Sustained-Release Methylphenidate For Management of Methamphetamine Use Disorders

缓释哌甲酯用于治疗甲基苯丙胺使用障碍

• 批准号: 8250473
• 负责人: WALTER NMN LING
• 金额: $ 45.61万
• 依托单位: UNIVERSITY OF CALIFORNIA LOS ANGELES
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-02-01 至 2013-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8250473
• 关键词: Abstinence; Acute; Address; Adherence; Adolescent; Adult; Adverse effects; Adverse event; Aftercare; Amphetamine Dependence; Animal Model; Attention deficit hyperactivity disorder; Back; Beck depression inventory; Behavior Therapy; Brain; Bupropion; Clinic; Clinical; Clinical Data; Clinical Research; Cocaine; Cognitive; Cognitive Therapy; Collection; Control Groups; Criminal Justice; Data; Dependence; Development; Diagnostic and Statistical Manual; Disease; Dopamine; Dose; Drug Interactions; Electrocardiogram; Employment Status; Enrollment; Equilibrium; Equipment and supply inventories; European; Evaluation; Exclusion; Experimental Designs; Family; Financial compensation; Frequencies; Funding; Goals; HIV; Health; Human; Incentives; Incidence; Individual; Infection; Life; Ligand Binding; Measures; Medical; Memory; Mental Depression; Methamphetamine; Methamphetamine dependence; Methylphenidate; National Institute of Drug Abuse; Outpatients; Participant; Patient Self-Report; Pharmaceutical Preparations; Pharmacotherapy; Phase; Physical Examination; Placebos; Population; Preclinical Drug Evaluation; Primates; Process; Protocols documentation; Proxy; Psychological reinforcement; Public Health; Ramp; Randomized; Rattus; Recovery; Research; Rewards; Risk; Role; Running; Safety; Sampling; Schedule; Screening procedure; Severities; Sex Behavior; Short-Term Memory; Social Functioning; Social Work; Stimulus; Supervision; Symptoms; System; Testing; Time; Treatment Effectiveness; Treatment Efficacy; Treatment Protocols; Urine; Visual; Work; addiction; analog; base; cocaine use; cognitive function; craving; design; dosage; extracellular; improved; indexing; meetings; methamphetamine abuse; non-drug; novel; placebo controlled study; pre-clinical; prevent; social; stimulant abuse; transmission process; uptake; vesicular monoamine transporter 2

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.

描述（由申请人提供）：这项四年的研究将评估甲基苯甲酸酯治疗的疗效与安慰剂在行为疗法的背景下用于甲基苯丙胺使用障碍（滥用或依赖）在UCLA ISAP ISAP ISAP ISAP ISAP临床临床研究中心寻求治疗的90名成年人中的人群。该项目将采用实验设计，涉及从两种剂量水平的哌醋甲酯水平升起（MPH;一周的18mg/天，每天36mg/天）到假设的有效剂量（54mg/nei，持续8周）。在满足所有包含/排除要求之后，将在最初两周内入学参与者，以加强诊所出勤和尿液样品的收集 - 削减第一个两周的筛查期，只有出勤率就会激励，而没有对三次尿液测试的结果。在整个研究过程中，激励措施的成分一直持续下去，并在药物阶段获得固定的出勤赔偿，并加上增加两个或多个连续两次无药物的尿液样本的奖励的机会增加（磨合后）。相等数量的受试者将被分配给安慰剂或药物，以维持平衡的设计，每条条件有45名受试者。该研究的目的是：目标1。评估持续释放MPH的能力（每天54mg一次，持续8周）减少刺激性滥用，并增加寻求MA使用障碍治疗的成年人样本中的方案中的保留率。目的2。检查持续释放MPH的临床实用性作为甲基苯丙胺使用障碍的药物治疗。目的3。根据精神病，认知，社会和身体领域评估参与者的功能。迫切需要系统地评估治疗甲基苯丙胺使用障碍的策略。因此，该项目解决了NIDA开发有效的刺激使用药物疗法的目标，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了严重后果。公共卫生相关性：拟议的研究具有相当大的公共卫生意义，因为它将提供有关甲基苯丙胺依赖性基于药物治疗的基础信息，这是一个严重的药物问题，具有广泛的影响。如果证明有效，该方案可能有助于减少与药物相关的后果，例如犯罪活动，社会中断和艾滋病毒传播/感染风险升高，这是由于甲基苯丙胺上不安全的性活动的频率增加而导致的。治疗方法的组合可能是最有效的，拟议的项目将评估MPH的实用性与经过验证的行为疗法。