Parnassia Addiction Research Centre (PARC, Brijder Addiction Treatment), PO Box 53002, 2505 AA The Hague, the Netherlands.
BMC Psychiatry. 2011 Aug 19;11:135. doi: 10.1186/1471-244X-11-135.
Cocaine, particularly in its base form ('crack'), has become one of the drugs of most concern in the Netherlands, being associated with a wide range of medical, psychiatric and social problems for the individual, and with significant public order consequences for society. Available treatment options for cocaine dependent users are limited, and a substantial part of the cocaine dependent population is not reached by the addiction treatment system. Psychosocial interventions for cocaine dependence generally show modest results, and there are no registered pharmacological treatments to date, despite the wide range of medications tested for this type of dependence. The present study (Cocaine Addiction Treatments to improve Control and reduce Harm; CATCH) investigates the possibilities and problems associated with new pharmacological treatments for crack dependent patients.
METHODS/DESIGN: The CATCH-study consists of three separate randomised controlled, open-label, parallel-group feasibility trials, conducted at three separate addiction treatment institutes in the Netherlands. Patients are either new referrals or patients already in treatment. A total of 216 eligible outpatients are randomised using pre-randomisation double-consent design and receive either 12 weeks treatment with oral topiramate (n = 36; Brijder Addiction Treatment, The Hague), oral modafinil (n = 36; Arkin, Amsterdam), or oral dexamphetamine sustained-release (n = 36; Bouman GGZ, Rotterdam) as an add-on to cognitive behavioural therapy (CBT), or receive a 12-week CBT only (controls: n = 3 × 36). Primary outcome in these feasibility trials is retention in the underlying psychosocial treatment (CBT). Secondary outcomes are acceptance and compliance with the study medication, safety, changes in cocaine (and other drug) use, physical and mental health, social functioning, and patient satisfaction.
To date, the CATCH-study is the first study in the Netherlands that explores new treatment options for crack-cocaine dependence focusing on both abstinence and harm minimisation. It is expected that the study will contribute to the development of new treatments for one of the most problematic substance use disorders.
The Netherlands National Trial Register NTR2576The European Union Drug Regulating Authorities Clinical Trials EudraCT2009-010584-16.
可卡因，特别是其碱形式（“快克”），已成为荷兰最受关注的毒品之一，它会给个人带来广泛的医疗、精神和社会问题，并对社会公共秩序产生重大影响。现有的可卡因成瘾者治疗选择有限，且相当一部分可卡因依赖人群未被成瘾治疗系统覆盖。针对可卡因依赖的心理社会干预通常效果有限，而且尽管已经测试了多种药物，但目前尚未有注册的药理学治疗方法。本研究（可卡因成瘾治疗以提高控制和减少危害；CATCH）旨在探索针对快克依赖患者的新的药理学治疗方法的可能性和问题。
方法/设计：CATCH 研究由荷兰三个独立的成瘾治疗机构进行的三项独立的随机对照、开放标签、平行组可行性试验组成。患者为新入组或正在治疗中的患者。共有 216 名符合条件的门诊患者通过预随机双同意设计进行随机分组，接受为期 12 周的治疗，分别为：口服托吡酯（n = 36；Brijder Addiction Treatment，海牙）、口服莫达非尼（n = 36；Arkin，阿姆斯特丹）或口服右苯丙胺控释剂（n = 36；Bouman GGZ，鹿特丹）作为认知行为疗法（CBT）的附加治疗，或仅接受 12 周 CBT（对照组：n = 3×36）。这些可行性试验的主要结局是保留基础心理社会治疗（CBT）。次要结局包括对研究药物的接受度和依从性、安全性、可卡因（和其他药物）使用的变化、身心健康、社会功能以及患者满意度。
迄今为止，CATCH 研究是荷兰首个针对快克可卡因依赖的新治疗方法的研究，重点关注戒除和减少危害。预计该研究将为最具问题的物质使用障碍之一的新治疗方法的发展做出贡献。
荷兰国家试验注册处 NTR2576；欧盟药品监管机构临床试验 EudraCT2009-010584-16。
