A Randomized, Double-blind, Placebo-controlled Study to Investigate the Effects and Mechanisms of a High CBD Cannabis Extract (BRC-002) for the Treatment of Pain and Health in Complex Regional Pain Syndrome
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Change in complex regional pain syndrome pain and heat pain measured with VAS
研究概览
简要总结
The aim of this trial is to determine the potential effects and mechanisms of cannabinoid-induced pain relief in complex regional pain syndrome (CRPS). Multiple psychophysical approaches will be conducted in conjunction with psychological and inflammatory marker testing to determine if and how cannabinoids produce stabilized improvement in CRPS-related pain and comorbidities.
The trial consisted of a pre-treatment screening period, six-week treatment period and a two-week follow-up.
详细描述
Complex Regional Pain Syndrome (CRPS) is a debilitating and perplexing chronic pain condition that produces incalculable suffering to millions of individuals worldwide. The enigmatic nature of CRPS has left it difficult to treat. CRPS is characterized by a constellation of pain, sensory, autonomic, and motor symptoms that is difficult to pinpoint the source of injury/inflammation. Although unclear, a common cause of CRPS are radial fractures that demonstrate aberrant processing 4-6 weeks after injury.
The aim of this trial is to determine the potential effects and mechanisms of cannabinoid-induced pain relief in complex regional pain syndrome (CRPS). Multiple psychophysical approaches will be conducted in conjunction with psychological and inflammatory marker testing to determine if and how cannabinoids produce stabilized improvement in CRPS-related pain and comorbidities.
The trial consisted of a pre-treatment screening period, six-week treatment period and a two-week follow-up.
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
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of signed and dated informed consent form.
- •Are between 21-75 years old
- •Ability to communicate in English
- •Volunteers with no previous medical history (e.g., cardiac or pulmonary disease)
- •Are not currently using any type of cannabis, including hemp or CBD
- •Currently 30 days cannabis free
- •Participants with ongoing CRPS [Type 1 or Type 2)] for at least 3 months prior to participation (medical record confirmed)
- •Agrees not to use cannabis, including hemp or CBD, outside of the study during participation in the study
- •Agrees not to use opioids or barbiturates during participation in the study
排除标准
- •Fail cannabis screening
- •Active pulmonary disease
- •Allergy or past adverse effects or negative past experiences from cannabis
- •Positive urine drug test for THC, barbiturates, opioids, oxycodone, or methadone prior to study session 1 or session 2
- •Any significant illness, including cardiovascular disease, diabetes, renal and liver disease
- •Any current or history of an immunocompromising disease or condition (such as lupus, psoriasis, multiple sclerosis, etc.)
- •Any current or history of neurologic conditions, including Parkinson disease, dementia, cognitive impairment, history of seizure disorder, and history of traumatic brain injury/head injury
- •Participant meets DSM-V criteria for current major psychiatric illness, such as bipolar disorder, major depression, psychosis, substance use disorder, or schizophrenia
- •Any current or history of suicidal ideation or attempt
- •Patients with clinically significant laboratory abnormalities
研究组 & 干预措施
Placebo Comparator: 1 Placebo
Half of the patients will receive PO placebo
干预措施: BRC-002 Placebo (Drug)
Experimental: Active
Drug: BRC-002 (High Cannabidiol Botanical Extract) 100 mg/mL
干预措施: BRC-002 (Drug)
结局指标
主要结局
Change in complex regional pain syndrome pain and heat pain measured with VAS
时间窗: Day 1 - Day 42
Change from baseline in pain intensity and unpleasantness ratings using an 11-point Visual Analog Scale in response to heat and ongoing CRPS pain
次要结局
- Sleep Measure(Day 1 - Day 42)
- Interleukin 6(Day 1 - Day 42)
- Pain Inventory Measure(Day 1 - Day 42)
- Depression Measure(Day 1 - Day 42)
研究者
Fadel Zeidan
Associate Professor
University of California, San Diego