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

莫达非尼可卡因依赖治疗和美沙酮维持中基于凭证的强化治疗 (COMBAT-MM)

• 批准号: G0800370/1
• 负责人: John Strang
• 金额: $ 14.45万
• 依托单位: King's College London
• 依托单位国家: 英国
• 项目类别: Research Grant
• 财政年份: 2008
• 资助国家: 英国
• 起止时间: 2008 至 无数据
• 项目状态: 已结题
• 来源: https://gtr.ukri.org/projects?ref=G0800370%2F1
• 关键词: Cocaine; Dependence; Treatment; Modafinil; Voucher

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.

可卡因是一种强效的非法兴奋剂。英国对这种药物的滥用正在增加，迫切需要开发有效的治疗干预措施。快克可卡因（一种可吸食的毒品，可迅速导致严重成瘾）的使用在寻求美沙酮维持治疗的海洛因使用者中很普遍。在大多数情况下，他们对可卡因的依赖未经治疗。因此，我们设计了一个多中心，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，一种有希望用于可卡因依赖的嗜睡症药物;和（ii）基于凭证的强化疗法（VBRT），一种促进可卡因戒断的动机激励方法。这将是国际上进行的同类可卡因依赖治疗的最大试验之一。在我们工作发展的这一点上，我们正在寻求MRC的资金支持，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。招募模拟。在5个研究中心中的每个研究中心，将进行为期6个月的招募模拟，以评价总体转诊率;可卡因问题患者的比例;符合试验条件的患者数量;不合格或不同意的原因;这些潜在研究受试者至少保留8周;以及MMT常规治疗引起的可卡因使用的结局监测。2（a）.我们将制定一个临床质量标准协议，以确保每个研究中心的依从性，并为标准的关键工作者咨询制定一份具体的治疗手册。2（B）。我们会在试验统筹中心推行一项小规模、不受控制的车辆快速交通试验计划。2（c）.我们将研究VBRT如何减少可卡因的使用，作为戒烟的第一步。3.尿液药物检测替代方法的试点试验。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。交流成果及其应用。我们将向MRC传达试点结果，并将其作为完整支持申请的一部分进行总结。