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

描述（由申请人提供）：本时间敏感申请的总体目标是测量奥施康定(R)的新滥用威慑制剂（ADF）在减少奥施康定(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地区。国家药物管制政策办公室（ONDCP）和FDA强烈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该药物治疗疼痛的有效性外，迄今为止还没有流行病学研究来检验adf是否确实有效地减少了任何药物的滥用。一项关于处方阿片类药物滥用的纵向流行病学研究目前正在肯塔基州农村地区（R01-DA024598）进行后期随访，其中94.8%的参与者在其一生中滥用奥施康定(R)， 81%的参与者在改变处方前6个月内滥用该药物。鉴于奥施康定(R)在配方改变前滥用的高流行率，本研究样本是检测奥施康定(R)新ADF滥用信号变化的理想选择。具体目的包括：1)评价ADF对奥施康定(R)减少口服、鼻内和注射途径滥用的有效性；2)确定一旦非adf版本不再在街上可用，阿片类药物使用者是否过渡到滥用其他处方阿片类药物；3)检查在旧配方不再可用后，由于给药途径的改变而导致的艾滋病毒和丙型肝炎（HCV）患病率和发病率的变化。鉴于adf在减少处方阿片类药物滥用方面的有效性缺乏流行病学数据，这项具有时间敏感性的研究具有重要意义。此外，该研究具有独特的定位，可以快速测量ADF对奥施康定(R)的有效性，并且不会产生如果回顾性评估滥用会导致的潜在偏差。鉴于ONDCP和FDA对处方阿片类药物adf的进一步开发的重视，本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ADF模型在多个公共卫生领域的有效性，包括该产品通过口服、鼻内和注射给药途径的滥用和误用的变化。反过来，这项研究的结果不仅将对公共卫生产生巨大影响，而且还将对围绕adf发展的政策产生巨大影响，以防止滥用处方阿片类药物。

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.