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: 10201541
• 负责人: Christina A Brezing
• 金额: $ 19.6万
• 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 2023-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10201541
• 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; 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.

在这份重新提交 K23 指导患者导向研究职业的申请中 发展奖，克里斯蒂娜·布雷辛博士提出了一项全面的计划，以发展成为 能够调查并最终定制药理学的独立研究人员 借助技术对大麻使用障碍 (CUD) 患者进行治疗 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 这影响着美国数百万成年人。虽然已经有不少 CUD 药物治疗的随机对照试验，没有一个结果如此明确 有效。冲动已被确定为 CUD 的预测因素和后果 药物治疗试验尚未明确针对这一点。 Brezing 博士的提议旨在 确定氯卡色林（一种血清素 2c 受体激动剂）在减少大麻方面的有效性 使用和减少可分离的冲动结构（通过行为任务和 在研究访问和通过生态瞬时评估（EMA）进行自我报告。我们 假设氯卡色林组将更大程度地减少大麻的使用，并且 与安慰剂相比，各项措施的冲动性均有所降低。该项目将添加到 关于冲动在 CUD 和治疗中的作用的重要且不断增长的文献 提供利用技术在试验期间进行体内评估的策略。 最后，该项目作为收集数据的机制，为未来奠定基础 在这方面进行更大规模的临床试验和技术实施工作。在追求这一点的同时 凭借她的导师（弗朗西斯·莱文博士和爱德华·努内斯博士）的专业知识进行了一系列研究 Brezing 博士将同时参与合作者（Valerie Voon 博士和 Martina Pavlicova 博士） 个性化培训计划，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 冲动评估 (4) 技术在药物滥用治疗中的应用 (5) 拨款写作和管理。该培训计划将以博士为基础。 Brezing 是一名经过委员会认证的成瘾精神病学家，在这方面拥有越来越多的专业知识 物质使用障碍治疗试验，但在全面评估方面经验相对较少 冲动的可分离成分和技术的应用。 K23奖将 支持以患者为中心的创新和临床相关的研究计划，同时帮助 Brezing 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。