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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：
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
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/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

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.

在这个重新提交申请的K23指导病人为导向的研究事业