Epidemiologic Study of the Effectiveness of an ADF in Reducing Opioid Abuse

描述(由申请人提供)：这一时间敏感的申请的首要目标是衡量用于OxyContin(R)的新的滥用威慑配方(ADF)在减少OxyContin(R)滥用方面的有效性。处方阿片类药物滥用是一个主要的公共卫生问题，尤其困扰着美国农村。国家药物管制政策办公室(ONDCP)和FDA大力鼓励制药业开发防止滥用的配方；然而，除了在疼痛患者中进行的临床试验证明了该药物治疗疼痛的有效性外，到目前为止还没有流行病学研究检验ADF是否确实有效地减少了任何药物的滥用。在肯塔基州农村地区(R01-DA024598)，一项关于处方阿片类药物滥用的纵向流行病学研究目前处于后续阶段，其中94.8%的参与者在一生中滥用OxyContin(R)，81%的参与者在配方改变前的6个月内滥用该药物。考虑到在配方改变之前OxyContin(R)滥用的高流行率，这项研究样本是通过用于OxyContin(R)的新ADF来检测滥用信号变化的理想选择。具体目标包括：1)评估OxyContin(R)的ADF在减少口服、鼻腔和注射途径滥用方面的有效性；2)确定阿片类药物使用者是否在非ADF版本不再在街头销售时过渡到滥用其他处方阿片类药物；以及3)检查由于旧配方不再提供后给药途径的改变而导致的艾滋病毒和丙型肝炎(丙型肝炎)流行率和发病率的变化。考虑到缺乏与ADF在减少处方阿片类药物滥用方面的有效性相关的流行病学数据，这项时间敏感的研究具有非常重要的意义。此外，这项研究具有独特的地位，可以快速地衡量OxyContin(R)的ADF的有效性，而不会出现如果对滥用情况进行追溯评估将导致的潜在偏见。鉴于ONDCP和FDA对进一步开发用于处方阿片类药物的ADF的重要性，这项研究的结果除了对公共卫生外，还对公共政策具有广泛的影响。这项高度相关的研究将评估模型ADF在多个公共卫生领域的有效性，包括通过口服、鼻腔和注射给药途径改变该产品的滥用和误用。反过来，这项研究的结果不仅将对公共卫生产生巨大影响，还将对麻生太郎围绕ADF开发的政策产生巨大影响，以防止处方阿片类药物的滥用。

DESCRIPTION (provided by applicant): The overarching goal of this time-sensitive application is to measure the effectiveness of the new abuse deterrent formulation (ADF) for OxyContin(R) in decreasing abuse of OxyContin(R). Prescription opioid abuse is a major public health concern and has plagued the rural United States in particular. The Office of National Drug Control Policy (ONDCP) and the FDA have strongly encouraged the pharmaceutical industry to develop formulations that protect against abuse; however, apart from clinical trials among pain patients demonstrating efficacy of the drug for treating pain, there have been no epidemiologic studies to date that have examined whether ADFs are actually effective in reducing abuse of any drug. A longitudinal epidemiologic study of prescription opioid abuse is currently in the latter phase of follow-up in rural Kentucky (R01-DA024598) in which 94.8% of participants abused OxyContin(R) in their lifetime, and 81% abused the drug in the 6-months prior to the formulation change. Given this high prevalence of OxyContin(R) abuse before the formulation change, this study sample is ideal for detecting changes in signals of abuse with the new ADF for OxyContin(R). The specific aims include: 1) evaluation of the effectiveness of the ADF for OxyContin(R) in reducing abuse via oral, intranasal and injection routes; 2) determining whether opioid users transitioned to abuse of other prescription opioids once the non-ADF version was no longer available on the street; and 3) examination of changes in prevalence and incidence of HIV and hepatitis C (HCV) as a result of changes in route of administration after the old formulation was no longer available. This time-sensitive study is highly significant given the paucity of epidemiologic data related to the effectiveness of ADFs in reducing abuse of prescription opioids. Further, this study is uniquely positioned to measure the effectiveness of the ADF for OxyContin(R) expeditiously and without the potential bias that would result if abuse were assessed retrospectively. Given the importance that the ONDCP and the FDA have placed on further development of ADFs for prescription opioids, the results from this study have vast implications for public policy in addition to public health. This highly relevant study will evaluae the effectiveness of a model ADF across multiple public health domains, including changes in this product's abuse and misuse via the oral, intranasal and injection routes of administration. The results from this study, in turn, will have vast implications for not only public health, but aso policies surrounding development of ADFs in order to prevent abuse of prescription opioids.