NCT01595620已完成早期 1 期
Cannabinoid Modulation of Pain
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
- Capsaicin-induced hyperalgesia
研究概览
简要总结
The purpose of this study is to test the effects of cannabinoids on pain response using a variety of human experimental pain models.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Health Services Research
- 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 lifetime exposure to cannabis
- •Acceptable Birth Control methods for females
排除标准
- •Cannabis naive
- •Medical or psychiatric contraindications
- •Analgesic medication
- •Previous sensitivity to THC or cannabis
研究组 & 干预措施
THC 0.01 mg/kg
Active Comparator
干预措施: Thermal (Other)
THC 0.01 mg/kg
Active Comparator
干预措施: Electrical (Other)
THC 0.01 mg/kg
Active Comparator
干预措施: Capsaicin (Other)
THC 0.01 mg/kg
Active Comparator
干预措施: THC (Drug)
Placebo
Placebo Comparator
干预措施: Thermal (Other)
Placebo
Placebo Comparator
干预措施: Electrical (Other)
Placebo
Placebo Comparator
干预措施: Capsaicin (Other)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
THC 0.03 mg/kg
Active Comparator
干预措施: Thermal (Other)
THC 0.03 mg/kg
Active Comparator
干预措施: Electrical (Other)
THC 0.03 mg/kg
Active Comparator
干预措施: Capsaicin (Other)
THC 0.03 mg/kg
Active Comparator
干预措施: THC (Drug)
结局指标
主要结局
Capsaicin-induced hyperalgesia
时间窗: On each test day at baseline (-30), peak (+20) and post (+120) drug administration
次要结局
- Pain Measures(On each test day at baseline (-30), peak (+20) and post (+120) drug administration)
- Non-pain subjective responses(On each test day at baseline (-30), peak (+20) and post (+120) drug administration)
- Cognitive subjective responses(On each test day at baseline (-30), peak (+20) and post (+120) drug administration)
研究者
研究点 (1)
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