Nicotinic Modulation of (NMDA) Receptor Antagonist Schizophrenia-like Information Processing Deficits in Humans
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- ERP recording procedures: Brain wave activity during tasks involving in processing auditory and visual stimuli with different degrees of attentional and memory demands will be recorded.
研究概览
简要总结
This study examines the interactive effects of ketamine and nicotine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18-50 years old
排除标准
- 未提供
研究组 & 干预措施
Ketamine and Nicotine
- 0.23 mg/kg of ketamine bolus IV (in the arm) over one minute followed by maintenance infusion at 0.58mg/kg/hour x 30 minutes, followed by 0.29 mg/kg/hour x 64 minutes.
- 13.5 µg/kg of nicotine IV (in the arm) given over 10 min (1.35 µg/min/kg), followed by a constant infusion of 31.02 µg/kg given over 85 min (0.365 µg/min/kg)
干预措施: Ketamine and Nicotine (Drug)
Placebo Comparator
-Placebo administration: Normal saline (sodium chloride 0.9%)over 95 minutes
干预措施: Placebo (Drug)
Ketamine and Placebo
Ketamine administration: 0.23 mg/kg bolus over one minute followed by maintenance infusion at 0.58mg/kg/hour x 30 minutes, followed by 0.29 mg/kg/hour x 64 minutes
Placebo administration: Normal saline (sodium chloride 0.9%)over 94 minutes
干预措施: Ketamine (Drug)
Nicotine and Placebo
Nicotine: 13.5 µg/kg given over 10 min (1.35 µg/min/kg)IV (in the arm), followed by a constant infusion of 31.02 µg/kg given over 85 min (0.365 µg/min/kg) Placebo: Normal saline (sodium chloride 0.9%)IV (in the arm)
干预措施: Nicotine (Drug)
结局指标
主要结局
ERP recording procedures: Brain wave activity during tasks involving in processing auditory and visual stimuli with different degrees of attentional and memory demands will be recorded.
时间窗: +65
IntegNeuro is a computerized battery that consists of an automated stimulus presentation to measure cognitive function.
时间窗: +25
Positive and Negative Syndrome Scale will be used to measure psychotic symptoms.
时间窗: -90, +10, +105, +180
次要结局
未报告次要终点
研究者
Deepak C. D'Souza
Associate Professor
Yale University