Bupropion VS Placebo to Treat Pathological Gambling

描述(申请人提供)：病态赌博已成为一种 主要健康问题，特别是在赌博机会激增的情况下。 尽管它很重要，但几乎没有被证明有效的治疗方案。 本申请是根据PAR-99-134提交的 “MH干预/研究的探索性/发展补助金” 项目是对安非他酮-SR进行随机、双盲比较 在PG治疗中与安慰剂的比较。安非他酮将被使用，因为它 报道了治疗注意力缺陷多动障碍(ADHD)的疗效， 以及PG和ADHD的临床相似性。这项研究将是 ，并有可能提供试验数据，支持 PG的一种新治疗方法的疗效。我们建议招聘大约80名 在项目的头两年，成人使用DSM-IV PC，并 将受试者随机给予安非他酮-SR或安慰剂进行为期12周的临床试验。 受试者将通过医生推荐、在 当地媒体，并通过口碑传播。受试者将用20个项目进行筛选 南橡树赌博屏幕(SOG)和NORC DSM赌博问题屏幕 (点头)。那些PG筛查呈阳性的人(SOGS得分等于或&>5，NODS得分等于或&gt；5)将被纳入试验，前提是他们符合指定的条件 包含/排除标准。基线评估将包括结构化的 DSM-IV的临床访谈--DSM-IV人格的结构化访谈 障碍，Yale-Brown强迫量表修订后的PG (YBOCS-PG)、Hollinghead量表、NORC赌博自填式问卷和全球评估量表。基线评估还将 包括体检、心电图、尿液药物筛查以及 其他筛查实验室。衡量改善程度的措施将包括 YBOCS-PG，三种临床总体印象量表，患者自评 量表、汉密尔顿抑郁评定量表和注意力缺陷 多动症(ADHD)症状检查表。在为期两周的筛选之后 在此期间，受试者将随机接受药物治疗或安慰剂治疗。安慰剂用量 安非他酮-SR每日两次，每次100毫克，每周增加到每次 每天400毫克。服用安慰剂的受试者将被给予相同数量的药物。 平板电脑。受试者将在第1、2、4、6、8、10和12周接受检查。 每次就诊时将记录事件和伴随的药物。我们 假设接受安非他酮治疗的受试者症状会更好 与接受安慰剂的受试者相比，情况有所改善。此外，我们假设 与注意力缺陷障碍相一致的症状将会同时改善 PG行为的减少。如果安非他酮被确认为有效的 治疗，未来的研究将包括更大的样本，以帮助测试 特定亚组将优先改善，与安非他酮比较 使用SSRI氟伏沙明和阿片类拮抗剂纳曲酮，两者都显示出 对PG有治疗作用。

DESCRIPTION (provided by applicant): Pathological gambling (PG) has become a major health concern, particularly as gambling opportunities have proliferated. Despite its importance, there are few treatment options with proven efficacy. This application is submitted in response to PAR-99- 134 "Exploratory/Development Grants for MH Intervention/Research" The goal of the project is to conduct a randomized, double-blind comparison of bupropion-SR versus placebo in the treatment of PG. Bupropion will be used because of its reported efficacy in treating attention-deficit hyperactivity disorder (ADHD), and clinical similarities between PG and ADHD. This study will be one of the first of its kind, and has the potential to provide pilot data supporting the efficacy of a novel treatment for PG. We propose to recruit approximately 80 adults with DSM-IV PC during the first two years of the project, and to randomize subjects to bupropion-SR or placebo for a 12-week clinical trial. Subjects will be recruited through physician referral, advertisements in the local media, and by word-of-mouth. Subjects will be screened with the 20-item South Oaks Gambling Screen (SOGS) and the NORC DSM Screen for Gambling Problems (NODS). Those screening positive for PG (SOGS score equal to or >5 and NODS score equal to or >5) will be offered inclusion in the trial provided they meet specified inclusion/exclusion criteria. Baseline assessments will include the Structured Clinical Interview for DSM-IV, the Structured Interview for DSM-IV Personality Disorders, the Yale-Brown Obsessive-Compulsive Scale Modified for PG (YBOCS-PG), the Hollingshead Scale, the NORC Gambling Self-Administered Questionnaire, and the Global Assessment Scale. Baseline assessment will also include a physical examination, an electrocardiogram, urine drug screen, and other screening laboratories. Measures to gauge improvement will include the YBOCS-PG, three Clinical Global Impression scale ratings, a patient self-rated scale, the Hamilton Depression Rating Scale, and the Attention Deficit Hyperactivity Disorder (ADHD) Symptom Checklist. Following a two-week screening period, subjects will be randomized to medication or placebo. The dosage of bupropion-SR will begin at 100 mg twice daily and increased weekly to a total of 400 mg daily. Subjects on placebo will be administered a similar number o tablets. Subjects will be seen at weeks 1, 2, 4, 6, 8, 10, and 12. Adverse events and concomitant medications will be recorded at each visit. We hypothesize that the subjects receiving bupropion will have better symptomatic improvement than subjects receiving placebo. Further, we hypothesize that symptoms consistent with attention-deficit disorder will improve in parallel to the reduction in PG behavior. If bupropion is confirmed as an effective treatment, future studies will include larger samples to help test whether specific subgroups will improve preferentially, and comparisons of bupropion with the SSRI fluvoxamine, and naltrexone, an opiate antagonist, both shown to have efficacy in treating PG.