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Cocaine Addiction Treatments to improve Control and reduce Harm (CATCH): New Pharmacological Treatment Options for Crack-Cocaine Dependence in the Netherlands

机译:可卡因成瘾疗法可改善控制和减少危害(CATCH):荷兰破解可卡因依赖的新药理治疗选择

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Background 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. Discussion 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. Trial Registration The Netherlands National Trial Register NTR2576 The European Union Drug Regulating Authorities Clinical Trials EudraCT2009-010584-16
机译:背景可卡因,特别是其基本形式(“裂纹”),已成为荷兰最受关注的药物之一,与个人的广泛医疗,精神病和社会问题有关,并具有重大的公共秩序后果为社会。可卡因依赖使用者的可用治疗选择受到限制,成瘾治疗系统无法达到可卡因依赖人群的很大一部分。尽管对可卡因依赖进行了广泛的心理测试,但对可卡因依赖的社会心理干预措施总体上显示出适度的结果,迄今为止,尚无注册的药物治疗方法。本研究(可卡因成瘾疗法可改善控制和减少危害; CATCH)研究了针对裂纹依赖型患者的新药理疗法的可能性和问题。方法/设计CATCH研究由三个独立的随机对照,开放标签,平行分组的可行性试验组成,在荷兰三个独立的成瘾治疗机构进行。患者是新的转诊患者或已经接受治疗的患者。总共216名符合条件的门诊患者使用随机双前同意设计进行随机分组,并接受口服托吡酯(n = 36; Brijder Addiction Treatment,海牙),口服莫达非尼(n = 36; Arkin,Amsterdam)治疗12周,或口服右旋苯丙胺持续释放(n = 36; Bouman GGZ,鹿特丹)作为认知行为疗法(CBT)的附加药物,或仅接受12周的CBT(对照组:n = 3×36)。这些可行性试验的主要结果是保留了基本的心理社会治疗(CBT)。次要结果是对研究药物的接受程度和依从性,安全性,可卡因(和其他药物)使用的变化,身心健康,社会功能和患者满意度。讨论迄今为止,CATCH研究是荷兰的第一项研究,该研究探讨了针对戒除可卡因的新疗法,重点是节制和最小化伤害。预期该研究将有助于开发最有问题的物质使用障碍之一的新疗法。试验注册荷兰国家试验注册NTR2576欧盟药物管制局临床试验EudraCT2009-010584-16

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