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A single-day paradigm of self-regulated human cocaine administration

机译：自我调节人类可卡因管理的单日范例

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Prior work by our group has shown the feasibility, safety, and validity of a multi-day, multi-dose paradigm of self-regulated cocaine administration in humans. The current work sought to consolidate these methods in a single-day design focused on reducing logistical complexity, decreasing research burden to human subjects, and increasing suitability for medication development designs. Methods: Eleven experienced cocaine users participated in a 6-hour, single-day design, consisting of one safety/eligibility and three experimental cocaine periods (during which subjects were allowed to self-administer 8, 16, and 32 mg/70 kg cocaine doses under a fixed-ratio 1:5 minute timeout schedule). Changes in cocaine-induced cardiovascular response, self-administration behavior, and subjective effects were assessed. Results: Procedures were well tolerated by participants, and no significant adverse events were noted. Significant (p < 0.05), changes in measures of cocaine self-administration (e.g., responses, infusions, interinfusion intervals, consumption, and plasma levels), cardiovascular response (HR), and subjective effects (high) were observed. In contrast, cocaine-induced increases in other vital signs (e.g., SBP, DBP) and subjective effect measures (e.g., paranoia) did not differ between doses. Conclusions: These data support the safety, tolerability and validity of our single-day design. Depending on the application, such methods may afford advantages for assessing the self-regulation of cocaine administration behavior in humans (e.g., including medication development designs).
机译：我们小组的先前工作显示了在人体内自我调节可卡因的多天，多剂量范例的可行性，安全性和有效性。当前的工作试图将这些方法整合到单日设计中，重点是降低后勤复杂性，减轻人类受试者的研究负担以及提高对药物开发设计的适用性。方法：11名经验丰富的可卡因使用者参加了为期6小时，单日的设计，包括一个安全性/资格和三个实验可卡因时期（在此期间，受试者可以自行管理8、16和32 mg / 70 kg可卡因）在固定比例的1：5分钟超时时间表下服用）。评估可卡因诱导的心血管反应，自我给药行为和主观效应的变化。结果：参与者对手术的耐受性良好，未发现明显的不良事件。观察到显着（p <0.05），可卡因自我给药量度的变化（例如反应，输注，输注间隔，消耗量和血浆水平），心血管反应（HR）和主观效果（高）。相反，可卡因诱导的其他生命体征（例如SBP，DBP）的增加和主观效果量度（例如妄想症）在剂量之间没有差异。结论：这些数据支持我们单日设计的安全性，耐受性和有效性。取决于应用，这样的方法可以提供用于评估人中可卡因施用行为的自我调节的优势（例如，包括药物开发设计）。

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