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: 7474070
• 负责人: Timothy E Wilens
• 金额: $ 18.04万
• 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 2009-09-14
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7474070
• 关键词: Accounting; Address; Adolescent; Adverse event; Alcohol abuse; Area; Attention deficit hyperactivity disorder; Award; Blinded; Cardiovascular system; Child Psychiatry; Childhood; Clinic; Clinical; Clinical Trials; Cognitive Therapy; Comorbidity; Data; Dependence; Development; Diagnosis; Disease; Disease remission; Drug Interactions; Effectiveness; Faculty; Family; Foundations; Fright; Future; General Hospitals; Group Meetings; Guidelines; Individual; Investigation; Knowledge; Lead; Massachusetts; Mental disorders; Mentors; Methodology; Mid-Career Clinical Scientist Award (K24); Midcareer Investigator Award in Patient-Oriented Research; Mood Disorders; Norepinephrine; Numbers; Outcome; Outpatients; Pharmaceutical Preparations; Placebos; Prospective Studies; Psychopathology; Psychopharmacology; Randomized; Rate; Reporting; Research; Research Personnel; Research Project Grants; Research Proposals; Risk Factors; Role; Safety; Severities; Statistically Significant; Substance Use Disorder; Substance of Abuse; Supervision; Symptoms; Testing; Training; Youth; addiction; atomoxetine; career; follow-up; functional outcomes; improved; inhibitor/antagonist; novel; psychopharmacologic; research study; response; reuptake; skills; social; week trial

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）： 这是针对儿童精神病学/儿科精神药理学和成瘾性疾病领域的 PA-00-005，第二次重新提交以患者为导向的研究 (K24) 中职业生涯调查员奖申请。申请人的总体目标是 a) 增加候选人在完成针对患有物质使用障碍（SUD，包括药物或酒精滥用或依赖）的青少年的临床试验方面的知识，b) 加强他对培训和指导的参与，以及 3) 完成一项为期五年的前瞻性研究，旨在研究阿托莫西汀 (ATMX) 治疗患有注意力缺陷/多动障碍 (ADHD) 和 SUD 的青少年的疗效。该奖项还将提供一个机会，建立一个综合性的青少年 SUD 诊断和治疗中心，并与马萨诸塞州总医院 (MGH) 的儿科精神药理学诊所无缝集成。 药物使用障碍是患有多动症的青少年最可怕的结果之一，也是最难以管理的临床问题。据报道，患有 SUD 的青少年 ADHD 发病率很高。相反，未经治疗的 ADHD 是发生 SUD 的危险因素。尽管存在这种双向重叠，但指导临床医生治疗青少年 ADHD 和 SUD 的数据却很少。 ATMX是最近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；然而，ATMX 尚未在 SUD 患者中进行测试。本研究计划的目的是前瞻性评估 ATMX 对患有 ADHD 和 SUD 的青少年的疗效。我们计划系统地评估患有 ADHD 和 SUD 的青少年，对所有这些青少年进行六个疗程的认知行为治疗，并将青少年平均随机分配接受 ATMX 或安慰剂。我们将在为期 12 周的试验中评估多个领域的结果，包括 ADHD、SUD、其他精神病理学和安全参数。这样，我们将遵循当前的临床指南，在 ADHD 之前解决 SUD；同时积累了有关新型非兴奋剂药物治疗 ADHD 的功效以及对 SUD 和功能结果的影响的宝贵信息。这项调查将为五年奖提供研究模板，为申请人进一步发展自己的知识奠定良好的基础。通过异地协作努力，候选人计划发展与青少年 SUD 试验中的心理社会（特别是认知行为治疗）和精神药理学试验的整合相关的具体技能，以及在青少年中测试 SUD 化合物的方法和概念问题。南德。 该奖项还将为候选人提供扩大指导住院医生、儿童精神病学研究员和初级教师在儿童精神病学/儿科精神药理学和成瘾领域的补充方法方面的作用的机会。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），申请人建议在儿童精神病学/儿科精神药理学重叠领域系统地指导各个级别的个人培训和职业生涯和南苏丹。预计学员将培养进一步独立发展职业生涯所需的技能，从而为儿童精神病学和成瘾领域中代表性严重不足的领域提供未来的研究人员。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。