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

氯卡色林治疗大麻使用障碍的随机对照试验

基本信息

批准号：
9981722
负责人：
Christina A Brezing
金额：
$ 19.63万
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：
2018
资助国家：
美国
起止时间：
2018-08-01 至 2023-07-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9981722
关键词：
Abstinence Acute Adherence Admission activity Adult Agonist Ambulatory Care Area Behavior Behavior assessment Behavioral Biometry Cannabis Chronic Clinical Clinical Pharmacology Clinical Research Clinical Treatment Clinical Trials Communities Custom Data Development Dopamine Dropout Drug usage Ecological momentary assessment Effectiveness Ensure Evidence based practice Exposure to FDA approved Future Goals Grant Illness impact Impulsivity Incentives Individual Intervention Lead Legal Link Literature Measurement Measures Mediating Medical Mentored Patient-Oriented Research Career Development Award Mentors Mobile Health Application Morbidity - disease rate Motivation Neurobiology Outcome Outpatients Participant Patient Self-Report Patients Performance Personality Pharmaceutical Preparations Pharmacological Treatment Pharmacology Phase Placebos Predisposition Process Psychiatrist Psychotherapy Public Health Randomized Randomized Controlled Trials Relapse Reproducibility Research Research Methodology Research Personnel Research Support Risk Role Serotonin Receptor 5-HT2C Severities Substance Use Disorder System Technology Telephone Time Tobacco smoking behavior Training Training Programs Treatment outcome United States Visit Writing addiction base behavior measurement clinically relevant community setting discontinuation study double-blind placebo controlled trial drug use behavior experience improved in vivo innovation marijuana use marijuana use disorder marijuana user neurobehavioral nicotine use operation patient oriented research pre-clinical programs receptor skills smoking cessation substance abuse treatment time interval tool trait trait impulsivity treatment adherence treatment trial

项目摘要

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.

在此重新提出的K23指导的以患者为导向的研究职业中开发奖，克里斯蒂娜·布雷辛（Christina Brezing）博士提出了一项全面计划，以发展一个独立的研究人员，能够调查并最终定制药理学借助技术治疗大麻二手障碍（CUD）的治疗改善我们的评估和治疗结果。 CUD是一种慢性复发疾病这影响了美国数百万的成年人。虽然有很多 CUD用药治疗的随机对照试验，没有一个清楚地出现有效。冲动性既被认为是CUD的预测因素和后果药物治疗试验尚未明确针对这一点。布雷辛博士的提议旨在确定5-羟色胺2C受体激动剂Lorcaserin在减少大麻方面的有效性通过行为任务和在研究访问和生态瞬时评估（EMA）时进行自我报告。我们假设Lorcaserin组的大麻使用和与安慰剂相比，跨措施的冲动性下降。该项目将添加到关于冲动性在CUD和治疗中的作用的重要和越来越多的文献提供了利用技术在试验期间进行体内评估的策略。最后，该项目是收集将为未来奠定基础的数据的机制在这种情况下，更大的临床试验和实施工作。在追求这一点的同时与她的导师专业知识（Frances Levin和Edward Nunes博士）和合作者（Valerie Voon和Martina Pavlicova博士），Brezing博士将同时参与在个性化的培训计划中，以在以下重要领域发展：（1）临床研究方法（2）临床试验的生物统计学（3）神经生物学和行为冲动性评估（4）技术在治疗物质使用中的应用疾病和（5）授予写作和管理。该培训计划将基于博士。布鲁辛（Brezing）作为董事会认证的成瘾精神病医生的背景，在药物使用障碍治疗试验，但在充分评估方面的经验相对较少冲动性和技术应用的可分离组成部分。 K23奖将支持以患者为导向研究的创新性和临床相关的计划，同时帮助 Brezing博士获得关键技能，以确保她发展成为独立的临床研究人员准备影响大麻和其他药物使用障碍治疗领域。