Medications Development for Cannabis-Use Disorders: Clinical Studies

大麻使用障碍的药物开发：临床研究

• 批准号: 8675214
• 负责人: Joshua Anthony Lile
• 金额: $ 9.75万
• 依托单位: UNIVERSITY OF KENTUCKY
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-07-01 至 2016-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8675214
• 关键词: Abstinence; Address; Admission activity; Adopted; Adverse effects; Agonist; Area; Attenuated; Baclofen; Behavioral Sciences; Biological Assay; Brain; CNR1 gene; Cannabinoids; Cannabis; Cannabis Smoking; Clinical; Clinical Data; Clinical Research; Clinical Treatment; Clinical Trials; Commit; Communities; Controlled Clinical Trials; Data; Dependence; Development; Development Plans; Diagnostic; Disease; Dose; Drug Combinations; Drug usage; Ecology; Environment; Foundations; Funding; Future; Goals; Gold; Grant; Hybrids; Illicit Drugs; Independent Scientist Award; Individual; Inpatients; Institution; Kentucky; Knowledge; Laboratories; Laboratory Procedures; Laboratory Research; Link; Maintenance; Measures; Mediating; Mentors; Methods; Monitor; Nabilone; Neurons; Neuropharmacology; Outpatients; Persons; Pharmaceutical Preparations; Pharmacological Treatment; Pharmacotherapy; Phase; Population; Procedures; Process; Productivity; Public Health; Publications; Relapse; Reporting; Research; Research Training; Resistance; Resources; Risk; Safety; Sampling; Screening procedure; Self Administration; Series; Solid; Stimulus; System; Testing; Therapeutic; Time; Toxicology; Training; Treatment Efficacy; Treatment outcome; United States; Universities; Urine; Withdrawal; absorption; base; career; career development; clinical efficacy; clinical practice; cost effective; drug discrimination; drug of abuse; efficacy evaluation; efficacy testing; endogenous cannabinoid system; evidence base; experience; gabapentin; gamma-Aminobutyric Acid; improved; innovation; interest; meetings; next generation; post-doctoral training; post-market research; programs; responsible research conduct; safety testing; screening; skills; tiagabine

DESCRIPTION (provided by applicant): Cannabis is the most commonly used illicit drug in the United States, and its use is associated with rates of development of abuse and dependence, treatment admission and relapse that are comparable to other illicit drugs. Currently there is no effective pharmacological treatment for cannabis-use disorders. The overarching goal of my career is to develop a clinical research program in which I am able to screen potential medications for cannabis-use disorders using an efficient, evidence-based progression of laboratory procedures followed by an evaluation of the efficacy of promising leads in dependent, treatment-seeking individuals. My graduate and post-doctoral training and K01 and R01 support have enabled me to build an independent research program in which rational targets for medications development are identified based on the neuropharmacology of 9-THC. My research has identified compounds that could represent major breakthroughs in cannabis-use treatment. The goal of this K02 award is to continue my career development trajectory by acquiring the additional skills and experience needed to move my research into the next steps of the screening process. In order to achieve this goal, I have formulated a career development plan that includes additional coursework, training with expert preceptors, relevant research and data publication/presentation activities, further grant development, and the receipt and delivery of training in the responsible conduct of research. The research to be conducted during the funding period consists of a three-step screening process to 1) identify targets and/or specific compounds for subsequent screening; 2) test the safety and tolerability of cannabis administration during maintenance on candidate medications; and 3) test the ability of maintenance on putative pharmacotherapies to attenuate the reinforcing effects of cannabis under controlled laboratory conditions while simultaneously monitoring changes in cannabis use in the natural ecology. Importantly, this last step represents an innovative approach that will enhance the efficiency of early phase clinical trial research, direct the choice of candidate medications for full scale clinical efficacy testing, and facilitate my eventual transition to clinical trials research. This research will be carried out in the Department of Behavioral Science at the University of Kentucky, which is an exceptional environment, having the necessary physical and intellectual resources for successful completion of the proposed career development plan. Moreover, this institution is committed to my scientific development and has acknowledged that my research program is an integral part of its scientific community. I have a solid foundation of training and research experience, have established a strong record of productivity and independent funding, and have demonstrated a commitment to mentoring the next generation of scholars interested in the treatment of cannabis-use disorders. The career development activities supported by the K02 award will allow me to sustain and expand these efforts, and thus meet my career goals, which will directly impact the field of cannabis-use treatment.

描述（由申请人提供）：大麻是美国最常用的非法药物，其使用与与其他非法药物相当的滥用和依赖，治疗入院和复发的发展率有关。目前尚无对大麻疾病的有效药理治疗。我职业生涯的总体目标是制定一项临床研究计划，在该计划中，我能够使用有效的，基于证据的实验室程序的进展来筛查潜在的大麻使用药物，然后评估有前途的促进性，寻求治疗，寻求治疗的人。我的研究生和博士后培训以及K01和R01的支持使我能够建立一个独立的研究计划，在该计划中，基于9-THC的神经药物学确定了药物开发的合理目标。我的研究已经确定了可以代表大麻治疗中主要突破的化合物。该K02奖的目标是通过获得将我的研究转移到筛选过程的下一步的其他技能和经验，以继续我的职业发展轨迹。为了实现这一目标，我制定了一项职业发展计划，其中包括其他课程，专家主持人的培训，相关的研究和数据出版/演示活动，进一步的赠款发展以及负责任的研究进行培训。在资金期间进行的研究包括三步筛选过程，以确定靶标和/或特定化合物以进行后续筛查； 2）测试在维持候选药物期间大麻施用的安全性和耐受性； 3）测试对推定药物疗法的维护能力减弱在受控实验室条件下大麻的增强作用，同时监测自然生态学中大麻使用的变化。重要的是，最后一步代表了一种创新的方法，该方法将提高早期临床试验研究的效率，指导选择候选药物进行全尺度临床疗效测试，并促进我最终过渡到临床试验研究。这项研究将在肯塔基大学的行为科学系进行，这是一个特殊的环境，拥有成功完成拟议的职业发展计划的必要物理和智力资源。此外，该机构致力于我的科学发展，并承认我的研究计划是其科学界不可或缺的一部分。我为培训和研究经验提供了坚实的基础，已经建立了生产力和独立资金的良好记录，并表现出致力于指导对治疗大麻疾病的下一代学者的承诺。 K02奖支持的职业发展活动将使我能够维持和扩大这些努力，从而实现我的职业目标，这将直接影响大麻使用治疗领域。