Sustained-Release Methylphenidate For Management of Methamphetamine Use Disorders

描述(申请人提供)：这项为期四年的研究将在行为疗法的背景下评估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，使用哌醋甲酯与安慰剂治疗甲基苯丙胺使用障碍(滥用或依赖)的疗效。该项目将采用实验设计，从两种剂量水平的哌甲酸甲酯(mph；每天18毫克，持续一周，每天36毫克，持续一周)增加到假设的有效剂量(每周54毫克，持续8周)。在满足所有纳入/排除要求后，参与者将参加最初两周的研究，以加强诊所就诊和尿样收集--在第一个两周的筛查期内，只有出席受到激励，每周三次尿检的结果不会出现意外情况。激励激励部分在整个研究过程中继续进行，对服药阶段的出席给予固定的补偿，同时增加两个或更多连续的无药物尿样(磨合后)的奖励机会。相同数量的受试者将被分配到安慰剂或药物组，以保持平衡设计，导致每种情况下有45名受试者。这项研究的目的是：1.评估缓释PMH(每天54毫克，连续8周)在寻求治疗MA使用障碍的成年人中减少兴奋剂滥用和增加方案保留率的能力。目的2.研究缓释mph作为甲基苯丙胺使用障碍药物治疗的临床实用性。目的3.从精神、认知、社会和生理领域评估参与者的功能。迫切需要对治疗甲基苯丙胺使用障碍的战略进行系统评估。因此，该项目旨在实现NIDA为兴奋剂使用障碍开发有效药物疗法的目标，兴奋剂使用障碍是一个严重的公共卫生问题，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的潜在药物治疗提供基础信息，甲基苯丙胺依赖是一个影响广泛的严重药物问题。如果被证明有效，该议定书可能有助于减少与毒品有关的后果，如犯罪活动、社会破坏以及由于服用甲基苯丙胺期间不安全性行为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，拟议的项目将结合已证明的行为疗法来评估MPH的有效性。

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.