Novel Approaches to Opiate Use Reduction

减少阿片类药物使用的新方法

• 批准号: 10292835
• 负责人: KENT E. HUTCHISON
• 金额: $ 62.82万
• 依托单位: UNIVERSITY OF COLORADO DENVER
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-04-01 至 2025-01-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10292835
• 关键词: Acute; Address; Automobile Driving; Biological Assay; Blood; Blood specimen; Cannabidiol; Cannabinoids; Cannabis; Centers for Disease Control and Prevention (U.S.); Climate; Clinical; Clinical Research; Cognitive; Colorado; Complex; Country; Data; Dose; Effectiveness; Epidemic; Future; Glare; Government; Health Personnel; High Prevalence; Individual; Institution; Laboratories; Laws; Legal; Light; Measures; Mediating; Medical; Medical Marijuana; Methodology; Motivation; Observational Study; Opioid; Oral; Outcome; Overdose; Pain; Pain management; Patient Self-Report; Patients; Pharmaceutical Preparations; Pharmacology; Plants; Play; Policy Maker; Population; Prospective Studies; Provider; Public Health; Publishing; Randomized Controlled Trials; Reporting; Research; Role; Safety; Sampling; Sativex; Scientist; Self Administration; Surveys; Testing; Tetrahydrocannabinol; Time; United States; United States National Academy of Sciences; Ursidae Family; Withdrawal; Work; adaptive intervention; base; chronic pain; chronic pain management; chronic painful condition; cognitive function; comparative effectiveness study; craving; experience; innovation; knowledge base; marijuana use; marijuana user; novel strategies; opioid overdose; opioid use; opioid withdrawal; overdose death; pain outcome; pain patient; patient oriented; patient registry; response; secondary outcome; selective attention; side effect; systematic review; therapy design; vehicular accident; virtual

Research Summary The United States is facing an opiate epidemic that is spiraling out of control, with a recent CDC report finding that drug overdoses kill one and a half times more people annually than motor vehicle accidents. This epidemic has been driven, in part, by the high prevalence of chronic pain conditions. The interconnected problems of chronic pain and the opiate epidemic are expected to persist and even worsen in the short term. Given these complex and deadly challenges, patients and medical providers are in desperate need of solutions. Simultaneously, the wide availability of medical and recreational cannabis has increased dramatically within the past decade as a result of legalization in 2 states. Data suggest that management of chronic pain is a driving motivation among medical cannabis users, and recent studies suggest that medical cannabis users report cannabis to be more effective at managing pain as compared to opiates. As a result, pain patients are increasingly turning to cannabis as a form of treatment. At the same time, highly respected institutions like the National Academy of Sciences have published systematic reviews indicating that there is substantial evidence that cannabis products are actually effective in the treatment of pain. Despite the burgeoning body of evidence that supports the idea that cannabis may play a helpful role in the chronic pain and opiate epidemic, prospective studies on the effectiveness and safety profile of cannabis as a treatment for reducing opiate use are virtually non-existent in the U.S. The proposed research is timely and would address a glaring gap in the knowledge base in ways that could potentially have an important public health impact. In light of the current legal climate prohibiting a traditional randomized controlled trial with legal market cannabis products, we propose a patient-centered and highly innovative adaptive intervention design to examine the effectiveness of the cannabis products that patients are already using to reduce reliance on opiates. Consistent with federal laws, we will not be involved in the dispensing of the products and we will not direct the administration or dosing of the products. Our overarching aim is to compare three broad classes of orally administered products (i.e., “edibles”): a THC only product, a product that has a 1:1 THC to CBD ratio, and a CBD only product over the course of 12 weeks in a sample of individuals who want to reduce their opiate use and plan to use cannabis to do so. The primary clinical outcome is opiate use reduction, and the secondary outcome is pain control. We will also conduct acute laboratory sessions in our mobile pharmacology lab to directly examine mechanisms that may mediate the effect of the cannabis products on the clinical outcomes.

研究总结 美国正面临着一种正在失控的鸦片流行病，疾控中心最近的一份报告发现 药物过量每年导致的死亡人数是机动车事故死亡人数的1.5倍。这场流行病 这在一定程度上是由慢性疼痛状况的高患病率推动的。的相互关联的问题 慢性疼痛和鸦片类药物流行预计将持续下去，甚至在短期内恶化。考虑到这些 面对复杂和致命的挑战，患者和医疗提供者迫切需要解决方案。 与此同时，医用和娱乐用大麻的广泛供应在#年急剧增加。 在过去的十年里，由于两个州的合法化。数据表明，慢性疼痛的管理是一种 推动医用大麻使用者的动机，最近的研究表明，医用大麻使用者 报告说，与鸦片类药物相比，大麻在止痛方面更有效。因此，疼痛患者 越来越多地转向大麻作为一种治疗形式。与此同时，备受尊敬的机构，如 美国国家科学院发表了系统的评论，表明有大量证据表明 大麻产品在治疗疼痛方面确实有效。尽管证据层出不穷 这支持了大麻可能在慢性疼痛和鸦片类药物流行中发挥有益作用的观点， 大麻作为治疗减肥药的有效性和安全性的前瞻性研究 鸦片类药物的使用在美国几乎不存在。这项拟议的研究是及时的，将解决 在可能对公共卫生产生重要影响的方式上，知识基础存在明显的差距。在灯光下 当前的法律环境禁止对合法市场的大麻进行传统的随机对照试验 产品，我们提出了以患者为中心和高度创新的适应性干预设计，以检查 患者已经在使用的减少对鸦片类药物依赖的大麻产品的有效性。一致 根据联邦法律，我们不会参与产品的分发，也不会指示 产品的给药或剂量。我们的首要目标是比较三大类口述 受管制产品(即“可食用”)：仅含THC的产品、THC与CBD的比例为1：1的产品，以及 在希望减少阿片类药物使用的样本中，CBD仅在12周内使用产品 并计划使用大麻来做到这一点。主要的临床结果是减少阿片类药物的使用，而次要的 结果是疼痛得到了控制。我们还将在我们的流动药理实验室举行紧急实验室会议，以 直接检查可能调节大麻产品对临床结果的影响的机制。