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

实时监测慢性疼痛患者处方阿片类药物和大麻的共同使用

• 批准号: 9893084
• 负责人: Johannes Thrul
• 金额: $ 20.47万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-03-15 至 2022-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9893084
• 关键词: Address; Adherence; Adult; Affect; Alcohol or Other Drugs use; Alcohols; American; Applications Grants; Behavior; Cannabinoids; Cannabis; Cellular Phone; Characteristics; Clinical Practice Guideline; Control Groups; Correlation Studies; Cross-Sectional Studies; Data; Data Collection; Diabetes Mellitus; Drops; Ecological momentary assessment; Environment; Feedback; General Population; Goals; Grain; Grant; Health Benefit; Heart Diseases; Individual; Intervention; Interview; Longitudinal Studies; Malignant Neoplasms; Measures; Medical Marijuana; Methods; National Institute of Drug Abuse; Observational Study; Opioid; Opioid Rotation; Outcome; Pain; Pain management; Participant; Patient Self-Report; Patients; Pattern; Phase; Pilot Projects; Policies; Population; Population Study; Procedures; Protocols documentation; Public Health; Reporting; Research; Research Personnel; Research Project Grants; Strategic Planning; Stress; Surveys; Target Populations; Time; Tobacco; Work; associated symptom; base; chronic pain; chronic pain management; chronic pain patient; cognitive interview; epidemiology study; evidence base; experience; follow-up; interest; marijuana legalization; marijuana use; marijuana user; non-opioid analgesic; novel; opioid epidemic; opioid overdose; opioid sparing; opioid use; opioid use disorder; opioid user; pain patient; pain relief; pain symptom; patient registry; prescription opioid; prescription opioid misuse; protocol development; real time monitoring; recruit; young adult

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.

项目总结 美国阿片类药物流行与有问题的阿片类药物使用急剧增加有关， 吸毒过量。慢性疼痛影响超过1亿美国人，阿片类药物经常被开来帮助 患者在管理疼痛方面。约25%的慢性疼痛患者滥用处方阿片类药物和 大约10%的人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作用的重要性 慢性疼痛的干预措施和最近的基于人群的研究表明，患者使用大麻治疗疼痛 如释重负。在确定大麻和大麻素产品是否可行方面有相当大的兴趣 用于止痛的阿片类药物的替代品。然而，大麻的潜在的阿片类药物节制作用是基于 主要是对受追溯性回忆偏见限制的相关发现的研究。研究人员已经 注意到需要对这些物质和疼痛的近实时联合使用进行密集的纵向研究 自然环境中的症状。一种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非常适合收集罚款- 关于物质使用和疼痛的颗粒化数据，具有较低的回忆偏差和较高的生态或现实世界有效性。 这个R21探索性研究资助申请的首要目标是进行基于智能手机的 使用EMA进行实时观察性研究，以调查阿片类药物使用、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关键专业知识 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的共同使用。此外，我们已经证明，许多大麻 吸毒者报告说，慢性疼痛是他们使用大麻的最重要原因。我们也证明了 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变异性，并且可能 受他们的规定计划以外的因素影响。 该项目的具体目标是：1)开发EMA数据收集协议并调查 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 每天大麻和阿片类药物使用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。为了达到这些目标，我们将进行一项包括两个阶段的研究。第一阶段将 进行认知访谈以完善EMA指标，并在N=20的情况下试行为期14天的EMA数据收集 参与者，包括后续访谈。EMA问题将根据参与者进行细化和澄清 反馈。第二阶段将包括为期30天的EMA数据收集，N=100名慢性疼痛参与者。