Marijuana in Combination With Opioids for Pain and Symptom Control in Hospice Patients
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Primary Reduction of Pain
研究概览
简要总结
Study Objectives: Primary reduction of pain and reduction in overall opioid utilization. Secondary improvement in overall patient well being, weight stabilization with increased appetite, improved oxygen saturation, improvement or prevention of nausea and vomiting.
Study Rationale: To determine optimum use and dosing of medical marijuana (CBD:THC) for pain and symptom management.
Study Population: This study specifically will enroll cancer and non-cancer patients as a primary diagnosis suffering from pain and having a terminal illness (defined as having less than 6 months to live) requiring end of life care.
详细描述
Primary Endpoint: Primary reduction of pain and reduction in overall opioid utilization as evidenced by overall reduction in numeric pain scores and MME (Morphine Milliequivalents)
Secondary and Exploratory endpoints:Secondary improvement in overall patient well being, weight stabilization with increased appetite, improved oxygen saturation, improvement or prevention of nausea and vomiting. Endpoints evaluation will be based on change from Baseline using the Modified Edmonton Assessment Scale.
Study design: This will be an open-label study. Patients will choose to participate in a Marijuana adjuvant treatment group, receiving marijuana in combination with standard opioid therapy.
Subject number: Minimum 66 patients
Treatment Duration: Minimum 5 days
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Age > 18
- •Alert adults
- •requiring opioids for pain management (routine)
- •cancer diagnosis or non-cancer diagnosis as their terminal illness
排除标准
- •pregnant women
- •Age < 18
- •minimally or unresponsive patients unable to take oral medications
- •agitated combative patients
研究组 & 干预措施
Single treatment arm
marijuana adjuvant treatment group utilizing scheduled opioid therapy in inpatient hospice hospital setting
干预措施: Medical Marijuana (Drug)
结局指标
主要结局
Primary Reduction of Pain
时间窗: minumum 3 days
A numeric pain scale (Units on a scale with the higher number indicating worse pain) was used to assess pain from a range of 0 to 10.
Reduction in Overall Opioid Utilization
时间窗: minimum of 3 days
Reduction in overall opioid utilization was measured in units of mg after converting every patient's opioids into equivalent doses (e.g. 2mg of oral dilaudid = 1/4 oral morphine), with a stabilization or reduction in Morphine Mg Equivalents indicating a positive result.
次要结局
- Improvement in Overall Patient Well Being(minimum 3 days)
- Weight Stabilization With Increased Appetite(minimum 3 days)
- Improved Oxygen Saturation(minimum 3 days)
- Reduction or Prevention of Nausea and Vomiting(minimum 3 days)
研究者
Theodore Zanker MD
Principal Investigator
The Connecticut Hospice Inc.