CBD Treatment in Hand Osteoarthritis and Psoriatic Arthritis. A Randomized, Double-blind Placebo Controlled Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 136
- 试验地点
- 1
- 主要终点
- VAS pain during the last 24 hours
研究概览
简要总结
A randomized, placebo-controlled trial with blinded outcome assessments will be conducted to evaluate the efficacy and safety of CBD in patients with Hand-OA and PsA during a 12-week treatment period.
详细描述
A randomized, placebo-controlled trial with blinded outcome assessments will be conducted to evaluate the efficacy and safety of CBD in patients with Hand-OA and PsA during a 12-week treatment period.
Aim: To assess the effect of CBD on visual analogue scale pain measurements at 12 weeks compared with placebo.
Patients and controls: Patients with Hand-OA or PsA and VASpain during the last 24hours of 30mm or more.
Primary outcome: Changes in VAS pain during the last 24 hours from baseline to 12 weeks. Measured with a 100mm VAS from the most symptomatic hand (Hand-OA) or joint (PsA).
Safety outcomes
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Concurrent diagnosis of chronic regional pain syndrome or neuropathy
- •Other known inflammatory rheumatic disease (i.e. rheumatoid arthritis, gout not in remission)
- •Other known disease where exacerbations need to be treated with systemic corticosteroids (i.e. certain types of inflammatory bowel disease) or patients who have received systemic corticosteroid treatment during the last 3 months.
- •Planning pregnancy, pregnant or breastfeeding. (Fertile women will be tested for pregnancy)
- •Planned major surgery or recent major surgery (last 8weeks)
- •Addictive behaviour or previously addictive behaviour defined as abuse of cannabis, opioids or other recreational or pharmaceutical drugs. Determined through patient interview and medical records.
- •Contraindication to medical cannabis (Known allergy to ingredients, history of severe liver or kidney disease, history of schizophrenia or other serious psychiatric disease).
- •Verified malignant disease
- •History of epilepsy or severe cramps
- •History of serious cardiovascular pathology
- •Lacking ability to corporate with the research staff.
- •Indication for changing the anti-inflammatory treatment regimen at baseline (PsA only).
研究组 & 干预措施
Intervention
10mg Cannabidiol (CBD) tablets once daily for the first two weeks increasing to twice daily for week 3 and 4 if adequate analgesic effect is not attained at week 5 then the dose can be increased to 10mg thrice daily from week 5 and onward.
干预措施: Cannabidiol (Drug)
Placebo
10mg Placebo Oral tablets once daily for the first two weeks increasing to twice daily for week 3 and 4 if adequate analgesic effect is not attained at week 5 then the dose can be increased to 10mg thrice daily from week 5 and onward.
干预措施: Placebo Oral Tablet (Drug)
结局指标
主要结局
VAS pain during the last 24 hours
时间窗: Change from baseline to 12 weeks
Measure with a 100mm Visual Analogue Scale (VAS) with higher values indicating more pain.
次要结局
未报告次要终点
研究者
Jonathan Vela
Jonathan Vela MD
Aalborg University Hospital