NAOMI: The trials and tribulations of implementing a heroin assisted treatment study in North America
NAOMI: The trials and tribulations of implementing a heroin assisted treatment study in North America
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DOI：
10.1186/1477-7517-6-2
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发表时间：
2009-01-21
影响因子：
4.4
通讯作者：
Schechter, Martin T.
中科院分区：
文献类型：
--
作者：
Gartry, Candice C.;Oviedo-Joekes, Eugenia;Schechter, Martin T.
背景：阿片成瘾是一种慢性、复发性疾病，仍然是一项重大的公共卫生挑战。尽管获得常规治疗的机会有了重要的扩大，但仍然有相当大比例的受影响个人仍然处于当前治疗系统的覆盖范围之外，他们对医疗保健和刑事司法费用以及与吸毒成瘾有关的公共疾病做出了不成比例的贡献。NAOMI研究是一项第三阶段随机临床试验，比较了注射海洛因维持和口服美沙酮。这项研究在蒙特利尔和温哥华获得了伦理委员会的批准，并得到了多伦多大学、纽约医学院和约翰·霍普金斯大学的批准。NAOMI研究的主要目的是确定在招募、保留和受益于对当前标准治疗方案产生抵抗的慢性阿片依赖注射吸毒者方面，密切监督的可注射药物级阿片激动剂是否比单独使用美沙酮更有效。方法：提交的案例研究记录了在北美启动并运行海洛因辅助治疗试验的挑战。它描述了：关于阿片成瘾的简要背景；目前阿片成瘾的标准治疗方法；为什么需要海洛因辅助治疗试验；海洛因辅助治疗的描述；在北美创建Naomi研究的开始；Naomi研究的科学和政治；在加拿大启动Naomi研究；启动和运行研究的各种要求和限制；招募参与研究；与媒体合作；研究的现状报告；以及作者观点的简要结论。结果和结论：由于这是一项个案研究，没有具体结果或主要发现列出。案例研究的重点是：研究的背景；在加拿大启动研究的条件；获得场地和研究获得批准的独特要求和条件；与媒体的合作；研究的招募；研究的简要现状报告；以及作者观点的简要结论。
Background: Opioid addiction is a chronic, relapsing disease and remains a major public health challenge. Despite important expansions of access to conventional treatments, there are still significant proportions of affected individuals who remain outside the reach of the current treatment system and who contribute disproportionately to health care and criminal justice costs as well as to public disorder associated with drug addiction.The NAOMI study is a Phase III randomized clinical trial comparing injectable heroin maintenance to oral methadone. The study has ethics board approval at its Montreal and Vancouver sites, as well as from the University of Toronto, the New York Academy of Medicine and Johns Hopkins University.The main objective of the NAOMI Study is to determine whether the closely supervised provision of injectable, pharmaceutical-grade opioid agonist is more effective than methadone alone in recruiting, retaining, and benefiting chronic, opioid-dependent, injection drug users who are resistant to current standard treatment options.Methods: The case study submitted chronicles the challenges of getting a heroin assisted treatment trial up and running in North America. It describes: a brief background on opioid addiction; current standard therapies for opioid addiction; why there is/was a need for a heroin assisted treatment trial; a description of heroin assisted treatment; the beginnings of creating the NAOMI study in North America; what is the NAOMI study; the science and politics of the NAOMI study; getting NAOMI started in Canada; various requirements and restrictions in getting the study up and running; recruitment into the study; working with the media; a status report on the study; and a brief conclusion from the authors' perspectives.Results and conclusion: As this is a case study, there are no specific results or main findings listed. The case study focuses on: the background of the study; what it took to get the study started in Canada; the unique requirements and conditions of getting a site, and the study, approved; working with the media; recruitment into the study; a brief status report on the study; and a brief conclusion from the authors' perspectives.