A Trial of Therapeutic Drug Monitoring in Methadone Maintenance Treatment

美沙酮维持治疗中治疗药物监测的试验

• 批准号: nhmrc : 349536
• 负责人: A/Pr James Bell
• 金额: $ 36.14万
• 依托单位: The University of Adelaide
• 依托单位国家: 澳大利亚
• 项目类别: NHMRC Project Grants
• 财政年份: 2005
• 资助国家: 澳大利亚
• 起止时间: 2005-01-01 至 2007-12-31
• 项目状态: 已结题
• 来源: https://researchdata.edu.au/trial-therapeutic-drug-maintenance-treatment/97987
• 关键词: Trial; Therapeutic; Drug; Monitoring; Methadone

Heroin addiction is an established and increasing problem in developed countries and in many developing nations. Although there have been several new treatments for heroin addiction, methadone maintenance remains the most effective way to minimize the harms associated with heroin addiction. The current research proposal seeks to test a new approach to setting of methadone dose, using monitoring of methadone blood levels, effects and side-effects in determining when to increase doses, and when to switch to alternative therapies. This provides an objective method of planning treatment that focuses on suppressing heroin use. The potential subjects of the study are the 50% of patients who continue to use heroin regularly during treatment. All will undergo assessment involving measurement of blood levels of methadone, testing of effects and side-effects of methadone, and monitoring of safety. Half will be randomly allocated to usual care, and half to therapeutic drug monitoring, with dose adjustments according to the results of testing. At 3 and 6 months all subjects will undergo repeat test sessions. It is hypothesized that those in the experimental group will be using less heroin (confirmed by hair testing). It is expected that the study will also identify a small group of subjects with genetically different opioid receptors, who will require very high doses of methadone to be stabilized. The study will allow a detailed analysis of how best to monitor dose adequacy; the relationship between withdrawal symptoms, methadone blood levels, and heroin use, and will provide the first clear investigation of the relationship between changes in methadone blood concentration and certain potentially dangerous changes in the electrical activity of the heart. The intended outcome of this research project is a model for a higher standard methadone program that is more effective in reducing the problems of heroin use in our community.

在发达国家和许多发展中国家，海洛因成瘾是一个既定且日益严重的问题。虽然已经有几种治疗海洛因成瘾的新方法，但美沙酮维持治疗仍然是将与海洛因成瘾有关的危害降至最低的最有效方法。目前的研究提案试图测试一种设定美沙酮剂量的新方法，通过监测美沙酮的血液水平、效果和副作用来确定何时增加剂量，以及何时转向替代疗法。这提供了一种以抑制海洛因使用为重点的计划治疗的客观方法。这项研究的潜在对象是50%的患者，他们在治疗期间继续定期使用海洛因。所有患者都将接受评估，包括测量美沙酮的血液水平，测试美沙酮的效果和副作用，以及监测安全性。一半将被随机分配到常规护理中，另一半将被分配到治疗药物监测中，剂量将根据测试结果进行调整。在3个月和6个月后，所有受试者都将接受重复的测试。据推测，试验组中的人将减少海洛因的使用量(通过毛发测试证实)。预计这项研究还将确定一小部分具有遗传差异的阿片受体的受试者，这些受试者需要非常高剂量的美沙酮才能稳定下来。这项研究将对如何最好地监测剂量充分性、戒断症状、美沙酮血液水平和海洛因使用之间的关系进行详细分析，并将首次明确调查美沙酮血液浓度变化与心脏电活动某些潜在危险变化之间的关系。这项研究项目的预期结果是为更高标准的美沙酮计划提供一个模式，以便更有效地减少我们社区的海洛因使用问题。