Cannabis Oil for Pain Effectiveness
试验速览
- 阶段
- 2 期
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Sustained pain response
研究概览
简要总结
This project represents a first systematic, prospective, single-arm cohort study of a safe and effective dosing regimen of an orally administered cannabis oil formulation in a cancer subject population with poorly controlled pain.
详细描述
Over a 1-2 year period, 40 cancer patients experiencing poorly controlled pain will be enrolled in to a prospective single-arm cohort study, in which they will receive an orally administered cannabis oil formulation as an add-on therapy to current treatment regimens. Subjects entering the acute study phase will be titrated to a tolerated dose at which a sustained pain response is reached, and may subsequently enter a 12 week chronic phase during which safety and durability of pain response will be assessed at their stable dose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women with breast, prostate, lung, gastrointestinal or genitourinary cancer who have poorly controlled pain defined by the use of three or more PRN, or as needed, doses of opioids in a 24-hour period for a minimum of three days per week in the week prior to study registration.
- •Age 25-70 years.
- •An ESAS score of 2 or more recorded as their worst pain at the time of study registration.
排除标准
- •Current use of cannabis within the last 30 days from date of study consent (urine screen test positive).
- •Brain metastases.
- •ECOG performance >
- •Life expectancy < 6 months.
- •Daily morphine milligram equivalent (MME) dose < 15 or >
- •Current major psychiatric illness, such as bipolar disorder, major depression, active suicidal intent or psychosis that could be exacerbated by the administration of cannabis.
- •Chemotherapy induced neuropathy.
- •Poorly controlled hypertension, unstable angina, or myocardial infarction within the previous 6 months.
- •Known history or presence of any clinically significant hepatic, renal/genitourinary, gastrointestinal, cardiovascular (e.g. arrhythmias, ischemic heart disease, tachycardia), cerebrovascular, pulmonary, endocrine, immunological, musculoskeletal, neurological, psychiatric (e.g. depression, disorientation, euphoric mood and dissociation), dermatological or hematological disease or condition unless determined as not clinically significant.
- •Women who are not practicing an effective form of birth control (condoms, diaphragm, birth control pill, IUD) or are currently pregnant or lactating.
- •Anticipated change in chemotherapy or radiotherapy treatment plan during the 43-day course of the acute study.
- •Known history of substance abuse.
- •Inability to speak or read English.
- •Inability to provide informed consent.
研究组 & 干预措施
MRCP001
MRCP001 administered per protocol dose titration regimen (beginning at 1 capsule daily, titrated to a maximum of 3 capsules BID)
干预措施: MRCP001 (Drug)
结局指标
主要结局
Sustained pain response
时间窗: 43 days (Acute Phase)
Two successive pain responses (Reduction in pain as measured by the Brief Pain Inventory - Short form (BPI-SF) with no increase MME or decrease in MME, continuing for 7 days after dose stabilization)
次要结局
- Anxiety and depression(43 days (Acute Phase) + 12 weeks (Chronic Phase))
- Neuropathic pain(43 days (Acute Phase) + 12 weeks (Chronic Phase))
- Quality of life change(43 days (Acute Phase) + 12 weeks (Chronic Phase))
- Pain response at any time(43 days (Acute Phase) + 12 weeks (Chronic Phase))
- Toxicity of treatment intervention - incidence and grade of AEs(43 days (Acute Phase) + 12 weeks (Chronic Phase))
- Functional well-being(43 days (Acute Phase) + 12 weeks (Chronic Phase))