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，主要用于治疗疼痛、焦虑和失眠。 重要的是，有证据表明，一些患者可能正在替代大麻作为减少阿片类药物的策略。 消费然而，大麻作为附表一物质的历史分类（即，受管制物质 没有已知的医疗用途）美国食品和药物管理局（Food and Drug Administration）已设置障碍， 对它在癌症症状管理中的作用进行严格的研究。因此，2021年全国 综合癌症网络的成人癌症疼痛指南指出：“支持使用大麻素的数据 作为辅助镇痛药治疗癌症疼痛是非常有限的， 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的种族差异方面的作用知之甚少。因此，有一个 迫切需要进行严格设计的研究，以产生关于这一现象的新知识。使用 生态瞬时评估（EMA）方法和12个月的前瞻性队列设计，我们建议 在美国东北部的三个卫生系统进行的一项多中心研究。我们将招募600名（每个中心200名）门诊患者 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（每周使用一次， 300名非大麻使用者（过去3个月没有使用）。其中，50%将在 自我认定的非裔美国人患者和50%将是白色。大麻和阿片类药物的使用将通过 EMA（收集1周/月;共84天）和每月电话调查以及患者报告的结局 （PRO）将通过每月电话调查进行评估。这项研究还将描述鲜为人知的 通过阐明受试者内部和受试者之间的动态变化， 在一年的时间里，大麻使用，PRO和阿片类药物使用。具体目标是：（1）描述 受试者内和受试者间大麻使用随时间的动态变化，包括频率、途径、来源 （医疗与非医疗），适应症和成分;（2）评估大麻使用是否与长期使用有关 关键PRO（疼痛严重程度和疼痛相关功能、睡眠、焦虑和生活质量）和阿片类药物使用（主观 和客观指数）;（3）测试大麻使用是否会缓和种族之间的关联 和疼痛严重程度;（4）探索大麻使用，PRO和 阿片类药物的使用，包括大麻的频率，来源，途径和成分，以及目前阿片类药物滥用的措施。 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， 和有关大麻用于癌症疼痛和症状管理的指南可能是基础。坚强 多学科研究团队带来了癌症相关疼痛，医用大麻， 癌症患者中阿片类药物的纵向使用，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.