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

可卡因是一种强力的非法兴奋剂。在英国，这种药物的滥用正在增长，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)的海洛因吸毒者中，使用强效可卡因(毒品的可吸烟形式，很快就会导致严重上瘾)的情况很普遍。在大多数情况下，他们的可卡因依赖得不到治疗。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有效性：(I)莫达非尼，一种有望治疗可卡因依赖的发作性睡病药物；(Ii)基于凭证的强化疗法(VBRT)，一种促进可卡因戒除的激励-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一点上，我们正在寻求MRC的资金支持，以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。在五个地点中的每个地点，为期6个月的招募模拟将评估总体转诊率；有可卡因问题的患者比例；符合试验条件的患者数量；不符合条件或不同意的原因；这些潜在研究对象至少保留8周；以及对MMT照常治疗引起的可卡因使用的结果监测。2(A)。我们将制定临床质量标准规程，在每个地点坚持S，并为标准的关键工作者咨询制定专门的治疗手册。2(B)。我们将在试验协调中心实施小规模、无控制的VBRT试点。2(C)。我们将研究VBRT如何影响可卡因使用量的减少，作为戒烟的第一步。3.试行尿液药物测试的替代方法。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。成果的交流及其应用。我们的试点结果将被传达给MRC，并作为完整的支持申请的一部分进行总结。

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.