Effect of Cannabidiol on Microglial Activation and Central Pain-Sensitization
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Microglial activation using [11C]PBR28 PET imaging
研究概览
简要总结
This study aims to examine the effect of cannabidiol (CBD) pre-treatment on brain microglial activation in healthy human subjects. Secondarily, this study aims to examine the effect of cannabidiol (CBD) pre-treatment on central pain-sensitization in healthy human subjects.
详细描述
This study aims to examine the effect of cannabidiol (CBD), pre-treatment, as Epidiolex, on brain microglial activation in healthy human subjects using [11C]PBR28 PET imaging. Secondarily, this study aims to examine the effect of cannabidiol (CBD) pre-treatment on central pain-sensitization in healthy human subjects. Lastly, this research study will also examine the relationship between brain microglial activation and central pain sensitization with CBD pre-treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, 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- 55 years
- •No significant medical or neurological illness
- •No implanted metal devices that may pose a risk during MRI scanning
- •Within the annual permissible radiation exposure
- •Able to provide written informed consent.
排除标准
- •Current use of any medications
- •Presence of metal in the body
- •Pregnancy or lactation
研究组 & 干预措施
CBD
干预措施: [11C]PBR28 (Radiation)
CBD
干预措施: Low-dose lipopolysaccharide (Drug)
CBD
干预措施: Intradermal Capsaicin (Drug)
Placebo
干预措施: [11C]PBR28 (Radiation)
Placebo
干预措施: Low-dose lipopolysaccharide (Drug)
Placebo
干预措施: Intradermal Capsaicin (Drug)
结局指标
主要结局
Microglial activation using [11C]PBR28 PET imaging
时间窗: 10 Days
Difference in microglial activation (\[11C\]PBR28 VT levels) between the 2 groups (e.g., CBD vs. placebo)
次要结局
- Capsaicin-induced hyperalgesia(10 Days)
研究者
Mohini Ranganathan
Associate Professor of Psychiatry
Yale University