Varenicline Effects In Schizophrenic Smokers

Nathan Kline Institute for Psychiatric Research14 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Schizophrenia Tobacco Use Disorder Nicotine Dependance

Interventions

VareniclineDRUG

Varenicline 1-2 mg/day

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Clinical Diagnosis of Schizophrenia or Schizoaffective Psychosis * Recent History of Cigarette smoking * Ages 18-65

Locations (1)

Manhattan Psychiatric Center

New York, New York, United States

Outcomes

Primary Outcomes

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.

Time frame: Baseline and during 2 months of treatment

CO (Carbon Monoxide) Breathalyzer Level

Carbon Monoxide in breath ,parts per million

Time frame: baseline and during 2 months of treatment

Plasma Cotinine

cotinine level in plasma ng/ml.

Time frame: baseline 1 month and 2 months

Secondary Outcomes

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.

Time frame: baseline and month 2 of treatment

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.

Data from ClinicalTrials.gov

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