Cannabis use and outcomes in ambulatory patients with cancer: A 12-month cohort study

项目摘要 在美国，24%-40%的癌症患者使用大麻，主要是为了缓解疼痛、焦虑和失眠。 重要的是，有证据表明，一些患者可能正在将大麻作为减少阿片类药物的一种策略。 消费。然而，大麻作为附表一物质(即受控物质)的历史分类 没有已知的医疗用途)被美国(美国)美国食品和药物管理局为 对其在癌症症状管理中的作用进行严格的研究。因此，2021年国家 综合癌症网络的成人癌症疼痛指南称：“数据支持大麻类药物的使用 作为辅助止痛剂用于治疗癌症疼痛的药物极其有限，根据哪些数据得出的结果 有些矛盾“。此外，尽管有大量证据表明癌症疼痛治疗存在种族差异， 关于大麻在减轻癌症疼痛结果中的种族差异方面的作用，人们知之甚少。因此，有一个 迫切需要进行严格设计的研究，以产生对这一现象的新知识。vbl.使用 生态瞬时评估(EMA)方法和为期12个月的前瞻性队列设计，我们建议 一项在美国东北部三个医疗系统进行的多点研究。我们将招募600人(每个地点200人) 接受阿片类药物治疗的非皮肤实体恶性肿瘤患者：300名大麻使用者(每周使用 前一个月没有吸食任何形式的大麻)和300个不吸食大麻的人(过去3个月没有使用过)。其中，50%将是 自认为是非洲裔美国人的患者，50%将是白人。将通过以下方式评估大麻和阿片类药物的使用 EMA(收集1周/月；总共84天)和每月电话调查和患者报告的结果 (PRO)将通过每月电话调查进行评估。这项研究还将描述那些鲜为人知的 通过阐明受试者内部和受试者之间的动态变化来揭示大麻使用模式随时间变化的现象 在一年的过程中，大麻使用、专业人员和阿片类药物的使用。具体目的是：(1)描述 受试者内和受试者之间大麻使用随时间的动态变化，包括频率、路线、来源 (2)评估长期吸食大麻是否与 主要优点(疼痛严重程度和疼痛相关功能、睡眠、焦虑和生活质量)和阿片类药物的使用(主观 和客观指标)；(3)测试大麻的使用是否缓和了种族之间的联系 和疼痛严重程度；以及(4)探索大麻使用、职业和健康之间关系的潜在调节因素 阿片类药物的使用，包括大麻的频率、来源、路线和成分，以及目前的阿片类药物滥用措施。 这项及时而全面的研究具有很高的潜力，可以产生新的知识，在此基础上进行临床实践 与大麻用于癌症疼痛和症状管理相关的指南可能是基于的。强者 多学科研究团队带来了癌症相关疼痛、医用大麻、 癌症患者的纵向阿片类药物使用、物质滥用和健康差异。总体而言，这 研究可以对癌症疼痛和症状管理的科学产生持续的影响。

PROJECT ABSTRACT Between 24-40% of cancer patients in the U.S. use cannabis, principally to manage pain, anxiety, and insomnia. Importantly, evidence suggests that some patients may be substituting cannabis as a strategy to reduce opioid consumption. However, cannabis’ historical classification as a Schedule I substance (i.e., a controlled substance with no known medical use) by the United States (U.S.) Food and Drug Administration has created barriers to conducting rigorous research on its role in cancer symptom management. As a result, the 2021 National Comprehensive Cancer Network’s Adult Cancer Pain guidelines state: “Data supporting the use of cannabinoids as adjuvant analgesics for treatment of cancer pain are extremely limited and the results from what data exist are somewhat conflicting”. Moreover, despite abundant evidence of racial disparities in cancer pain treatment, little is known about the role of cannabis in mitigating racial disparities in cancer pain outcomes. Thus, there is a critical need to conduct rigorously designed research to generate new knowledge of this phenomenon. Using ecological momentary assessment (EMA) methodology and a 12-month prospective cohort design, we propose a multisite study at three health systems in the northeastern U.S. We will enroll 600 (200 per site) ambulatory patients with non-skin solid malignancies who are receiving opioid therapy: 300 cannabis users (weekly use in any form in the prior month) and 300 cannabis non-users (no use in the past 3 months). Of these, 50% will be self-identified African American patients and 50% will be White. Cannabis and opioid use will be assessed via EMA (collected for 1 week/month; 84 days total) and monthly phone surveys and patient reported outcomes (PROs) will be assessed via monthly phone surveys. This study will also describe the poorly understood phenomenon of cannabis use patterns over time by elucidating dynamic within- and between-subject changes in cannabis use, PROs, and opioid use over the course of one year. The Specific Aims are to: (1) describe dynamic within- and between-subject changes in cannabis use over time including frequency, route, source (medical vs. non-medical), indication, and composition; (2) assess if cannabis use over time is associated with key PROs (pain severity and pain-related function, sleep, anxiety, and quality of life) and opioid use (subjective and objective indices) among cancer patients; (3) test if cannabis use moderates the association between race and pain severity; and (4) explore potential moderators of the relationship among cannabis use, PROs, and opioid use including cannabis frequency, source, route, and composition, and current opioid misuse measure. This timely and comprehensive study has high potential to generate new knowledge upon which clinical practice and guidelines related to cannabis use in cancer pain and symptom management may be based. The strong multidisciplinary research team brings the requisite expertise in cancer-related pain, medical cannabis, longitudinal opioid use among patients with cancer, substance misuse, and health disparities. Overall, this research can have a sustained impact on the science of cancer pain and symptom management.