Randomized, Double Blind, Placebo-Controlled Trial to Evaluate the Safety and Tolerability of Cannabidiol (CBD) in Moderate to Severe Rheumatoid Arthritis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 67
- 试验地点
- 1
- 主要终点
- Change from Baseline in Disease Activity Score (DAS28/ESR)
研究概览
简要总结
The study will randomly assign Rheumatoid Arthritis (RA) patients on stable RA therapy to either placebo or cannabidiol (CBD). The overall goal of this proposal is to examine the efficacy and safety of CBD treatment as adjunctive to the medical management of RA patients.
详细描述
This is a randomized, placebo-controlled, double-blind clinical trial at the University of California, Los Angeles evaluating the efficacy, safety, and tolerability of oral cannabidiol (CBD) as adjunctive for rheumatoid arthritis (RA) patients on stable therapy. Patients with moderate to severe RA meeting study inclusion criteria will be randomly assigned to one of three treatment groups (CBD 200 mg BID, CBD 400 mg BID, or placebo). Patients in all groups will receive CBD or placebo under observation for 12 weeks with an additional follow-up phone call occurring 4 weeks after.
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
- •Meet the American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) 2010 Classification Criteria for Rheumatoid Arthritis
- •Disease activity score (DAS28) >= 3.2
- •Age >= 18
- •Stable RA therapy for 12 weeks prior to baseline
- •Power Doppler Score >= 5 (for the PDUS 34 joint score)
- •Must use at least one highly effective method of contraception
- •Written informed consent
排除标准
- •Prior exposure to cannabis <= 28 days prior to baseline
- •Current diagnosed substance use disorders (including Alcohol Use Disorder)
- •Moderate (Child-Pugh B) or severe (Child-Pugh C) hepatic impairment
- •Chronic infections
- •>10mg of prednisone daily use
- •Daily use of central nervous system (CNS) depressant medications (e.g. sedatives, hypnotics [zolpidem, temazepam, alprazolam, lorazepam, diphenhydramine etc.])
- •Women who are pregnant, planning to become pregnant, or breast feeding
- •Sexually active subjects and their partners who are of childbearing potential (ie, neither surgically sterile nor postmenopausal) and not agreeing to use adequate contraception
- •Deemed unsafe by the investigator
- •History of an allergic reaction or adverse reaction to cannabis is exclusionary.
研究组 & 干预措施
Placebo
Participants will take capsules containing medium chain triglyceride (MCT) oil
干预措施: Placebo capsules (Drug)
200mg CBD twice daily
Participants will take capsules containing cannabidiol amounting to 200mg CBD twice daily
干预措施: 200mg Cannabidiol by capsules twice daily (Drug)
400 mg CBD twice daily
Participants will take capsules containing cannabidiol amounting to 400mg CBD twice daily
干预措施: 400mg Cannabidiol by capsules twice daily (Drug)
结局指标
主要结局
Change from Baseline in Disease Activity Score (DAS28/ESR)
时间窗: Baseline, 12 Weeks
The DAS28 is a combined index for measuring disease activity in rheumatoid arthritis (RA). The index includes swollen joint counts (SJC) and tender joint counts (TJC), both scored 0-28 (higher scores indicate higher disease activity), as well as acute phase response (APR) determined as erythrocyte sedimentation rate (ESR), and general health (GH), both scored 1-100 (higher scores indicate higher disease activity). DAS28 was calculated according to the following formula: DAS28 equals (=) \[0.56 multiplied by (\*) the square root (√) of TJC\] plus (+) \[0.28 \* √ of SJC\] + (0.70 \* the natural logarithm (ln) ESR in millimeters per hour (mm/h)\] + \[0.014 \* GH in mm visual analogue assessment (VAS)\]. A negative change from randomization indicated improvement.
Tolerability as assessed by participant attrition
时间窗: 12 weeks
Tolerability will be evaluated based on the number of participants that drop out due to treatment emergent adverse events or serious adverse events.
次要结局
- Change in Power Doppler Synovitis Score (PDUS)(Baseline, 12 weeks)
- Change in Grey Scale Synovial Hypertrophy Score (GSUS)(Baseline, 12 weeks)
研究者
Veena Ranganath, MD, MS
Principal Investigator
University of California, Los Angeles