Shared Pharmacotherapeutic Strategies for Cannabinoid & Opioid Use Disorders

大麻素的共同药物治疗策略

基本信息

批准号：
9306809
负责人：
Frances Rudnick Levin
金额：
$ 289.94万
依托单位：
NEW YORK STATE PSYCHIATRIC INSTITUTE DBA RESEARCH FOUNDATION FOR MENTAL HYGIENE, INC
依托单位国家：
美国
项目类别：
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/9306809
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 Human International Laboratories Laboratory Study Marijuana Mentors Mission Nabilone Naltrexone Neurobiology Opioid Opioid Analgesics Patients Pharmaceutical Preparations Pharmacological Treatment Pharmacology Phase Phase II Clinical Trials Pilot Projects Recruitment Activity Relapse Research Research Personnel Research Support Resources Role Running Scientist Signal Transduction Statistical Data Interpretation Substance abuse problem Sum Testing Time Training Training Activity Training and Education Translating Vertebral column Withdrawal Work base cannabinoid treatment clinical practice control trial cost efficient data management evidence base illicit drug use improved innovation marijuana legalization marijuana use marijuana use disorder next generation novel novel strategies opioid use opioid use disorder organizational structure programs public health relevance screening success synergism

项目摘要

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，并且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常见的临床后遗症（即戒断引起的戒断和复发）的能力来检查药物，部分原因是它们具有共同的神经生物学基础。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。所有项目统一为行政核心、研究核心、试点项目核心以及培训和教育核心。在该中心的前 2.5 年中，项目 2 和项目 4 中的 II 期临床试验将测试大麻素/阿片类药物联合策略，将大麻龙和纳曲酮结合用于 CUD 和 OUD。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，可能与大麻龙或丁丙诺啡或缓释纳曲酮组合），以确定要测试的候选药物项目2和4的后续II期临床试验。该中心具有清晰的组织结构，并将以具有成本效益的方式进行。研究团队可用的资源以及机构支持确保成功实现中心的目标。其中包括：1）使用有效的决策算法在实验室中单独和组合测试药物，并将那些显示“阳性”信号的药物快速转移到诊所； 2）在II期对照试验中测试这些实验室“阳性”药物的疗效； 3）探索实验室和临床环境中药物效应的预测因素； 4) 培训初级调查人员成为下一代药物滥用领域的领导者； 5) 在本地、国内和国际范围内传播基于证据的研究成果。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创新进展。我们的创新方法将确保我们的中心具有协同性、转化性并处于药物开发的前沿。总之，该中心致力于使用最有效的方法来寻找潜在的药物来治疗临床上高度关注的两种疾病，即大麻和阿片类药物使用障碍。