Cannabis Oil for Pain Effectiveness
关键词
抽象
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.
日期
| 最后验证: | 08/31/2019 |
| 首次提交: | 04/26/2018 |
| 提交的预估入学人数: | 05/09/2018 |
| 首次发布: | 05/10/2018 |
| 上次提交的更新: | 09/22/2019 |
| 最近更新发布: | 09/24/2019 |
| 实际学习开始日期: | 07/24/2018 |
| 预计主要完成日期: | 05/31/2020 |
| 预计完成日期: | 08/31/2020 |
状况或疾病
干预/治疗
Drug: MRCP001
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Experimental: MRCP001 MRCP001 administered per protocol dose titration regimen (beginning at 1 capsule daily, titrated to a maximum of 3 capsules BID) | Drug: MRCP001 MRCP001 is a formulated whole-plant cannabis oil extract, that may help manage poorly controlled chronic pain. |
资格标准
| 有资格学习的年龄 | 25 Years 至 25 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: 1. 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. 2. Age 25-70 years. 3. An ESAS score of 2 or more recorded as their worst pain at the time of study registration. Exclusion Criteria: 1. Current use of cannabis within the last 30 days from date of study consent (urine screen test positive). 2. Brain metastases. 3. ECOG performance > 2. 4. Life expectancy < 6 months. 5. Daily morphine milligram equivalent (MME) dose < 15 or > 120. 6. Current major psychiatric illness, such as bipolar disorder, major depression, active suicidal intent or psychosis that could be exacerbated by the administration of cannabis. 7. Chemotherapy induced neuropathy. 8. Poorly controlled hypertension, unstable angina, or myocardial infarction within the previous 6 months. 9. 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. 10. Women who are not practicing an effective form of birth control (condoms, diaphragm, birth control pill, IUD) or are currently pregnant or lactating. 11. Anticipated change in chemotherapy or radiotherapy treatment plan during the 43-day course of the acute study. 12. Known history of substance abuse. 13. Inability to speak or read English. 14. Inability to provide informed consent. |
结果
主要结果指标
1. Sustained pain response [43 days (Acute Phase)]
次要成果指标
1. Pain response at any time [43 days (Acute Phase) + 12 weeks (Chronic Phase)]
2. Toxicity of treatment intervention - incidence and grade of AEs [43 days (Acute Phase) + 12 weeks (Chronic Phase)]
3. Anxiety and depression [43 days (Acute Phase) + 12 weeks (Chronic Phase)]
4. Functional well-being [43 days (Acute Phase) + 12 weeks (Chronic Phase)]
5. Quality of life change [43 days (Acute Phase) + 12 weeks (Chronic Phase)]
6. Neuropathic pain [43 days (Acute Phase) + 12 weeks (Chronic Phase)]
