Anticonvulsant Pharmacotherapy for Sedative-Hypnotic Use Disorders

描述（由申请人提供）：本次K23指导患者导向职业发展奖申请的候选人，John J. Mariani，医学博士，要求支持一个为期五年的培训和研究项目，旨在发展药物使用障碍药物治疗临床试验的开发、执行和分析方面的专业知识。马里亚尼博士提出了职业发展活动，这些活动建立在他在精神病学和临床研究方面的背景之上，并利用哥伦比亚大学和纽约州精神病学研究所的资源，帮助他实现成为一名独立研究者的长期目标。作为全面教育计划的一部分，Mariani博士将在生物统计学、临床试验研究设计和后勤、研究伦理行为、手稿准备、拨款写作和管理等方面接受密集的指导和教学。短期目标是掌握随机对照试验的设计、操作和分析技能。马里亚尼博士将通过参与教学和研究的综合教育计划来实现这些目标。拟议的研究计划包括加巴喷丁治疗接受美沙酮维持治疗的苯二氮卓类药物滥用阿片类药物依赖患者的随机双盲、安慰剂对照试验。据估计，接受美沙酮维持治疗的患者中约有三分之一滥用苯二氮卓类药物，目前尚无已知的有效治疗方法。加巴喷丁是一种具有广泛安全范围的抗癫痫药物，在治疗酒精相关疾病方面显示出了希望。由于苯二氮卓类药物和酒精具有相似的作用机制，加巴喷丁作为苯二氮卓类药物使用障碍的潜在药物治疗是一个很好的研究候选者。这项临床研究的开展将建立在Mariani博士之前评估抗惊厥药物作为药物治疗药物使用障碍的工作的基础上。K23指导患者导向职业发展奖的目标是为Mariani博士提供必要的培训和研究经验，使其成为一名独立的研究者。与公共卫生相关：苯二氮卓类药物滥用是接受美沙酮维持治疗的阿片类药物依赖患者的常见问题，目前尚无已知的有效治疗方法。制定有效的治疗战略将对公共卫生产生直接的积极影响。

DESCRIPTION (provided by applicant): The candidate of this K23 Mentored Patient-Oriented Career Development Award application, John J. Mariani, MD, requests support for a five-year program of training and research aimed at developing expertise in the development, execution, and analysis of pharmacotherapy clinical trials for substance use disorders. Dr. Mariani proposes career development activities that build on his background in psychiatry and clinical research and capitalize on the resources of Columbia University and the New York State Psychiatric Institute to aid him achieving the long-term goal of becoming an independent investigator. As part of a comprehensive educational plan, Dr. Mariani will receive intensive mentoring and didactics in biostatistics, clinical trial study design and logistics, the ethical conduct of research, manuscript preparation, and grant writing and management. The short-term goals are to acquire skills in the design, operation and analysis of a randomized controlled trial. Dr. Mariani will reach these goals by engaging in an integrated educational program of didactics and research. The proposed research plan consists of a randomized double-blind, placebo-controlled trial of gabapentin in the treatment of benzodiazepine-abusing opioid-dependent patients receiving methadone maintenance treatment. It is estimated that approximately one-third of patients in methadone maintenance treatment abuse benzodiazepines and there are no known effective treatments. Gabapentin, an antiseizure medication with a wide safety margin, has shown promise in the treatment of alcohol-related disorders. Since benzodiazepines and alcohol have similar mechanisms of actions, gabapentin is an excellent candidate for study as a potential pharmacotherapy for benzodiazepine use disorders. Conduct of this clinical study will build on Dr. Mariani's prior work in evaluating the use of anticonvulsant agents as pharmacotherapies for substance use disorders. The goal of this K23 Mentored Patient-Oriented Career Development Award is to provide Dr. Mariani with the necessary training and research experience to become an independent investigator. Relevance to Public Health: Benzodiazepine abuse is a common problem in opioid-dependent patients receiving methadone maintenance treatment for which there are no known effective treatment. Development of an effective treatment strategy would have a direct positive impact on public health.