Atomoxetine in Adolescents with ADHD and SUD

托莫西汀治疗患有 ADHD 和 SUD 的青少年

• 批准号: 6822236
• 负责人: Timothy E Wilens
• 金额: $ 10.71万
• 依托单位: MASSACHUSETTS GENERAL HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-09-28 至 2009-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6822236
• 关键词: adolescence (12-20); attention deficit disorder; behavioral /social science research tag; child psychology; clinical research; clinical trials; cognitive behavior therapy; human subject; human therapy evaluation; longitudinal human study; mental disorder chemotherapy; neurotransmitter antagonist; patient oriented research; psychopharmacology; substance abuse related disorder

DESCRIPTION (provided by applicant): This is the second resubmission of an application for a Midcareer Investigator Award in Patient-Oriented Research (K24) in response to PA-00-005 focused in the areas of Child Psychiatry/Pediatric Psychopharmacology and Addictive Disorders. The overall objectives of the applicant are to a) increase the candidate's knowledge in completing clinical trials in adolescents with substance use disorders (SUD, including drug or alcohol abuse or dependence), b) heighten his involvement in training and mentoring, and 3) complete a five year prospective study of the efficacy of atomoxetine (ATMX) in the treatment of adolescents with Attention- Deficit/Hyperactivity Disorder (ADHD) plus SUD. This Award would also provide an opportunity to develop a well-integrated Center for the diagnosis and treatment of adolescent SUD integrated seamlessly into the pediatric psychopharmacology clinic at the Massachusetts General Hospital (MGH). Substance use disorders constitute one of the most feared outcomes and difficult to manage clinical problems in adolescents with ADHD. High rates of ADHD have been reported in adolescents with SUD. Conversely, untreated ADHD is a risk factor for the development of SUD. Despite this bi-directional overlap, little data are available to guide clinicians in the treatment of ADHD plus SUD in adolescents. ATMX, a recently approved norepinephrine reuptake inhibitor, has been shown to be effective in the treatment of ADHD; however, ATMX remains untested in individuals with SUD. The aim of this research proposal is to evaluate prospectively the efficacy of ATMX in adolescents with ADHD plus SUD. We plan to evaluate systematically adolescents with ADHD plus SUD, treat all of these adolescents with six courses of cognitive behavioral therapy, and randomize youth equally to receive ATMX or placebo. We will evaluate outcome in multiple domains including ADHD, SUD, other psychopathology, and safety parameters throughout the twelve-week trial. In this way, we will follow current clinical guidelines of addressing the SUD prior to ADHD; while accruing valuable information as to the efficacy of a novel non-stimulant medication in treating ADHD, as well as the effects on SUD and functional outcome. This investigation will provide the research template for the five-year award providing an excellent foundation for the applicant to further his own knowledge. Through offsite collaborative efforts, the candidate plans to develop specific skills related to the integration of psycho-social (particularly cognitive-behavioral therapy) and psychopharmacological trials in adolescent SUD trials, and methodological and conceptual issues in the testing of compounds for SUD in adolescents with SUD. The Award would also provide the opportunity for the candidate to expand roles in mentoring residents, Child Psychiatry Fellows, and junior faculty on complementary methodology within Child Psychiatry/Pediatric psychopharmacology and the Addictions. Through didactic seminars, supervision, individual and group meetings, and involvement in ongoing research studies - including the proposed research project - the applicant proposes to systematically mentor individuals at all levels of their training and professional careers in the overlap fields of Child Psychiatry/Pediatric Psychopharmacology and SUD. It is anticipated that trainees will develop skills necessary to further develop their careers independently, thus providing future researchers in a vastly underrepresented area in the fields of Child Psychiatry and Addictions. In this manner, the candidate will satisfy overall career development and mentoring objectives of the K24 award.

描述（由申请人提供）： 这是针对患者研究（K24）的中等职业研究员奖的第二次重新提交，以响应PA-00-005的重点是儿童精神病学/儿科心理药理学和成瘾性疾病。 The overall objectives of the applicant are to a) increase the candidate's knowledge in completing clinical trials in adolescents with substance use disorders (SUD, including drug or alcohol abuse or dependence), b) heighten his involvement in training and mentoring, and 3) complete a five year prospective study of the efficacy of atomoxetine (ATMX) in the treatment of adolescents with Attention- Deficit/Hyperactivity Disorder (ADHD) plus SUD.该奖项还将提供一个机会，以开发一个良好的集成中心，以无缝整合到马萨诸塞州综合医院（MGH）的小儿心理药理学诊所中诊断和治疗。 药物使用障碍构成了ADHD青少年中最令人恐惧的结果之一，难以解决临床问题。在患有SUD的青少年中，已经报道了高动症的高度。相反，未经处理的多动症是SUD发展的危险因素。尽管这两个方向重叠，但很少有数据可指导临床医生在青少年中治疗ADHD Plus SUD。 ATMX是最近经过批准的去甲肾上腺素再摄取抑制剂，已被证明可有效治疗多动症。但是，在患有SUD的个体中，ATMX仍未受过测试。该研究建议的目的是评估ATMX在ADHD Plus SUD的青少年中的疗效。我们计划使用多动症和SUD系统评估青少年，以六种认知行为疗法的培训治疗所有这些青少年，并同样将青年随机随机地接受ATMX或安慰剂。我们将在整个十二周的试验中评估包括多动症，SUD，其他心理病理学和安全参数在内的多个领域的结果。这样，我们将遵循当前的临床指南，以解决多动症之前解决SUD的问题；在获得有关新型非刺激药物治疗多动症的功效以及对SUD和功能结果的影响的有价值的信息。这项调查将为五年奖励提供研究模板，为申请人提供良好的基础，以促进他自己的知识。通过异地协作努力，候选人计划在青少年SUD试验中开发与心理社会（尤其是认知行为疗法）和心理药理试验相关的特定技能，以及在青少年与SUD中SUD的SUD化合物测试中的方法和概念问题。 该奖项还将为候选人提供机会，以扩大指导居民，儿童精神病学研究员和初级教师在儿童精神病学/儿科心理药理学和成瘾中的互补方法学。通过教学研讨会，监督，个人和小组会议，以及参与正在进行的研究（包括拟议的研究项目）的参与，申请人建议在儿童精神病学/儿童精神病学和SUD的重叠领域的各个培训和职业职业中有系统地指导个人。可以预料，学员将开发必要的技能，以进一步独立发展职业，从而为未来的研究人员提供儿童精神病学和成瘾领域中代表性不足的领域。通过这种方式，候选人将满足K24奖的整体职业发展和指导目标。