Cannabidiol Effects on Craving and Relapse Prevention in Opioid Use Disorder

项目摘要/摘要： 为应对阿片类药物滥用和成瘾的国家公共卫生危机，国家 年，健康研究所(NIH)发起了Hear(帮助长期戒除成瘾)倡议 2018年4月，积极推动科学工具的开发，以结束阿片类药物危机 通过FDA加速有效的发现以获得药物批准。医治倡议 未来五年的发展计划预计将产生15个调查性新项目 药物(IND)申请和至少5个新药申请(NDA)。美国国立卫生研究院的治愈者 该计划已在国家药物滥用研究所(NIDA)下发布了这份RFA-DA-19-002 “支持发现和开发预防和治疗阿片类药物使用的药物 紊乱(OUD)和过量用药。 INsys开发公司(INsys)已经开发出大麻二醇口服液，它 显示出作为一种预防复发的新型药物的前景，它解决了五种疾病之一 改善治疗选择的具体机会(机会4)。INsys，在协作中 与KAI Research，Inc.计划启动大麻二醇效应的临床开发计划 论阿片类药物使用障碍的渴求与复吸 UG3/UH3阶段的临床试验： 1.关于UG3阶段，INSYS与首席调查员Edythe London博士合作 (UCLA)将进行一项随机、双盲、安慰剂对照、剂量范围的研究 大麻二酚口服液对线索诱发的渴求、戒断的调节、戒断的改变 尿毒症患者的负性情绪状态、阿片类药物复发和治疗保留 在住宅戒毒所接受丁丙诺啡治疗。调查结果来自 这项研究将用于支持过渡到UH3阶段。 2.对于UH3阶段，INsys与首席调查员医学博士凯瑟琳·布雷迪合作， 博士(MUSC)将在门诊环境下进行两项研究： ·一项随机、双盲、安慰剂对照、平行分组的大麻二醇口服研究 丁丙诺啡+纳洛酮胶囊辅助治疗慢性阻塞性肺疾病 阿片类药物使用障碍。 ·随机、双盲、主动控制、平行分组、双假人、证明- 大麻二醇口服胶囊与纳曲酮作为单一治疗药物的概念比较研究 阿片类药物使用障碍患者的治疗。

Project Summary/Abstract: In response to the national public health crisis of opioid misuse and addiction, the National Institute of Health (NIH) launched the HEAL (Helping to End Addiction Long-term) Initiative in April 2018 to aggressively drive the development of scientific tools that will end the opioid crisis by accelerating effective discoveries through the FDA for drug approval. The HEAL Initiative development programs over the next five years are expected to result in 15 Investigational New Drugs (INDs) applications and at least 5 New Drug Applications (NDAs). The NIH HEAL Initiative has issued this RFA-DA-19-002 under the National Institute on Drug Abuse (NIDA) to “support the discovery and development of medications to prevent and treat opioid use disorders (OUD) and overdose.” INSYS Development Company, Inc. (INSYS) has developed cannabidiol oral solution, which shows promise as a novel medication for prevention of relapse that addresses one of the five opportunities specified to improve treatment options (Opportunity 4). INSYS, in collaboration with KAI Research, Inc., plans to initiate the clinical develop program of Cannabidiol Effects on Craving and Relapse Prevention in Opioid Use Disorder consisting of three proposed clinical trials under the UG3/UH3 Phases: 1. For the UG3 phase, INSYS in collaboration with principal investigator Edythe London, PhD (UCLA) will conduct a randomized, double-blind, placebo controlled, dose-ranging study of cannabidiol oral solution on cue-induced cravings, modulation of withdrawal, alteration in negative affect states, relapse to opioid use, and treatment retention in patients with OUD receiving buprenorphine treatment in a residential drug treatment facility. The findings from this study will be used to support the transition to the UH3 phase. 2. For the UH3 phase, INSYS in collaboration with principal investigator Kathleen Brady, MD, PhD (MUSC) will conduct two studies in an outpatient setting: • A randomized, double-blind, placebo-controlled, parallel-group study of cannabidiol oral capsule as adjunctive therapy to buprenorphine ± naloxone for treatment in patients with opioid use disorder. • A randomized, double-blind, active-controlled, parallel-group, double-dummy, proof-of- concept study of cannabidiol oral capsule compared to naltrexone as monotherapy for treatment in patients with opioid use disorder.