Sustained-Release Methylphenidate For Management of Methamphetamine Use Disorders

描述（由申请人提供）：这项为期四年的研究将在加州大学洛杉矶分校ISAP门诊临床研究中心寻求治疗的90名成年人中评价哌甲酯与安慰剂相比在甲基苯丙胺使用障碍（滥用或依赖）行为治疗背景下的疗效。该项目将采用一种实验设计，包括从两种剂量水平的哌甲酯（MPH; 18 mg/天，持续一周，36 mg/天，持续一周）逐渐增加到假设的活性剂量（54 mg/周，持续8周）。在满足所有入选/排除要求后，受试者将在最初两周内入组研究，以加强门诊就诊和尿样采集-在前两周筛选期间，仅鼓励就诊，每周三次尿检结果无意外事件。激励激励部分在整个研究过程中持续存在，在用药阶段为出勤提供固定补偿，同时为连续两次或更多次无药物尿液样本（磨合后）增加奖励的机会不断增加。将相同数量的受试者分配至安慰剂组或药物组，以保持平衡设计，因此每种疾病45例受试者。本研究的目的是：目的1。评价缓释MPH（54 mg，每日一次，持续8周）在寻求MA使用障碍治疗的成人样本中减少兴奋剂滥用和增加方案保留的能力。目标二。研究缓释MPH作为甲基苯丙胺使用障碍药物治疗的临床效用。目标3：评估参与者在精神、认知、社会和身体领域的功能。迫切需要对治疗甲基苯丙胺使用障碍的战略进行系统评价。因此，该项目涉及NIDA的目标，即开发一种有效的药物治疗兴奋剂使用障碍，这构成了一个相当大的公共卫生问题，对社会服务系统，刑事司法系统以及数百万个人和家庭造成严重后果。公共卫生相关性：拟议的研究具有相当大的公共卫生意义，因为它将为甲基苯丙胺依赖性的潜在药物治疗提供基础信息，甲基苯丙胺依赖性是一个具有广泛影响的严重毒品问题。如果证明有效，该议定书可能有助于减少与毒品有关的后果，如犯罪活动、社会混乱和因服用甲基苯丙胺期间不安全性活动频率增加而增加的艾滋病毒传播/感染风险。治疗方法的组合可能是最有效的，拟议的项目将评估MPH与经证实的行为疗法相结合的效用。

DESCRIPTION (provided by applicant): This four-year study will evaluate the efficacy of treatment with methylphenidate compared to placebo in the context of behavioral therapy for methamphetamine use disorders (abuse or dependence) in a population of 90 adults seeking treatment at the UCLA ISAP Outpatient Clinical Research Center. The project will employ an experimental design involving ramping from two dosage levels of methylphenidate (MPH; 18mg/day for one week, and 36mg/day for one week) to the hypothesized active dosage (54mg/week for 8 weeks). After satisfying all inclusion/exclusion requirements, participants will be enrolled into the study for an initial two weeks for reinforcement of clinic attendance and collection of urine samples--during the first two-week screening period, only attendance is incentivized, with no contingency on results of thrice-weekly urine tests. The motivational incentives component continues throughout the study, with fixed compensation for attendance during the medication phase, in conjunction with escalating opportunities of increased reward for two or more consecutive drug-free urine samples (post run-in). Equal numbers of subjects will be assigned to either placebo or medication to maintain a balanced design, resulting in 45 subjects per condition. Aims of the study are: Aim 1. To evaluate the ability of sustained-release MPH (54mg once daily for 8 weeks) to reduce stimulant abuse and increase retention in the protocol among a sample of adults seeking treatment for MA use disorders. Aim 2. To examine the clinical utility of sustained-release MPH as a pharmacotherapy for methamphetamine use disorders. Aim 3. To assess functioning of participants in terms of psychiatric, cognitive, social, and physical domains. There is a critical need for systematic evaluation of strategies for treating methamphetamine use disorders. Thus, this project addresses NIDA's goal of developing an effective pharmacotherapy for stimulant use disorders, which constitute a considerable public health problem with severe consequences to social service systems, the criminal justice system, and to millions of individuals and families. PUBLIC HEALTH RELEVANCE: The proposed research is of considerable public health significance in that it will provide foundational information on a potential medication-based treatment for methamphetamine dependence, a serious drug problem with extensive impacts. If proven effective, the protocol could be useful in reducing drug-related consequences such as criminal activity, social disruption, and elevated risk of HIV transmission/infection due to increased frequency of unsafe sexual activities while on methamphetamine. A combination of treatment approaches may be most effective, and the proposed project will assess the utility of MPH in combination with proven behavioral therapy.