Dronabinol for the Reduction of Chronic Pain and Inflammation in People With Sickle Cell Disease
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Patient Reported Measurement Outcome Information System (PROMIS) pain impact score
研究概览
简要总结
A randomized, double blind, study of dronabinol as a palliative agent in the treatment of pain, inflammation, and other complications of sickle cell disease (SCD).
详细描述
A randomized, double blind, study of dronabinol as a palliative agent in the treatment of pain, inflammation, and other complications of sickle cell disease (SCD).
Primary Objective: To determine whether dronabinol will improve pain and QOL in adults with SCD and chronic pain.
Secondary Objectives: To assess dronabinol's effect on markers of inflammation in patients with SCD compared to placebo.
To determine the safety and tolerability of dronabinol use in adults with SCD compared to placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Dronabinol and placebo will be over-encapsulated so that neither participants nor investigators are aware of the subjects assignment.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Dronabinol
BID for 8 weeks. Dosage will be individualized per patient. In days 1-4 of the study each patient will be titrated from 5mg bid to a minimum dose of 2.5 mg bid to a maximum dose of 10 mg bid depending on patient preference.
干预措施: Dronabinol (Drug)
Placebo
A placebo comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Patient Reported Measurement Outcome Information System (PROMIS) pain impact score
时间窗: end of study at 8 weeks
Change in Patient Reported Measurement Outcome Information System (PROMIS) pain impact score. Total scale from 20-80, median of 50 and SD of 10. Higher score represent poorer health outcomes.
次要结局
- tumor necrosis factor alpha (TNFα).(end of study at 8 weeks)
- The Leeds assessment of neuropathic symptoms and signs (LANSS) Pain Scale(end of study at 8 weeks)
- Adult Sickle Cell Quality of Life Information System (ASCQ-Me) Pain impact(end of study at 8 weeks)
- Quality of Life Outcomes(end of study at 8 weeks)
- WBC with differential(end of study at 8 weeks)
- C-reactive protein (CRP)(end of study at 8 weeks)
- tryptase(end of study at 8 weeks)
- cytokine IL10(end of study at 8 weeks)
- Vascular cell adhesion protein 1 (VCAM-1)(end of study at 8 weeks)
- cytokine IL1a(end of study at 8 weeks)
- substance P(end of study at 8 weeks)
- cytokine IL1b(end of study at 8 weeks)
- cytokine IL6(end of study at 8 weeks)
- cytokine IL4(end of study at 8 weeks)
- PROMIS domain for nociceptive pain quality(end of study at 8 weeks)
- PROMIS domains(end of study at 8 weeks)
- Columbia suicide severity rating scale(end of study at 8 weeks)
- PROMIS domain for neuropathic pain quality(end of study at 8 weeks)
- Prodromal questionnaire brief version (PQ-B)(end of study at 8 weeks)
研究者
Susanna Curtis
Assistant Professor
Icahn School of Medicine at Mount Sinai