Dronabinol for the reduction of chronic pain and inflammation in people with sickle cell disease

屈大麻酚可减轻镰状细胞病患者的慢性疼痛和炎症

基本信息

批准号：
10676238
负责人：
Susanna Curtis
金额：
$ 19.33万
依托单位：
ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI
依托单位国家：
美国
项目类别：
财政年份：
2022
资助国家：
美国
起止时间：
2022-06-01 至 2026-05-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10676238
关键词：
Address Adult Adverse effects Adverse event Advisory Committees Anti-Inflammatory Agents Anxiety Benefits and Risks Cannabinoids Cannabis Chemicals Clinical Clinical Investigator Clinical Research Clinical Trials Clinical Trials Design Controlled Study Cross-Sectional Studies Data Data Analyses Desire for food Development Development Plans Disease Dizziness Dronabinol Emotional Etiology Event FDA approved Feasibility Studies Fellowship Funding Future Guidelines IL4 gene IL6 gene Incidence Individual Inflammation Inhalation Institution Interleukin-10 K-Series Research Career Programs Knowledge Legal Marijuana Masks Measures Mentored Patient-Oriented Research Career Development Award Mentorship Modeling Moods Nausea Neuropathy Nociception Opioid Oral Organ Outcome Pain Pain Measurement Pain management Participant Patient Self-Report Patients Persons Pharmacologic Substance Placebo Control Placebos Positioning Attribute Procedures Provider Quality of life Randomized Reporting Research Research Personnel Research Project Grants Risk Route Safety Severities Sickle Cell Anemia Sleep Social Impacts Socioeconomic Factors Statistical Data Interpretation Sterility Substance P TNF gene Techniques Terpenes Tetrahydrocannabinol Tissues Translational Research Tryptase cannabinoid treatment capsule career career development chronic pain chronic pain management clinical trial analysis cognitive function cytokine double-masked controlled study efficacious treatment efficacy study experience health care service utilization implementation research improved inflammatory marker inflammatory pain marijuana use marijuana user monocyte mouse model multidisciplinary nerve damage neuroinflammation neutrophil opioid use pain relief painful neuropathy placebo group prevent primary outcome psychologic randomized trial research and development statistics

项目摘要

Dr. Curtis seeks to become an independently funded investigator in sickle cell disease with a focus on the understanding and treatment of chronic pain. Chronic pain is a critical issue for people with sickle cell disease (SCD). This pain is primarily treated with opioids, but for many people with SCD opioids are inadequate to treat chronic pain alone. Cannabinoids (the primary active agents in marijuana) have been shown to be effective for chronic and neuropathic pain and reduce inflammation in non-SCD diseases. Inflammation in SCD is not only correlated with pain but is also correlated with high rates of end organ damage. Over one third of people with SCD say they use cannabis for pain relief, but there is currently no evidence to support this use. Further, there is no evidence to suggest what the adverse effects of this use might be for people with SCD. There are no guidelines for what doctors should tell patients with SCD who ask if cannabis products might help their pain. This proposal seeks to address this gap with a placebo-controlled, double-masked, 8 week-long study of dronabinol, an FDA approval oral agent which contains tetrahydrocannabinol (THC), the primary active ingredient in cannabis. The aims of this study are 1: To determine whether dronabinol will improve pain and QOL in adults with SCD and chronic pain, 2: To assess dronabinol's effect on markers of inflammation in patients with SCD compared to placebo, And 3: To determine the safety and tolerability of dronabinol use in adults with SCD compared to placebo. If dronabinol is found to improve chronic pain, or quality of life, or to reduce markers of inflammation, it should studied in a larger trial. Understanding the safety and tolerability of dronabinol will guide not only future studies but will help clinicians and patients understand some of the possible risks of cannabis use. Through this career development award Dr. Curtis will gain expertise in clinical trial design and execution, longitudinal data analysis and advanced modelling techniques, and clinical and translational aspects of the study of chronic pain. Her advisory committee consists of experts in clinical trial development, pain in SCD, inflammation in SCD, and statistics. Through working with a multidisciplinary mentorship team, the proposed research project, and formal coursework, Dr. Curtis will be able to become an independent clinical investigator with expertise in chronic pain treatment in sickle cell disease.

柯蒂斯博士试图成为镰状细胞病的独立资助的研究者重点是理解和治疗慢性疼痛。慢性疼痛是一个关键问题适用于镰状细胞疾病（SCD）的人。这种疼痛主要用阿片类药物治疗，但许多患有SCD阿片类药物的人仅仅治疗慢性疼痛。大麻素（大麻中的主要活性剂）已显示对慢性和神经性疼痛并减轻非SCD疾病的炎症。 SCD中的炎症不是仅与疼痛相关，但也与较高的终端器官损伤相关。超过一个 SCD患有SCD的人中有三分之一说他们使用大麻缓解疼痛，但目前没有证据支持此用途。此外，没有证据表明这是什么不利影响使用可能适用于SCD的人。没有关于医生应该告诉患者的准则与SCD询问大麻产品是否有助于他们的痛苦。该提议旨在通过安慰剂对照，双掩蔽，8个来解决这一差距长达一周的Dronabinol研究，FDA批准的口服剂，其中含有四氢大麻酚（THC），大麻中的主要活性成分。这项研究的目的是1：确定 Dronabinol是否会改善SCD和慢性疼痛的成年人的疼痛和QOL，2：评估Dronabinol对SCD患者炎症标志物的影响安慰剂和3：确定dronabinol在SCD成年人中使用的安全性和耐受性与安慰剂相比。如果发现dronabinol可以改善慢性疼痛或生活质量，或者减少炎症的标记，应该在更大的试验中进行研究。了解安全性和 Dronabinol的耐受性不仅将指导以后的研究，还将帮助临床医生和患者了解大麻使用的一些可能风险。通过这个职业发展奖，柯蒂斯博士将获得临床试验的专业知识设计和执行，纵向数据分析和高级建模技术以及慢性疼痛研究的临床和翻译方面。她的咨询委员会是临床试验开发，SCD疼痛，SCD炎症和统计的专家。通过与多学科指导团队，拟议的研究项目和正式的课程工作，柯蒂斯博士将能够与镰状细胞疾病中慢性疼痛治疗方面的专业知识。

项目成果

期刊论文数量（7）

专著数量（0）

科研奖励数量（0）

会议论文数量（0）

专利数量（0）

Excess deaths among adults with sickle cell disease in 2020 compared to prior years.

DOI：
10.1007/s00277-022-04994-6
发表时间：
2023-01
期刊：
Annals of hematology
影响因子：
3.5
作者：
Curtis S;Henny B;Joanna S;Betancourt J;Thomas M;Vattappally L;Crouch A;Caterina M
通讯作者：
Caterina M

Is CBD ready for prime time in sickle cell disease?

CBD 准备好迎接镰状细胞病的黄金时期了吗？