Evaluating the potential impact of a reformulated version of oxycodone upon tampering, non-adherence and diversion of opioids: the National Opioid Medications Abuse Deterrence (NOMAD) study protocol
Evaluating the potential impact of a reformulated version of oxycodone upon tampering, non-adherence and diversion of opioids: the National Opioid Medications Abuse Deterrence (NOMAD) study protocol
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DOI：
10.1111/add.12746
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发表时间：
2015-02-01
期刊：
影响因子：
6
通讯作者：
Farrell, Michael
中科院分区：
文献类型：
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作者：
Degenhardt, Louisa;Larance, Briony;Farrell, Michael
目的2014年初，一种新的羟考酮制剂（新配方奥施康定（（R）在澳大利亚上市。它是作为药物的防篡改（滥用威慑）配方开发的。我们总结了国家阿片类药物滥用威慑（NOMAD）研究中使用的方法，该研究将检查：（i）是否减少了医疗外使用（包括通过篡改）引入改良奥施康定（（R））后的奥施康定（（R））;（ii）非滥用威慑形式的羟考酮、其他药用阿片类药物和非法药物的医疗外使用的潜在变化;（iii）随着时间的推移，篡改新配方奥施康定（R）的方法是否变得普遍;（iv）新配方奥施康定（R）在非法市场上的吸引力;以及（v）与奥施康定（R）和其他药物有关的销售、处方和危害。首先，分析现有的常规数据来源，如：药品销售;处方数据;药物过量死亡数据;关于一般人群和注射吸毒者中药物使用情况的调查数据;其次，通过非法药物报告系统收集的关于奥施康定（R）的具体数据;第三，在引入改良奥施康定（R）之前，形成了一个前瞻性队列，其中n=606人经常滥用或篡改药物阿片类药物，随访两次后释放，以检查潜在的变化后，重新奥施康定（（R））的introduction.DiscussionThe研究的优势在于不同的数据收集;中断的时间序列分析;和前瞻性队列。据我们所知，这是迄今为止对阿片类药物在使用、篡改和转移后的潜在影响进行的最全面、最透明的研究之一。研究结果有可能为政策制定者、临床医生、消费者和研究人员提供信息。
AimsA new oxycodone formulation (Reformulated OxyContin((R))) was released in Australia, early 2014. It was developed as a tamper-resistant (abuse-deterrent') formulation of the drug. We summarize methods used in the National Opioid Medication Abuse Deterrence (NOMAD) study, which will examine: (i) whether there is a reduction in extra-medical use (including via tampering) of OxyContin((R)) following the introduction of Reformulated OxyContin((R)); (ii) potential changes in extra-medical use of non-abuse-deterrent forms of oxycodone, other pharmaceutical opioids and illicit drugs; (iii) whether methods of tampering with Reformulated OxyContin((R)) become widespread over time; (iv) Reformulated OxyContin((R))'s attractiveness on the illicit market; and (v) sales, prescriptions and harms related to OxyContin((R)) and other drugs.MethodsThere are three major components. First, analyses of existing routine data sources such as: pharmaceutical sales; prescribing data; data on drug overdose deaths; and survey data on drug use in the general population and among people who inject drugs; secondly, specific data on OxyContin((R)) collected through the Illicit Drug Reporting System; and thirdly, a prospective cohort of n=606 people who regularly misuse or tamper with pharmaceutical opioids was formed prior to the introduction of Reformulated OxyContin((R)), followed-up twice post-release to examine potential changes after Reformulated OxyContin((R))'s introduction.DiscussionThe study's strengths lie in varied data collections; interrupted time-series analysis; and prospective cohort. To our knowledge, this is one of the most comprehensive and transparently conducted studies conducted to date of the potential impact of an opioid medication upon use, tampering and diversion. Results have the potential to inform policymakers, clinicians, consumers and researchers alike.