A Randomized Controlled Trial of Lorcaserin for the Treatment of Cannabis Use Disorder

在此重新提交的K23指导性患者导向研究职业申请中 发展奖，克里斯蒂娜·布雷泽博士提出了一项全面的发展计划 能够研究并最终定制药理的独立研究人员 借助技术为大麻使用障碍(CUD)患者提供治疗 改进我们的评估和治疗结果。CUD是一种慢性复发-缓解性疾病 这影响了美国数百万成年人。虽然已经有了一些 治疗慢性阻塞性肺疾病的药物治疗的随机对照试验，没有一个出现得如此清楚 很有效。冲动已被认为是CUD的预测因子和后果。 药物治疗试验还没有明确针对这一点。布雷津博士的建议旨在 确定5-羟色胺2c受体激动剂氯卡瑟林减少大麻的有效性 使用和减少冲动的可分离结构，通过行为任务和 在考察访问中和通过生态瞬时评估(EMA)进行自我报告。我们 假设氯卡斯宁组将有更大的大麻使用减少和 与安慰剂相比，各指标的冲动程度都有所降低。该项目将增加 关于冲动在CUD和治疗中的作用的重要且不断增加的文献 为在试验期间利用技术进行体内评估提供了一种策略。 最后，这个项目作为一种收集数据的机制，将为未来奠定基础 在此背景下，为技术进行更大的临床试验和实施努力。在追求这一点的同时 她的导师(弗朗西斯·莱文博士和爱德华·努内斯博士)和 合作者(Valerie Voon博士和Dr.Martina Pavlicova)，Breze博士将同时参与 在个性化培训计划中，以便在以下重要领域得到发展：(1) 临床研究方法(2)临床试验的生物统计学(3)神经生物学和行为学 冲动的评估(4)技术在药物使用治疗中的应用 以及(5)助学金的撰写和管理。该培训计划将建立在Dr。 布雷津的背景是一名获得董事会认证的成瘾精神病学家，他在 物质使用障碍治疗试验，但世卫组织在全面评估方面经验相对较少 冲动和技术应用的不可分离的组成部分。K23大奖将 支持以患者为中心的创新和临床相关研究计划，同时帮助 布雷兹博士获得了关键技能，这将确保她发展成为一名独立的临床医生 研究人员准备影响大麻和其他物质使用障碍治疗领域。

In this resubmission application for a K23 Mentored Patient Oriented Research Career Development Award, Dr. Christina Brezing proposes a comprehensive plan for developing into an independent researcher capable of investigating and, ultimately, customizing pharmacologic treatments for individuals with cannabis used disorder (CUD) with the aid of technology to improve our assessments and treatment outcomes. CUD is a chronic relapsing-remitting illness that impacts millions of adults in the United States. While there have been a number of randomized controlled trials of medication treatments for CUD, none have emerged as clearly efficacious. Impulsivity has been identified as both a predictor and consequence of CUD yet medication treatment trials have not clearly targeted this. Dr. Brezing's proposal aims to determine the effectiveness of lorcaserin, a serotonin 2c receptor agonist, in reducing cannabis use and decreasing dissociable constructs of impulsivity as measured by behavioral tasks and self-report at study visits and through ecological momentary assessments (EMA). We hypothesize that the lorcaserin group will have greater reductions in cannabis use and decreased impulsivity across measures as compared to placebo. The project will add to important and growing literature on the role of impulsivity in CUD and treatment in addition to providing a strategy for harnessing technology to make in vivo assessments during trials. Finally, this project serves as a mechanism to gather data that will lay the groundwork for future largerclinical trials and implementation efforts for technology in this context. While pursuing this line of research with the expertise of her mentors (Drs. Frances Levin and Edward Nunes) and collaborators (Dr. Valerie Voon andDr. Martina Pavlicova), Dr. Brezing will concurrently engage in an individualized training program so as to develop in the following important areas: (1) clinical research methodology (2) biostatistics for clinical trials (3) neurobiology and behavioral assessments of impulsivity (4) applications of technology to the treatment of substance use disorders, and (5) grant writing and management. This training program will build upon Dr. Brezing's background as a board certified addiction psychiatrist who has a growing expertise in substance use disorder treatment trials, but who has relatively little experience in fully assessing dissociable components of impulsivity and applications of technology. The K23 award will support an innovative and clinically relevant program of patient-oriented research, while helping Dr. Brezing acquire critical skills that will ensure her development into an independent clinical researcher poised to impact the field of cannabis and other substance use disorder treatment.