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）是致残性的，并具有终身的后果，这些后果来自其症状和后遗症，例如，学校表现受损和物质使用障碍（SUD）率较高。迄今为止，兴奋剂药物是治疗儿童和成人ADHD的最有效方法。同样，对可卡因的依赖也会对个人、社会和经济造成严重后果。没有批准的药物用于治疗可卡因依赖，但越来越多的证据表明，“激动剂”样的方法可能会提供好处。到目前为止，立即和持续释放哌醋甲酯的成人可卡因依赖个体多动症的研究产生了混合的结果，这表明可能需要高剂量的长效安非他明制剂。在这里，我们建议测试2剂量的缓释混合安非他明盐（ER-MAS）用于治疗可卡因依赖性ADHD患者。我们选择ER-MAS是因为它的作用持续时间相对较长，并且在成人ADHD人群中具有耐受性。我们将进行一项双中心、三组、双盲、随机、为期12周的临床试验，比较安慰剂、60 mg ER-MAS和80 mg ER-MAS。每个研究中心将有25例可卡因依赖性ADHD患者（研究中心总数：75例，每组25例受试者;总数量：150例，每组50例）。主要目标包括：1。测量ER-MAS（60或80 mg/天）缓释和PBO治疗期间可卡因使用的变化。假设：苯甲酰基麦角碱阳性尿液筛查将从80 mg> 60 mg>PBO以最大到最小的降低降低。测量ER-MAS（每天60或80 mg）缓释和PBO治疗期间ADHD行为学的改善。假设：ADHD评定量表将从80 mg> 60 mg>PBO以最大到最小的降低而降低。第二个目标是：1。测量作为ER-MAS和PBO函数的一般函数CGI。假设：与PBO相比，接受苯丙胺的参与者的CGI评分将有更大的改善。测量ER-MAS与PBO期间冲动的变化。假设：与PBO相比，ER-MAS将降低冲动性，如通过几种自我报告（Barretts冲动量表）和行为测量（卡片分类，IMT，DMT，BART）所测量的。在这里，存在一个几乎独特的机会，用一种药物治疗两种疾病，ADHD和可卡因依赖，希望能改善这种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.