at Chicago

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Tobacco Use Disorder, Nicotine Dependance
Keywords
schizophrenia, varenicline, cognition, cigarette smoking

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
varenicline
Arm Type
Experimental
Arm Description
open label varenicline 2mg/day
Intervention Type
Drug
Intervention Name(s)
Varenicline
Other Intervention Name(s)
Chantix
Intervention Description
Varenicline 1-2 mg/day
Primary Outcome Measure Information:
Title
Self Report of Smoking
Description
Patients self-report of smoking cigarettes. Patients were interviewed weekly about the number of cigarettes smoked. Number of cigarettes smoked in the past week.
Time Frame
Baseline and during 2 months of treatment
Title
CO (Carbon Monoxide) Breathalyzer Level
Description
Carbon Monoxide in breath ,parts per million
Time Frame
baseline and during 2 months of treatment
Title
Plasma Cotinine
Description
cotinine level in plasma ng/ml.
Time Frame
baseline 1 month and 2 months
Secondary Outcome Measure Information:
Title
RBANS Neuropsychological Battery
Description
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. List Learning scores range from 0 to 40. Visual Spatial Construction index scores range from 0 to 30.. Higher scores on all these measures indicate better performance or better cognitive ability.
Time Frame
baseline and month 2 of treatment
Title
Change From Baseline in Psychiatric Symptoms
Description
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.
Time Frame
Baseline and 2 months later

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Clinical Diagnosis of Schizophrenia or Schizoaffective Psychosis Recent History of Cigarette smoking Ages 18-65
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert C Smith, MD, PhD
Organizational Affiliation
Nathan Kline Institute of Psychiatric Research; NYU School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Manhattan Psychiatric Center
City
New York
State/Province
New York
ZIP/Postal Code
10035
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19251401
Citation
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.
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Varenicline Effects In Schizophrenic Smokers

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