Extended-Release Mixed Amphetamine Salts for Adults ADHD and Cocaine Dependence

描述（由申请人提供）：未经治疗的注意力缺陷/多动障碍（ADHD）是致残的，并且从其症状和后遗症中出现终身后果，例如，学业成绩受损和更高的物质使用障碍（SUD）发生率。迄今为止，兴奋剂药物是治疗儿童和成人多动症最有效的方法。同样，可卡因依赖也会对个人、社会和经济产生不良影响。目前还没有批准用于治疗可卡因依赖的药物，但越来越多的证据表明，类似“激动剂”的方法可能会带来好处。到目前为止，对成年可卡因依赖多动症患者的即刻和持续释放哌醋甲酯的研究产生了不同的结果，这表明可能需要大剂量的长效安非他明制剂。在这里，我们建议测试两种剂量的缓释混合安非他明盐（ER-MAS）用于治疗可卡因依赖的ADHD患者。我们之所以选择ER-MAS，是因为它的作用时间相对较长，并且在成人ADHD人群中具有耐受性。我们将进行一项2点、3组、双盲随机12周的临床试验，比较安慰剂、60 mg ER-MAS和80 mg ER-MAS。每个站点将有25名患有ADHD的可卡因依赖个体（站点总数：每组75,25名受试者；总人数：150,50 /组）。主要目标将包括：1。测量ER-MAS（每天60或80毫克）缓释和PBO治疗期间可卡因使用的变化。假设：苯甲酰血碱阳性尿液筛查将减少，从80mg>到60mg>PBO的减少最大到最小。测量ER-MAS（60或80毫克/天）缓释和PBO治疗期间ADHD症状的改善。假设：注意缺陷多动障碍（adhd）评定量表将从PBO的80mg / bb1减少到60mg / bb1减少。次要目标将是：1。测量一般功能CGI作为ER-MAS和PBO的函数。假设：与PBO相比，接受右旋安非他明的参与者的CGI评分有更大的提高。测量ER-MAS与PBO期间冲动性的变化。假设：与PBO相比，ER-MAS会降低冲动性，这些冲动性由几种自我报告（巴雷茨冲动性量表）和行为测量（卡片分类，IMT， DMT， BART）测量。这里存在一个几乎独一无二的机会，用一种药物治疗多动症和可卡因依赖这两种疾病，希望能改善这一难以治疗的人群的治疗结果。

DESCRIPTION (provided by applicant): Untreated attention-deficit/hyperactivity disorder (ADHD) is disabling and has life long consequences that emerge from its symptoms and sequelae, e.g., impaired school performance and higher substance use disorder (SUD) rates. To date, stimulant medications are the most effectively way to treat both childhood and adult ADHD. Similarly, cocaine dependence generates problematic individual, social, and economic consequences. There are no approved medications for the treatment of cocaine dependence, but accruing evidence suggests that an 'agonist'-like approach may provide benefit. To date studies of immediate and sustained-release methylphenidate for adult cocaine-dependent individuals with ADHD have produced mixed results, suggesting that high doses of a long-acting amphetamine preparation might be required. Here we propose testing 2 doses of an extended-release mixed amphetamine salt (ER-MAS) for the treatment of cocaine-dependent individuals with ADHD. We have chosen ER-MAS because of its relatively long duration of action and its tolerability in adult ADHD populations. We will conduct a two-site, three-arm, double blind randomized 12 week clinical trial comparing placebo, 60 mg ER-MAS, and 80 mg ER-MAS. There will be 25 cocaine dependent individuals with ADHD at each site (Site total: 75, 25 subject's per group; total N: 150, 50/group). Primary aims will include: 1. Measure change in cocaine use during treatment with ER-MAS (60 or 80 mg per day) sustained release and PBO. Hypothesis: Benzoylecognine positive urine screens will decrease with greatest to least reductions from 80mg>60mg>PBO. Measure improvement of ADHD symptomatology during treatment with ER-MAS (60 or 80 mg per day) sustained release and PBO. Hypothesis: ADHD-Rating Scale will decrease with greatest to least reductions from 80mg>60mg>PBO. Secondary Aims will be: 1. Measure general function CGI as a function of ER-MAS and PBO. Hypothesis: There will be greater improved CGI scores in participants receiving dextroamphetamine compared to PBO. Measure changes in impulsivity during ER-MAS vs. PBO. Hypothesis: ER-MAS will decrease impulsivity as measured by several self-report (Barretts Impulsivity Scale) and behavioral measures (Card Sort, IMT, DMT, BART) compared to PBO. Here a nearly unique opportunity exists to treat two conditions, ADHD and cocaine dependence, with a single medication, hopefully leading to improved treated outcome in this difficult-to-treat population.