NCT00708994已完成早期 1 期
Cannabinoids, Psychosis, Neural Synchrony, and Information Processing
适应症
干预措施
相关药物
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Clinician Administered Dissociative Symptoms Scale, Positive and Negative Symptom Scale, Visual Analog Scale
研究概览
简要总结
The study examines the effects of delta-9-tetrahydrocannabinol (Δ9-THC), the principal active ingredient of cannabis, on neural synchrony. Neural synchrony is studied using electroencephalography (EEG).
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
- •Men and women aged 18 and 55 years (extremes included) on the day of the first dosing.
- •Exposed to cannabis at least once.
排除标准
- •Cannabis naïve
- •Positive pregnancy screen during screening
- •Hearing deficits
研究组 & 干预措施
THC
Active Comparator
- Very low dose (0.0015 mg/kg = 0.21 mg in a 70kg individual) THC, dissolved in alcohol. Administered intravenously over 10 minutes.
- Low dose (0.015 mg/kg = 1.05 mg in a 70kg individual) THC, dissolved in alcohol. This dose is roughly equivalent to smoking approximately 1/4th of a marijuana cigarette, or "joint". Administered intravenously over 10 minutes.
- Medium dose (0.03 mg/kg = 2.1 mg in a 70 kg individual) THC, dissolved in alcohol. This dose is roughly equivalent to smoking approximately 1/2 of a marijuana cigarette, or "joint". Administered intravenously over 10 minutes.
干预措施: THC (Drug)
Placebo
Placebo Comparator
• Control: small amount of alcohol intravenous (quarter teaspoon), with no THC over 10 minutes
干预措施: Placebo (Drug)
结局指标
主要结局
Clinician Administered Dissociative Symptoms Scale, Positive and Negative Symptom Scale, Visual Analog Scale
时间窗: Baseline, +10, +80
EEG
时间窗: +30
次要结局
未报告次要终点
研究者
Deepak C. D'Souza
Associate Professor
Yale University
研究点 (1)
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