Real Time Monitoring of Prescription Opioid and Cannabis Co-Use in Patients with Chronic Pain

项目摘要 美国的阿片类药物流行与阿片类药物使用问题的急剧增加有关， 吸毒过量慢性疼痛影响着超过1亿美国人，阿片类药物经常被用来帮助 患者管理疼痛。大约25%的慢性疼痛患者滥用处方阿片类药物， 大约10%的人患有阿片类药物使用障碍（OUD）。 临床实践指南强调非阿片类药物或非药理学药物的重要性 慢性疼痛的干预措施和最近的人口为基础的研究表明，患者使用大麻疼痛， 救灾人们对确定大麻和大麻素产品是否可行很感兴趣 阿片类药物的替代品用于疼痛管理。然而，大麻的潜在阿片类药物节省作用是基于 主要是对相关发现的研究，这些研究受到回顾性回忆偏差的限制。研究人员 注意到需要对这些物质和疼痛的近实时共同使用进行深入的纵向研究 自然环境中的症状。评估阿片类药物和大麻使用模式的新方法 对慢性疼痛患者进行生态瞬时评估（EMA）。EMA非常适合收集精细- 关于物质使用和疼痛的颗粒化数据，具有低回忆偏差和高生态或现实世界有效性。 这项R21探索性研究资助申请的首要目标是进行一项基于智能手机的 一项使用EMA的实时观察性研究，旨在研究阿片类药物使用、大麻使用和 慢性疼痛 我们已经组建了一支强大的调查团队，他们在EMA，阿片类药物和大麻方面具有重要的专业知识 研究和慢性疼痛。我们的初步研究表明，我们可以进行EMA研究，重点是 物质使用和与不同人群共同使用。此外，我们已经证明，许多大麻 吸食者报告说，慢性疼痛是他们吸食大麻的最重要原因。我们还证明， 在慢性疼痛患者中，疼痛和阿片类药物的使用有很大的日常差异， 受其规定性计划以外的因素影响。 本项目的具体目标是：1）制定EMA数据收集方案，并调查 正在使用阿片类药物和大麻的慢性疼痛患者的参与者依从性。2)探索 每日使用大麻和类阿片的时间相互作用以及这些使用之间的关联 物质和疼痛等级。为了实现这些目标，我们将进行一项包括两个阶段的研究。第1阶段将 进行认知访谈，以完善EMA措施，并对N=20的14天EMA数据收集进行试点 参与者，包括后续访谈。EMA问题将根据受试者进行细化和澄清 反馈第2阶段将包括30天EMA数据收集，N=100例慢性疼痛受试者。

PROJECT SUMMARY The opioid epidemic in the US is associated with a dramatic increase in problematic opioid use and overdoses. Chronic pain affects over 100 million Americans and opioids are frequently prescribed to aid patients in managing pain. Approximately 25% of patients with chronic pain misuse prescription opioids and approximately 10% have opioid use disorder (OUD). Clinical practice guidelines stress the importance of non-opioid medications or non-pharmacological interventions for chronic pain and recent population-based studies suggest that patients use cannabis for pain relief. There is considerable interest in determining whether cannabis and cannabinoid products are viable alternatives to opioids for pain management. However, the potential opioid-sparing effect of cannabis is based primarily on studies of correlational findings that are limited by retrospective recall bias. Researchers have noted the need for intensive longitudinal studies on near real-time co-use of these substances and pain symptoms in the natural environment. A novel method to evaluate opioid and cannabis use patterns among patients with chronic pain is Ecological Momentary Assessment (EMA). EMA is ideally suited to collect fine- grained data on substance use and pain, with low recall bias and high ecological or real-world validity. The overarching goal of this R21 exploratory research grant application is to conduct a smartphone-based real-time observational study using EMA to investigate the relationship between opioid use, cannabis use, and chronic pain. We have assembled a strong team of investigators with critical expertise in EMA, opioid and cannabis research, and chronic pain. Our preliminary studies have shown that we can conduct EMA studies focusing on substance use and co-use with different populations. Moreover, we have demonstrated that many cannabis users report chronic pain as the most important reason for their cannabis use. We have also demonstrated that there is substantial day-to-day variability in pain and opioid use among patients with chronic pain and may be influenced by factors other than their prescriptive plan. The specific aims of this project are to: 1) Develop an EMA data collection protocol and investigate participant adherence among chronic pain patients who are using opioids and cannabis. 2) Explore the temporal interplay of cannabis and opioid use on a day-by-day level and associations between use of these substances and pain ratings. To attain these aims, we will conduct a study consisting of 2 phases. Phase 1 will conduct cognitive interviews to refine EMA measures and pilot a 14-day EMA data collection with N=20 participants, including follow-up interviews. EMA questions will be refined and clarified based on participant feedback. Phase 2 will consist of a 30-day EMA data collection with N=100 chronic pain participants.