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
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Self Report of Smoking
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical Diagnosis of Schizophrenia or Schizoaffective Psychosis
- •Recent History of Cigarette smoking
- •Ages 18-65
排除标准
- 未提供
研究组 & 干预措施
varenicline
open label varenicline 2mg/day
干预措施: Varenicline (Drug)
结局指标
主要结局
Self Report of Smoking
时间窗: 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
时间窗: baseline and during 2 months of treatment
Carbon Monoxide in breath ,parts per million
Plasma Cotinine
时间窗: baseline 1 month and 2 months
cotinine level in plasma ng/ml.
次要结局
- RBANS Neuropsychological Battery(baseline and month 2 of treatment)
- Change From Baseline in Psychiatric Symptoms(Baseline and 2 months later)
研究者
Robert C. Smith MD PhD
Research Psychiatrist, Prinicipal Investigator
Nathan Kline Institute for Psychiatric Research