Pain Response to Cannabidiol in Induced Acute Nociceptive Pain, Allodynia and Hyperalgesia By Using a Model Mimicking Acute Pain in Healthy Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in pain (numeric rating scale (NRS): 0 = no pain and 10 = maximum tolerable pain)
研究概览
简要总结
This study is to investigate the effect of CBD on acute pain in healthy volunteers in a well-established acute pain model.
详细描述
There are no studies investigating Cannabidiol (CBD) in an acute pain model in human beings. This is however of great clinical value because:
- Patients are often treated insufficiently with the commonly used analgesics in acute pain therapy or the available selection of analgesics is limited by their contraindications and side-effects.
- CBD could be an option to optimize pain therapy if the pain relief is not satisfactory.
- CBD in contrast to ∆9-tetrahydrocannabinol (THC) has only few side effects and due to a possible dose reduction of other analgesics patients might benefit from a better side-effect profile.
This study is to investigate the effect of CBD on acute pain in healthy volunteers in a well-established acute pain model.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adults
- •BMI between 18.5 until 25 kg/m2
- •Able to understand the study and the NRS scale
- •Able to give informed consent
排除标准
- •Regular consumption of cannabinoids or other drugs / substances
- •Regular intake of medications potentially interfering with pain sensation (analgesics, antihistamines, calcium and potassium channel blockers, serotonin / noradrenaline reuptake inhibitors, corticosteroids)
- •Neuropathy
- •Chronic pain
- •Neuromuscular disease
- •Psychiatric disease
- •Known or suspected kidney or liver disease
- •Pregnancy/ Lactation
- •Allergy / hypersensitivity to cannabidiol
研究组 & 干预措施
CBD 800 mg p.o.
The study Investigational Medical Product (IMP) is a cannabidiol solution 100 mg/ml 8 ml in single-dose containers for per os administration.
干预措施: CBD 800 mg p.o (Drug)
Placebo p.o.
Participants in the control arm will be receiving a single dose of oral placebo solution 8 ml matched to the active comparator.
干预措施: Placebo p.o (Drug)
结局指标
主要结局
Change in pain (numeric rating scale (NRS): 0 = no pain and 10 = maximum tolerable pain)
时间窗: pain will be assessed every 10 minutes using the NRS from minute 70 to 130
Change in pain for 60 min (from minute 70 to 130) after inducing defined pain in an experimental setting (Koppert model). 2 microdialysis catheters are inserted into intradermal surface of forearm and attached to a constant current stimulator.
次要结局
- Change in area of hyperalgesia (cm)(from minute 70 to 130)
- Change in area of allodynia (cm)(from minute 70 to 130)