CCRC: The Analgesic Effect of Vaporized Cannabis on Neuropathic Pain
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Participants With 30% or Greater Reduction in Pain Intensity
研究概览
简要总结
This study theorized that a low dose of vaporized cannabis could alleviate nerve injury pain.
详细描述
We conducted a double-blind, placebo-controlled, crossover study evaluating the analgesic efficacy of vaporized cannabis in subjects, the majority of whom were experiencing neuropathic pain despite traditional treatment. Thirty-nine patients with central and peripheral neuropathic pain underwent a standardized procedure for inhaling medium-dose (3.53%), low-dose (1.29%), or placebo cannabis with the primary outcome being visual analog scale pain intensity. Psychoactive side effects and neuropsychological performance were also evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age greater than 18 and less than 70
- •Visual Analogue Scale (VAS pain intensity) greater than 3/10
- •A negative urine drug screening test, i.e., no evidence of IV drug abuse
- •Neuropathic pain due to reflex sympathetic dystrophy, peripheral neuropathy, post-herpetic neuralgia, post-stroke pain, multiple sclerosis or spinal cord injury
排除标准
- •Presence of another painful condition of greater severity than the neuropathic pain condition which is being studied.
- •Subjects with moderate-severe major depression, bipolar/mania, bipolar II/hypomania and schizophrenia or schizoaffective disorder.
- •Unstable Type 1 or 2 diabetes defined as blood glucose more than 156 mg/dl
- •History of traumatic brain injury
- •Uncontrolled medical condition, including coronary artery disease, hypertension, cerebrovascular disease, asthma, tuberculosis (TB), chronic obstructive pulmonary disease (COPD), opportunistic infection, malignancy requiring active treatment, active substance abuse (alcohol or injection drugs).
- •Current use of marijuana (e.g., within 30 days of randomization)
- •Pregnancy as ascertained by a self-report and a mandatory commercial pregnancy test.
研究组 & 干预措施
Mild dose cannabis
3.53% THC by weight
干预措施: Mild dose cannabis (Drug)
Low dose cannabis
1.29% THC by weight
干预措施: Low dose cannabis (Drug)
Placebo cannabis
placebo marijuana
干预措施: Cannabis (Drug)
结局指标
主要结局
Participants With 30% or Greater Reduction in Pain Intensity
时间窗: baseline to six hours
The primary outcome variable, VAS Pain Intensity, was assessed by asking participants to indicate the intensity of their current pain on a 100-mm visual analog scale (VAS) between 0 (no pain) and 100 (worst possible pain).An assessment was performed before the administration of vaporized cannabis or placebo and hourly thereafter for six hours.
次要结局
- Visual Analogue Scale Pain Intensity Scores for Baseline and up to 5 Hours Following Administration of Vaporized Cannabis(baseline to six hours)