Adrenergic Agents for Methamphetamine: Outpatient Trials

接受甲基苯丙胺（MA）依赖治疗的患者复发率很高， 还没有药物疗法被证明可以降低这种复发率。针对该适应症的药物治疗试验集中在具有多巴胺能、多巴胺能或混合作用机制的药物。虽然这些药物可能有希望，但越来越多的证据表明，肾上腺素能药物尤其可能有效减少甲基苯丙胺的使用。 为配合这项拨款建议的核心及实验室部分，我们会 两种肾上腺素能药物在甲基苯丙胺门诊患者中的对照临床试验 依赖。 药物治疗试验从深思熟虑的方法中受益匪浅， 开发工作导致，例如，普雷斯顿新使用标准，结果比较 关于成果措施的CPDD-NIDA共识声明）。甲基苯丙胺药物治疗领域没有得到同样程度的方法开发工作的好处。该中心的门诊部分将测试情绪、戒断、压力和渴望指标作为替代标志物的效用，并测试本提案实验室部分开发的定量尿液分析指标的效用。 具体目标： 1.探讨可乐定与卡维地洛治疗海洛因依赖的安全性。 2.比较可乐定和卡维地洛治疗MA的效应量。 3.确定a）情绪，B）甲基苯丙胺戒断，c） 应激，和d）作为甲基苯丙胺依赖性的替代标记的渴望。 4.比较实验室部分开发的定量尿液分析方法 其他成果措施。

Patients treated for methamphetamine (MA) dependence have a high rate of relapse, and no pharmacotherapy has yet been demonstrated to reduce this rate of relapse. Pharmacotherapy trials for this indication have focused on medications with dopaminergic, serotonergic or mixed mechanisms of action. Although such agents may hold promise, an accumulating body of evidence suggests that adrenergic agents in particular may be efficacious in reducing methamphetamine use. Complementing the core and laboratory components of this grant proposal, we will undertake controlled clinical trials of two adrenergic agents in outpatients who are methamphetamine dependent. Cocaine pharmacotherapy trials have benefited considerably from thoughtful methods of development work leading to, e.g., the Preston criteria for new use , a comparison of outcome measures, and a CPDD-NIDA consensus statement on outcome measures). The field of methamphetamine pharmacotherapy has not had the benefit of the same degree of methods development work. The outpatient component of the center will test the utility of measures of mood, withdrawal, stress, and craving as surrogate markers and test the utility of the quantitative urinalysis measures developed in the laboratory component of this proposal. Specific Aims: 1. To determine the safety of clonidine and carvedilol in the treatment of MA dependence. 2. To determine the effect sizes of clonidine and carvedilol in the treatment of MA. 3. To determine the utility of measures of a) mood, b) methamphetamine withdrawal, c) stress, and d) craving as surrogate markers in methamphetamine dependence. 4. To compare the quantitative urinalysis methods developed in the laboratory component of this proposal to other outcome measures.