NCT02335060终止早期 1 期
Effect of N-acetylcysteine on the Acute Cognitive Effects of Delta-9-Tetrahydrocannabinol
适应症
干预措施
相关药物
试验速览
- 阶段
- 早期 1 期
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Positive and Negative Symptom Scale for Schizophrenia (PANSS)
研究概览
简要总结
The overall purpose of this study is to examine the effect of N-acetylcysteine (NAC) on the acute effects of Delta-9-tetrahydrocannabinol (THC). This will be tested by pretreating healthy individuals with NAC and then assessing their responses to THC.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Exposed to Cannabis at least once in lifetime
排除标准
- •Cannabis Naive
- •Individuals with a documented allergy to N-acetylcysteine
研究组 & 干预措施
Active N-acetylcysteine and Active Delta-9-THC
Experimental
干预措施: N-acetylcysteine (Drug)
Active N-acetylcysteine and Active Delta-9-THC
Experimental
干预措施: Delta-9-THC (Drug)
Placebo and Active Delta-9-THC
Placebo Comparator
干预措施: Delta-9-THC (Drug)
Placebo and Active Delta-9-THC
Placebo Comparator
干预措施: Placebo (Drug)
Active N-acetylcysteine and Placebo
Experimental
干预措施: N-acetylcysteine (Drug)
Active N-acetylcysteine and Placebo
Experimental
干预措施: Placebo (Drug)
Placebo and Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Positive and Negative Symptom Scale for Schizophrenia (PANSS)
时间窗: -60 minutes from administration of THC
Positive, negative, and general symptoms will be assessed using the positive, negative, and general symptom subscales of the PANSS
次要结局
- Clinician Administered Dissociative Symptoms Scale (CADSS)(-60min, -30min, +15min, +90min, +240min from administration of THC)
- Cognitive Test Battery(+20min from administration of THC)
- Visual Analog Scale (VAS)(-60min, -30min, +15min, +90min, +240min from administration of THC)
- Hopkins Verbal Learning Test (HVLT)(+20min from administration of THC)
- Psychotomimetic States Inventory (PSI)(-60min, -30min, +240min from administration of THC)
研究者
Mohini Ranganathan
Principal Investigator
Yale University
研究点 (1)
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