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.

研究综述 美国正面临着一个阿片类药物的流行，这是螺旋式失控，与最近的疾病控制和预防中心的报告发现， 药物过量每年造成的死亡人数是机动车事故的1.5倍。这次疫情 部分原因是慢性疼痛状况的高患病率。这些相互关联的问题 预计慢性疼痛和鸦片剂流行将持续存在，甚至在短期内恶化。鉴于这些 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，医疗和娱乐大麻的广泛供应在国内急剧增加， 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个 医用大麻使用者的驾驶动机，最近的研究表明，医用大麻使用者 报告说，大麻在控制疼痛方面比阿片类药物更有效。因此，疼痛患者 越来越多地转向大麻作为一种治疗方式。与此同时，备受尊敬的机构，如 美国国家科学院发表的系统性综述表明，有大量证据表明， 大麻产品对治疗疼痛是有效的尽管有越来越多的证据 这支持了大麻可能在慢性疼痛和阿片类药物流行中发挥有益作用的观点， 关于大麻作为减少艾滋病毒/艾滋病治疗的有效性和安全性的前瞻性研究 阿片类药物的使用在美国几乎是不存在的，这项研究是及时的，将解决一个问题。 在知识基础方面存在着明显的差距，可能会对公共卫生产生重要影响。鉴于 当前的法律的环境禁止对法律的市场大麻进行传统的随机对照试验 产品，我们提出了一个以患者为中心的高度创新的适应性干预设计，以检查 这是一项关于患者已经在使用的大麻产品在减少对阿片类药物依赖方面的有效性的研究。一致 根据联邦法律，我们不会参与产品的分发，也不会指导 产品的给药或剂量。我们的首要目标是比较三大类口头 管理的产品（即，“可食用的”）：仅THC的产品，具有1：1的THC与CBD比率的产品，和 CBD唯一的产品在12周的过程中，在一个样本的个人谁想要减少他们的阿片类药物的使用 并计划使用大麻来达到目的主要临床结果是减少阿片类药物的使用， 结果是疼痛控制。我们还将在我们的移动的药理学实验室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影响的机制。