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.

项目概要 美国的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 服药过量。慢性疼痛影响着超过 1 亿美国人，阿片类药物经常被用来缓解疼痛 患者控制疼痛。大约 25% 的慢性疼痛患者滥用处方阿片类药物和 大约 10% 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 对慢性疼痛的干预措施和最近的基于人群的研究表明，患者使用大麻来缓解疼痛 宽慰。人们对确定大麻和大麻素产品是否可行有很大兴趣 用于疼痛管理的阿片类药物的替代品。然而，大麻潜在的阿片类药物节约作用是基于 主要是对受回顾性回忆偏差限制的相关结果的研究。研究人员有 指出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 对患有慢性疼痛的患者进行生态瞬时评估（EMA）。 EMA 非常适合收集细 关于药物使用和疼痛的详细数据，具有较低的回忆偏差和较高的生态或现实世界有效性。 R21 探索性研究资助申请的总体目标是开展基于智能手机的研究 使用 EMA 进行实时观察研究，调查阿片类药物使用、大麻使用和 慢性疼痛。 我们组建了一支强大的研究团队，在 EMA、阿片类药物和大麻方面拥有重要的专业知识 研究和慢性疼痛。我们的初步研究表明，我们可以开展 EMA 研究，重点关注 物质使用以及与不同人群的共同使用。此外，我们已经证明许多大麻 用户报告慢性疼痛是他们使用大麻的最重要原因。我们还证明了 慢性疼痛患者的疼痛和阿片类药物的使用存在很大的日常差异，可能是 受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 大麻和阿片类药物在日常使用中的时间相互作用以及这些药物使用之间的关联 物质和疼痛等级。为了实现这些目标，我们将进行一项分为两个阶段的研究。第一阶段将 进行认知访谈以完善 EMA 衡量标准并以 N=20 试行 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 2 阶段将包括对 N=100 名慢性疼痛参与者进行为期 30 天的 EMA 数据收集。