NCT01591629已完成早期 1 期
Assessment of Cannabinoid-opiate Interactions in Humans With a Cannabis Use Disorder and Healthy Subjects
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
- 6
- 试验地点
- 1
- 主要终点
- Behavioral Measures
研究概览
简要总结
The purpose of this project is to examine the effects of mu-opiate antagonism on the rewarding and reinforcing effects of delta-9-tetrahydrocannabinol (THC), the main psychoactive ingredient of cannabis.
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
- •At least one exposure to Cannabis
排除标准
- •Cannabis Naive
研究组 & 干预措施
Placebo and Placebo
Placebo Comparator
干预措施: Placebo (Drug)
Active Naloxone and Placebo
Experimental
干预措施: Naloxone (Drug)
Active Naloxone and Placebo
Experimental
干预措施: Placebo (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 Naloxone and Active Delta-9-THC
Experimental
干预措施: Naloxone (Drug)
Active Naloxone and Active Delta-9-THC
Experimental
干预措施: Delta-9-THC (Drug)
结局指标
主要结局
Behavioral Measures
时间窗: 4 test days
Subjective effects and perceptual alterations will be assessed using the Positive and Negative Symptom Subscale (PANNS).
次要结局
- Visual analog scales(4 test days)
- Clinician Administered Dissociative States Scales (CADSS)(4 test days)
- Psychotomimetic States Inventory (PSI)(4 test days)
- Marijuana Withdrawal Scale(4 test days)
- Clinical Opiate Withdrawal Scale(4 test days)
- Marijuana Craving Scale(4 test days)
- Neuro cognitive battery(4 test days)
研究者
Deepak C. D'Souza
Associate Professor
Yale University
研究点 (1)
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