Varenicline Effects In Schizophrenic Smokers

Phase 4

Completed

• Conditions: Schizophrenia; Tobacco Use Disorder; Nicotine Dependance
• Interventions: Drug: Varenicline

• Registration Number: NCT00548470
• Lead Sponsor: Nathan Kline Institute for Psychiatric Research

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2007-06
• Study First Submitted: 2007-10-22
• Study First Submitted QC: 2007-10-23
• Study First Posted: 2007-10-24
• Primary Completion: 2009-09
• Study Completion: 2010-12
• Results First Submitted: 2016-12-17
• Results First Submitted QC: 2017-08-02
• Results First Posted: 2017-09-05
• Status Verified: 2017-10
• Last Update Submitted: 2018-08-21
• Last Update Posted: 2018-09-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
varenicline	Varenicline	open label varenicline 2mg/day

Primary Outcome Measures

Name	Time	Method
Self Report of Smoking	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	baseline and during 2 months of treatment	Carbon Monoxide in breath ,parts per million
Plasma Cotinine	baseline 1 month and 2 months	cotinine level in plasma ng/ml.

Secondary Outcome Measures

Name	Time	Method
RBANS Neuropsychological Battery	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. 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	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.

Trial Locations

Locations (1)

Manhattan Psychiatric Center; 🇺🇸 New York, New York, United States