Novel Approaches to Opiate Use Reduction

减少阿片类药物使用的新方法

• 批准号: 10333401
• 负责人: KENT E. HUTCHISON
• 金额: $ 62.84万
• 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/10333401
• 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; Persons; 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.

研究摘要 美国正面临着螺旋式失控的优化流行病，最近的一份CDC报告发现 这种药物过量每年杀死的人数比机动车事故高一半。这种流行病 部分是由于慢性疼痛状况的高患病率所驱动的。相互联系的问题 慢性疼痛和优化流行病有望在短期内持续甚至持续。鉴于这些 复杂而致命的挑战，患者和医疗提供者迫切需要解决方案。 同时，医疗和休闲大麻的广泛可用性在内部急剧增加 在两个州合法化的过去十年。数据表明，慢性疼痛的管理是 在医用大麻使用者中推动动力，最近的研究表明医用大麻使用者 与优化相比，报告大麻在管理疼痛方面更有效。结果，疼痛患者是 越来越多地将大麻作为一种治疗形式。同时，像 国家科学院已经发表了系统评价，表明有大量证据 该大麻产品实际上在治疗疼痛方面有效。尽管有大量证据 这支持大麻可能在慢性疼痛中发挥有益作用并优化流行病的想法， 前瞻性研究大麻的有效性和安全性作为减少的治疗方法 在美国，鸦片使用实际上是不存在的，拟议的研究是及时的，将解决 在知识基础上以可能产生重要的公共卫生影响的方式蔓延。在光线下 在当前的法律氛围中，禁止与法律市场大麻进行传统的随机对照试验 产品，我们建议以患者为中心且高度创新的适应性干预设计，以检查 患者已经使用的大麻产品的有效性已用于减少优化的浮雕。持续的 有了联邦法律，我们将不参与产品的分配，我们不会指导 产品的管理或剂量。我们的总体目的是比较三个大型口服 管理产品（即“食用”）：仅THC产品，具有1：1 THC与CBD比的产品和A 在想要减少鸦片使用的个人样本中，CBD仅在12周内仅产品 并计划使用大麻。主要的临床结果是优化的使用降低，次要 结果是控制疼痛。我们还将在移动药理学实验室中进行急性实验室会议 直接检查可能介导大麻产品对临床结果的影响的机制。