Analgesic Effects of a Treatment With Cannabis Sativa Extract in Patients With Knee Osteoarthritis - CANOA (Cannabis for Osteoarthritis)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Pain levels
研究概览
简要总结
Osteoarthritis (OA) is the most prevalent joint disease in humans, often causing disability in affected individuals, especially the elderly. OA is characterized by mechanical joint pain, crepitus and short-term post-immobilization stiffness. OA pain has a variable pathophysiology and, despite the many pharmacological options available, its treatment is often ineffective and has significant side effects. The search for more effective and safer treatments is therefore essential in the field of OA. Among the possible treatments are substances derived from cannabis. Cannabis plants have been used for various purposes by humankind for thousands of years. Its best-known species, Cannabis sativa, has more than a hundred substances called cannabinoids or, more specifically, phytocannabinoids, the most important of which is cannabidiol (CBD). Although many pre-clinical studies indicate the usefulness of phytocannabinoids, clinical evidence for their application is currently scarce. Therefore, this project aims to investigate the effects of a CBD-rich extract of Cannabis sativa on the pain of patients with knee OA, as well as the possible adverse events of this treatment.
详细描述
Osteoarthritis (OA) is the most common osteoarticular pathology in humans. In Brazil, in 2004, its prevalence was estimated at 4.14% of the population , and is likely even higher today, given the country's accelerated aging and the increasing prevalence of obesity.
The pain of OA has variable pathophysiology, with nociceptive, inflammatory, and neuropathic mechanisms, along with central and peripheral sensitization, being the main cause of functional disability in patients.
Currently, the pharmacological therapeutic arsenal for treating OA pain includes non-steroidal anti-inflammatory drugs (NSAIDs), opioids, and intra-articular corticosteroids. However, their use is associated with undesirable adverse effects, more common in the geriatric population, which is already exposed to polypharmacy. Due to the heterogeneity of pain pathophysiology in OA, no medication is fully effective in its control, and combinations of different classes of drugs with diverse mechanisms of action are generally employed, along with non-pharmacological measures such as patient education, rehabilitation, and, when necessary, surgical interventions .
Several studies demonstrate that cannabis has antiemetic, appetite-stimulating, analgesic, euphoric, anti-inflammatory, anticonvulsant, and sedative effects. Pain is the main cause of functional disability in patients affected by OA. Modulation of the endocannabinoid system through CB1 and CB2 receptor agonists, as well as FAAH inhibitors, has shown antinociceptive effects in animal models of OA induced by monosodium iodoacetate (MIA) , collagen , and adjuvants , as well as in models of natural OA in guinea pigs.
Other preclinical studies have shown potential effects of cannabinoids on OA progression, such as the inhibition of enzymes that produce local inflammatory mediators, such as nitric oxide and prostaglandin E2 , matrix metalloproteinases , and modulation of cortisol-mediated synovial fibroblast adhesion .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a diagnosis of knee osteoarthritis, according to the ACR classification criteria (ALTMAN, 1986);
- •Have a moderate or high level of pain induced by osteoarthritis (visual analog scale scale equal to or greater than 5);
- •Voluntarily agree to take part in the study by signing the Informed Consent Form (ICF);
- •For women of reproductive age, a negative Beta-HCG test, and use of a contraceptive method throughout the study.
- •For women of reproductive age, a negative Beta-HCG test, and use of a contraceptive method throughout the study and 3 months after its conclusion.
- •Age range of thirty (30) to seventy (70) years.
排除标准
- •People with heart failure, hypertension or any heart disease;
- •People with chronic kidney disease or liver failure;
- •Patients with chronic inflammatory diseases;
- •Patients with severe psychiatric illnesses, such as severe mood disorders and psychotic disorders;
- •Current use of cannabinoids by any route of administration.
- •Pregnant women
- •Lactating women
结局指标
主要结局
Pain levels
时间窗: 2 months
Change in pain levels, according to the score in the "pain" domain of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), using the Likert scale to assign a value to the answers obtained from the participants. The pain levels according to the score are 0-8 mild, greater than 8-14 moderate, greater than 14- 20 high.
次要结局
- Short Form Health Survey (SF-12)(2 months)
- Change in sleep quality(2 months)
- Depression(2 months)
- Renal Function Panel(2 months)
- Visual Analogue Scale (VAS)(2 month)
- Adverse events(2 months)
- Serious adverse events(2 months)
- Hepatic Panel(2 month)
- Depression(2 months)
- Adverse events(2 months)
- Serious adverse events(2 months)
- Change in sleep quality(2 months)