ACTRN12622000634774招募中2 期
A randomised, double-blind, placebo-controlled, cross-over, pilot trial exploring the effects of cannabidiol (CBD) on chronic pain following spinal cord injury
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •(a)Complete or incomplete spinal cord injury as determined using the ASIA scale;
- •(b)Below-level neuropathic pain for minimum 3 months duration;
- •(c)Adult (18 years and over) who is able to provide informed consent; and
- •(d)Proficient in English (must not require an English translator)
排除标准
- •(a) Spinal cord injury in acute stage of recovery (<12 months post-acute spinal cord injury or at the medical doctor’s discretion);
- •(b) If on pain relieving medications must be on stable dose for at least 6 weeks prior to beginning our trial. This includes all prescription medications for pain including opioids or adjuvant pain medications such as Pregabalin, Amitriptyline and SSRIs. Paracetamol and over-the-counter NSAIDs (e.g., ibuprofen, aspirin, naproxen) within the recommended adult dosage permitted as needed. If there has been recent dose titration then we would wait for a stable 6-week period before entering the individual into the trial.
- •(c) If on pain relieving medications, they must not be changed in dosage during the trial period;
- •(d) Cannabis or any other drug or alcohol dependence, as per the International Statistical Classification of Diseases 10th Revision (ICD)-10 criteria or at a medical doctor’s discretion;
- •(e) Reported use of cannabis within the past 3 months (or at the medical officer’s discretion);
- •(f) Urine drug test positive for drugs (cannabis – THC only, meth/amphetamines, and cocaine) at each visit;
- •(g) A history of (self-reported) allergic reaction (e.g. rhinitis, urticaria, contact dermatitis, anaphylaxis) to cannabis, cannabis products or cannabinoids;
- •(h) A history of (self-reported) a clinically significant adverse response to CBD;
- •(i) A history of moderate-to-severe hepatic impairment as determined by the medical doctor;
- •(j) Use of medication(s) that may influence CBD metabolism (e.g. inducers or inhibitors of the CYP450 enzyme system) as determined by the medical doctor;
- •(k) Unable to undergo MRI brain imaging as identified via 'NeuRA MRI Safety Screening Questionnaire';
- •(l) A history of a major psychiatric disorder within the previous 12 months except for clinically managed mild anxiety and/or depression as determined via clinical interview using the Diagnostic and Statistical Manual of Mental Disorders (DSM)-V criteria or at the medical doctor’s discretion;
- •(m) Current suicide ideation as determined via clinical interview with the medical doctor;
- •(n) Pregnancy or lactation - women shall be advised to use reliable contraception for the duration of drug therapy and a urine pregnancy test will be performed where necessary;
- •(o) Patients with quadriplegia secondary to cervical spine injury.
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