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首页> 美国卫生研究院文献>Pain Medicine: The Official Journal of the American Academy of Pain Medicine >Abuse Potential with Oral Route of Administration of a Hydrocodone Extended-Release Tablet Formulated with Abuse-Deterrence Technology in Nondependent Recreational Opioid Users
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Abuse Potential with Oral Route of Administration of a Hydrocodone Extended-Release Tablet Formulated with Abuse-Deterrence Technology in Nondependent Recreational Opioid Users

机译：在非依赖性休闲性阿片类药物使用者中采用滥用抑制技术配制的氢可酮缓释片的口服途径具有滥用潜力

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>Objective. To compare the oral abuse potential of hydrocodone extended-release (ER) tablet developed with CIMA® Abuse-Deterrence Technology with that of hydrocodone immediate release (IR).>Design. Randomized, double-blind, placebo-controlled, crossover study.>Setting and Patients. One study site in the United States; adult nondependent, recreational opioid users.>Methods. After confirming their ability to tolerate and discriminate hydrocodone IR 45 mg from placebo, eligible participants were randomized to receive each of the following oral treatments once: finely crushed placebo, hydrocodone IR 45-mg powder, intact hydrocodone ER 45-mg tablet, and finely crushed hydrocodone ER 45-mg tablet. Primary pharmacodynamic measure was “at the moment” drug liking. Secondary measures included overall drug liking, drug effects (e.g., balance, positive, negative, sedative), pupillometry, pharmacokinetics, and safety.>Results. Mean maximum effect (Emax) for “at the moment” drug liking was significantly lower for intact (53.9) and finely crushed hydrocodone ER (66.9) vs. hydrocodone IR (85.2; P < 0.001). Drug liking for intact hydrocodone ER was comparable to placebo (Emax: 53.9 vs. 53.2). Secondary measures were consistent with these results, indicating that positive, negative, and sedative drug effects were diminished with intact and crushed hydrocodone ER tablet vs. hydrocodone IR. The 72-hour plasma concentration-time profile for each treatment mimicked its respective “at the moment” drug-liking-over-time profile. Incidence of adverse events was lower with intact hydrocodone ER (53%) vs. hydrocodone IR (79%) and finely crushed hydrocodone ER (73%).>Conclusions. The oral abuse potential of hydrocodone ER (intact and finely crushed) was significantly lower than hydrocodone IR in healthy, nondependent, recreational opioid users. Hydrocodone ER was generally well tolerated.
机译：>目标。比较使用CIMA ®滥用预防技术开发的氢可酮缓释（ER）片剂与氢可酮立即释放（IR）的口服滥用潜力。>设计。 ，双盲，安慰剂对照，交叉研究。>背景和患者。美国的一个研究中心；成人非依赖性，休闲性阿片类药物使用者。>方法。在确认他们能够耐受和区分安慰剂中氢可酮IR 45mg的能力后，将符合条件的参与者随机接受一次以下口服治疗：细碎的安慰剂，氢可酮IR 45毫克粉末，完整的氢可酮ER 45毫克片剂和细碎的氢可酮ER 45毫克片剂。主要药效学指标是“目前”喜欢的药物。次要指标包括总体药物喜欢程度，药物作用（例如，平衡，阳性，阴性，镇静作用），瞳孔测定，药代动力学和安全性。>结果。“目前”药物的平均最大作用（Emax）完整（53.9）和细碎的氢可酮ER（66.9）的喜好明显低于氢可酮IR（85.2; P <0.001）。喜欢完整氢可酮ER的药物与安慰剂相当（Emax：53.9与53.2）。次级措施与这些结果一致，表明与氢可酮IR相比，完整和压碎的氢可酮ER片剂可降低阳性，阴性和镇静药物的作用。每种治疗的72小时血浆浓度-时间曲线类似于其各自的“当前”随时间推移的药物喜欢曲线。完整的氢可酮ER（53％）相对于氢可酮IR（79％）和细碎的氢可酮ER（73％）的不良事件发生率更低。>结论。氢可酮ER的口服滥用潜力（完整健康的，非依赖性的，娱乐性的阿片类药物使用者，其含量大大低于氢可酮IR。氢可酮ER一般耐受良好。

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