Shared Pharmacotherapeutic Strategies for Cannabinoid & Opioid Use Disorders

大麻素的共同药物治疗策略

• 批准号: 8742325
• 负责人: Frances Rudnick Levin
• 金额: $ 266.62万
• 依托单位: NEW YORK STATE PSYCHIATRIC INSTITUTE DBA RESEARCH FOUNDATION FOR MENTAL HYGIENE, INC
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-09-01 至 2019-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8742325
• 关键词: Abstinence; Achievement; Algorithms; Behavioral; Buprenorphine; Cannabidiol; Cannabinoids; Cannabis; Clinic; Clinical; Clinical Trials; Combination Medication; Cost Control; Development; Discipline; Disease; Doxazosin; Drops; Drug Use Disorder; Educational Activities; Effectiveness; Ensure; FDA approved; Faculty; Geographic state; Human; Illicit Drugs; Laboratories; Laboratory Study; Marijuana; Mentors; Mission; Nabilone; Naltrexone; Neurobiology; Opioid; Opioid Analgesics; Patients; Pharmaceutical Preparations; Pharmacological Treatment; Phase; Phase II Clinical Trials; Pilot Projects; Qualifying; Relapse; Research; Research Personnel; Research Support; Resources; Role; Running; Scientist; Signal Transduction; Substance abuse problem; Sum; TNFRSF5 gene; Testing; Time; Training; Training Activity; Training and Education; Translating; Vertebral column; Withdrawal; Work; base; clinical practice; control trial; cost; data management; evidence base; improved; innovation; next generation; novel; novel strategies; organizational structure; programs; public health relevance; screening; success

DESCRIPTION (provided by applicant): There is substantial need for improving the effectiveness of medications for treating opioid use disorder (OUD), plus a considerable need to develop effective medications for cannabis use disorder (CUD). The novel overarching theme of this Center is to examine medications based on their ability to improve clinical sequelae common to both cannabinoid and opioid use disorders (i.e., abstinence-induced withdrawal and relapse), in part due to their shared common neurobiologic underpinnings. This Center consists of 4 Cores and 4 Projects with considerable synergy and interdependency. Unifying all of the Projects are the Administrative Core, the Research Core, the Pilot Project Core, and the Training and Education Core. In the first 2.5 years of this Center, Phase II clinical trials in Project 2 and Project 4 will test the combined cannabinoid/opioid strategy of combining nabilone and naltrexone for both CUD and OUD. Meanwhile, the human laboratory studies in Project 1 and Project 3 will evaluate medications (lorcaserin, cannabidiol, doxazosin, and zonisamide, potentially in combination with nabilone or buprenorphine or sustained-release naltrexone) using a priori decision algorithms to identify candidate medications to be tested in subsequent Phase II clinical trials in Projects 2 and 4. The Center has a clear organizational structure and will b conducted in a cost-efficient manner. The resources available to the research team, along with the institutional support, ensure the success in attaining the Aims of the Center. These include: 1) Use of efficient decision algorithms to test medications alone, and in combination, in the laboratory and move those that show a "positive" signal rapidly into the clinic; 2) Test these "positive" medications from the laboratory for efficacy in Phase II controlled trials; 3) Explore predictors of medication effects in the laboratory and clinic settings; 4) Train junior investigatos to become the next generation of leaders in substance abuse; and 5) Disseminate evidence-based research findings locally, nationally and internationally. This application builds on the strengths and achievements of our research team, while developing innovative advances in shared medications development for cannabinoids and opioids. Our innovative approach will ensure that our Center is synergistic, translational and at the cutting edge of medications development. In sum, this Center is strongly focused on using the most efficient approach to find potential pharmacologic agents to treat two disorders that are of great clinical concern, namely, cannabis and opioid use disorders.

描述（由申请人提供）：非常需要提高治疗阿片类药物使用障碍（OUD）的药物的有效性，另外还非常需要开发治疗大麻使用障碍（CUD）的有效药物。该中心的新的总体主题是根据药物改善大麻素和阿片类药物使用障碍共同的临床后遗症的能力来检查药物（即，戒断诱导的戒断和复发），部分原因是它们共有的共同神经生物学基础。该中心由4个核心和4个项目组成，具有相当大的协同作用和相互依赖性。统一所有项目的是行政核心，研究核心，试点项目核心，培训和教育核心。在该中心的前2.5年中，项目2和项目4的II期临床试验将测试大麻素/阿片类药物联合治疗CUD和OUD的联合策略。同时，项目1和项目3中的人体实验室研究将使用先验决策算法评估药物（氯卡色林、大麻二酚、多沙唑嗪和唑尼沙胺，可能与纳必隆或丁丙诺啡或缓释纳必酮联合使用），以确定在项目2和项目4中后续II期临床试验中待测的候选药物。 该中心有明确的组织结构，并将以具有成本效益的方式开展B活动。研究团队所拥有的资源以及沿着而来的机构支持，确保了中心目标的成功实现。其中包括：1）在实验室中使用有效的决策算法来测试单独和组合的药物，并将那些显示出“阳性”信号的药物迅速转移到临床; 2）在II期对照试验中从实验室测试这些“阳性”药物的功效; 3）在实验室和临床环境中探索药物效果的预测因素; 4）培训初级保健人员成为下一代药物滥用问题的领导人; 5）在地方、国家和国际上传播循证研究结果。 该应用程序建立在我们研究团队的优势和成就的基础上，同时在大麻素和阿片类药物的共享药物开发方面取得了创新进展。我们的创新方法将确保我们的中心是协同的，转化的，并在药物开发的前沿。总之，该中心非常注重使用最有效的方法来寻找潜在的药理学药物来治疗两种临床上非常关注的疾病，即大麻和阿片类药物使用障碍。