Cocaine Dependence Treatment with Modafinil and Voucher-based Reinforcement Therapy in Methadone Maintenance (COMBAT-MM)

可卡因是一种强效的非法兴奋剂。这种药物的滥用在英国正在增长，迫切需要开发有效的治疗干预措施。在寻求美沙酮维持治疗（MMT）的海洛因使用者中，快克可卡因（一种可吸食的毒品，可迅速导致严重成瘾）的使用非常普遍。在大多数情况下，他们的可卡因依赖没有得到治疗。因此，我们设计了一项多中心对照临床试验，分别调查两种干预措施的疗效：(i)莫达非尼，一种治疗发作性睡病的药物，有望治疗可卡因依赖；（ii）基于凭证的强化疗法（VBRT），这是一种促进可卡因戒断的动机-激励方法。这将是国际上对可卡因依赖进行的同类治疗中规模最大的试验之一。在我们工作发展的这个阶段，我们正在寻求MRC的资金支持，使我们能够进行试点研究，以支持我们的全面应用。这将使我们能够进行3项研究：1。招聘模拟。在五个地点中的每一个，一个为期6个月的招聘模拟将评估总体推荐率；有可卡因问题的患者比例；符合试验条件的患者人数；不符合资格或不同意的理由；这些潜在研究对象的滞留时间至少为8周；以及照常进行MMT治疗引起的可卡因使用结果监测。2(一个)。我们将为每个站点的依从性制定临床质量标准协议，并为标准关键工作者咨询制定具体的治疗手册。2 (b)。我们将在试验协调中心进行小规模、无管制的自动驾驶车辆试验。2 (c)。我们将研究VBRT如何将减少可卡因使用作为戒烟的第一步。3. 试验尿液药物检测的替代方法。我们将测试现场而不是外部实验室定量BE测试程序的可行性。交流结果及其应用。我们的试验结果将传达给MRC，并总结为完整申请支持的一部分。

Cocaine is a powerful illegal stimulant drug. Abuse of this drug is growing in the UK and there is a pressing need to develop effective treatment interventions. The use of crack cocaine (the smokeable form of the drug which can quickly lead to severe addiction) is widespread among heroin users seekers methadone maintenance treatment (MMT). In most instances their cocaine dependence is untreated. Consequently, we have designed a multi-centre, controlled clinical trial to investigate separately the efficacy of two interventions: (i) modafinil, a medication for narcolepsy which is promising for cocaine dependence; and (ii) voucher-based reinforcement therapy (VBRT), a motivational-incentive approach which promotes cocaine abstinence. This will be one of the largest trials of its kind treatment for cocaine dependence conducted internationally. At this point in the development of our work, we are seeking funding support from MRC to enable us to undertake pilot research to support our full application. This will enable us to conduct 3 studies: 1. A recruitment simulation. At each of five sites, a 6-month recruitment simulation will evaluate the overall referral rate; the proportion of patients with cocaine problems; the number of eligible patients for the trial; the reasons for non-eligibility or non-consent; the retention of these potential study subjects for at least 8 weeks; and outcome monitoring of cocaine use arising from MMT treatment-as-usual. 2(a). We will develop a clinical quality standard protocol for adherence s at each site and also a specific therapeutic manual for standard keyworker counselling. 2(b). We will implement a small-scale, uncontrolled VBRT pilot at the trial co-ordinating centre. 2(c). We will study how VBRT can shape reductions in cocaine use as a first step towards quitting. 3. Pilot-test alternative methods of urine drug-testing. We will test the feasibility of an on-site rather than external laboratory quantitative BE test procedure. Communication of results and their application. Our findings from the pilot will be communicated to MRC and summarised as part of the full application for support.