Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, 5510 Nathan Shock Drive, Baltimore, MD 21224, USA; Ashley Addiction Treatment, 800 Tydings Ln, Havre De Grace, MD 21078, USA.
Department of Behavioral Science, University of Kentucky College of Medicine, 1100 Veterans Drive, Medical Behavioral Science Building Room 140, Lexington, KY 40536, USA.
Int J Drug Policy. 2022 Aug;106:103751. doi: 10.1016/j.drugpo.2022.103751. Epub 2022 May 26.
Higher-dose formulations of naloxone were recently approved by the FDA for the treatment of opioid overdose. These products were developed based on projected saturation of high-potency fentanyl analogues in the illicit marketplace although the evidence base for their necessity is still under scrutiny. Concern has been raised that unintended reductions in patient acceptance of naloxone may occur due to increased precipitated withdrawal risk associated with higher naloxone doses. A well-founded and time-sensitive call for representation of people who use drugs in this decision-making process has been made. This study provides the first data on patient perceptions of higher-dose formulations to inform this scientific debate and distribution efforts.
Patients (N=1152) entering treatment for opioid use disorder at one of 49 addiction treatment facilities located across the United States completed a preference assessment of naloxone nasal spray formulations. Patients selected a formulation preference across three scenarios (administration for self, administration to others, community responder administration).
A majority of respondents that had been administered naloxone previously reported that their most recent overdose reversal included two or more naloxone administrations (59.9%). Most respondents either had no preference (48.4%) or preferred a higher-dose formulation (35.9%) if personally experiencing an overdose. Similar preference distributions were observed for administration to others and by community responders. Relative to standard-dose preference, respondents preferring higher-dose formulations had a greater odds of recent suspected fentanyl exposure.
These data inform patients, advocates, and policy-makers considering distribution and utilization of naloxone formulations by reporting perspectives of patients with opioid use and overdose experience. Limited evidence for widespread avoidance of higher-dose formulations was found. As real-world evidence of acceptability and effectiveness emerges, either supporting or refuting the widespread need for higher-dose naloxone formulations, it is the responsibility of the scientific and public health community to be responsive to those data.
最近，美国食品和药物管理局（FDA）批准了更高剂量的纳洛酮制剂，用于治疗阿片类药物过量。这些产品是基于预计在非法市场上高浓度芬太尼类似物饱和的基础上开发的，尽管它们是否有必要的证据基础仍在审查中。人们担心，由于与更高剂量纳洛酮相关的戒断风险增加，患者对纳洛酮的接受度可能会意外降低。有人强烈呼吁让使用毒品的人参与这一决策过程。这项研究提供了关于患者对更高剂量制剂的看法的第一批数据，以告知这一科学辩论和分配工作。
在美国 49 个成瘾治疗中心中的 49 个中心接受阿片类药物使用障碍治疗的患者（N=1152）完成了对纳洛酮鼻喷雾剂制剂的偏好评估。患者在三种情况下选择了一种制剂偏好（自我给药、他人给药、社区 responder 给药）。
大多数有过纳洛酮给药经历的受访者报告说，他们最近的药物过量逆转包括两次或更多次纳洛酮给药（59.9%）。如果个人经历过药物过量，大多数受访者要么没有偏好（48.4%），要么更喜欢更高剂量的制剂（35.9%）。对于他人给药和社区 responder 给药，也观察到类似的偏好分布。与标准剂量偏好相比，更喜欢更高剂量制剂的受访者最近疑似接触芬太尼的可能性更大。
这些数据为考虑分配和使用纳洛酮制剂的患者、倡导者和政策制定者提供了信息，报告了有阿片类药物使用和药物过量经历的患者的观点。研究发现，对更高剂量制剂的广泛回避的证据有限。随着现实世界中可接受性和有效性的证据出现，无论是支持还是反驳对更高剂量纳洛酮制剂的广泛需求，科学界和公共卫生界都有责任对这些数据做出回应。
