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

• 批准号: 10668871
• 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
• 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/10668871
• 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; Double-Blind Method; Dronabinol; Emotional; Etiology; Event; FDA approved; Feasibility Studies; Fellowship; Funding; Future; Guidelines; IL4 gene; IL6 gene; Incidence; Individual; Inflammation; Inhalation; 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 management; Pain quality; Participant; Patient Self-Report; Patients; Persons; Pharmacologic Substance; Placebo Control; Placebos; Positioning Attribute; Procedures; Provider; Psychological Factors; 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; Sum; TNF gene; Techniques; Terpenes; Tetrahydrocannabinol; Tissues; Translational Research; Tryptase; cannabinoid treatment; capsule; career; career development; chronic neuropathic pain; chronic pain; chronic pain management; clinical trial analysis; cognitive function; cytokine; 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; randomized trial; research and development; statistics

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.

柯蒂斯博士寻求成为一名独立资助的镰状细胞病研究人员 重点是对慢性疼痛的理解和治疗。慢性疼痛是一个关键问题 镰状细胞病（SCD）的治疗方法。这种疼痛主要用阿片类药物治疗，但对于 许多患有SCD的阿片类药物不足以单独治疗慢性疼痛。大麻素（Cannabinoids） 大麻中的主要活性剂）已被证明对慢性和 神经性疼痛和减少非SCD疾病中的炎症。SCD中的炎症不是 不仅与疼痛有关，而且与终末器官损伤的高发生率有关。通过一 三分之一的SCD患者表示他们使用大麻缓解疼痛，但目前没有证据表明 支持这种使用。此外，没有证据表明这会产生什么不良影响。 可能对SCD患者有用。对于医生应该告诉病人什么，没有指导方针 SCD患者询问大麻产品是否有助于缓解疼痛。 本提案旨在通过安慰剂对照、双盲、8 一项为期一周的屈大麻酚研究，屈大麻酚是一种FDA批准的口服药物，含有四氢大麻酚 (THC)是大麻的主要活性成分。本研究的目的是：1.确定 屈大麻酚是否会改善SCD和慢性疼痛成人的疼痛和QOL，2： 评估屈大麻酚对SCD患者炎症标志物的影响， 安慰剂和3：确定屈大麻酚用于SCD成人的安全性和耐受性 与安慰剂相比。如果发现屈大麻酚可改善慢性疼痛或生活质量， 减少炎症标志物，应该在更大的试验中进行研究。了解安全性和 屈大麻酚的耐受性不仅将指导未来的研究，而且将帮助临床医生和患者 了解使用大麻的一些可能风险。 通过这个职业发展奖，Curtis博士将获得临床试验方面的专业知识 设计和执行，纵向数据分析和先进的建模技术，以及 慢性疼痛研究的临床和转化方面。她的顾问委员会由 临床试验开发、SCD疼痛、SCD炎症和统计学方面的专家。 通过与多学科导师团队合作，拟议的研究项目，以及 正式的课程，柯蒂斯博士将能够成为一名独立的临床研究者， 镰状细胞病慢性疼痛治疗的专业知识。