Varenicline Effects In Schizophrenic Smokers

Schizophrenia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00548470
• Other study ID #: 06I/C34-0
• Status: Completed
• Phase: Phase 4
• Start date: June 2007
• Est. completion date: December 2010

Study information

• Verified date: October 2017
• Source: Nathan Kline Institute for Psychiatric Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: December 2010
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Clinical Diagnosis of Schizophrenia or Schizoaffective Psychosis

• Recent History of Cigarette smoking

• Ages 18-65

Related Conditions & MeSH terms

• Nicotine Dependance
• Schizophrenia
• Tobacco Use Disorder

Intervention

Drug:
• Varenicline
Varenicline 1-2 mg/day

Locations

Country	Name	City	State
United States	Manhattan Psychiatric Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Nathan Kline Institute for Psychiatric Research	University of Illinois at Chicago

Country where clinical trial is conducted

United States, 

References & Publications (1)

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.schr — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline and during 2 months of treatment
Primary	CO (Carbon Monoxide) Breathalyzer Level	Carbon Monoxide in breath ,parts per million	baseline and during 2 months of treatment
Primary	Plasma Cotinine	cotinine level in plasma ng/ml.	baseline 1 month and 2 months
Secondary	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.	baseline and month 2 of treatment
Secondary	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.	Baseline and 2 months later