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

• 批准号: 10440304
• 负责人: Christina A Brezing
• 金额: $ 19.57万
• 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: 2018
• 资助国家: 美国
• 起止时间: 2018-08-01 至 2024-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10440304
• 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; 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; Persons; 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; effectiveness evaluation; experience; implementation efforts; 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; substance use treatment; time interval; tool; trait; trait impulsivity; treatment adherence; treatment trial

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.

在此重新提交申请K23指导患者为导向的研究生涯 发展奖，克里斯蒂娜Brezing博士提出了一个全面的计划，发展成为 一个独立的研究人员能够调查，并最终定制药理学 大麻使用障碍（CUD）患者的治疗， 改善我们的评估和治疗结果。CUD是一种慢性复发缓解性疾病 影响着美国数百万成年人的疾病虽然有一些 CUD药物治疗的随机对照试验，没有一个明显 灵验。冲动性已被确定为CUD的预测因子和后果， 药物治疗试验没有明确针对这一点。Brezing博士的建议旨在 确定氯卡色林（一种5-羟色胺2c受体激动剂）在减少大麻 使用和减少由行为任务测量的冲动性的可分离结构， 在研究访视时和通过生态瞬时评估（EMA）进行自我报告。我们 假设氯卡色林组的大麻使用减少幅度更大， 与安慰剂相比，各项指标的冲动性降低。该项目将增加 关于冲动在CUD和治疗中的作用的重要和不断增长的文献， 提供了一种利用技术在试验期间进行体内评估的策略。 最后，这个项目作为一个机制，收集数据，将奠定基础，为未来 更大规模的临床试验和技术的实施工作。在追求这一目标的同时， 研究与她的导师的专业知识（博士弗朗西斯莱文和爱德华努内斯）和 合作者（瓦莱丽·冯博士和Martina Pavlicova），Brezing博士将同时参与 在个性化的培训计划，以发展在以下重要领域：（1） 临床研究方法学（2）临床试验的生物统计学（3）神经生物学和行为 （4）将技术应用于治疗药物使用 障碍，和（5）赠款的写作和管理。该培训计划将建立在博士。 Brezing的背景是一位委员会认证的成瘾精神病学家，他在以下方面的专业知识越来越多： 物质使用障碍治疗试验，但谁有相对较少的经验，充分评估 冲动的可分离成分和技术应用。K23奖项将 支持创新和临床相关的面向患者的研究计划，同时帮助 博士Brezing获得了关键技能，这将确保她发展成为一个独立的临床医生。 研究人员准备影响大麻和其他物质使用障碍治疗领域。