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Evaluating the abuse potential of psychedelic drugs as part of the safety pharmacology assessment for medical use in humans

机译：评估迷幻药物的滥用潜力，作为人类医疗用药的一部分

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Psychedelics comprise drugs come from various pharmacological classes including 5-HT2A agonists, indirect 5-HT agonists, e.g., MDMA, NMDA antagonists and K-opioid receptor agonists. There is resurgence in developing psychedelics to treat psychiatric disorders with high unmet clinical need. Many, but not all, psychedelics are schedule 1 controlled drugs (CDs), i.e., no approved medical use. For existing psychedelics in development, regulatory approval will require a move from schedule 1 to a CD schedule for drugs with medical use, i.e., schedules 2-5. Although abuse of the psychedelics is well documented, a systematic preclinical and clinical evaluation of the risks they pose in a medical-use setting does not exist. We describe the non-clinical tests required for a regulatory evaluation of abuse/dependence risks, i.e., drug-discrimination, intravenous self-administration and physical dependence liability. A synopsis of the existing data for the various types of psychedelics is provided and we describe our findings with psychedelic drugs in these models. FDA recently issued its guidance on abuse/dependence evaluation of drug-candidates (CDER/FDA, 2017). We critically review the guidance, discuss the impact this document will have on non clinical abuse/dependence testing, and offer advice on how non-clinical abuse/dependence experiments can be designed to meet not only the expectations of FDA, but also other regulatory agencies. Finally, we offer views on how these non-clinical tests can be refined to provide more meaningful information to aid the assessment of the risks posed by CNS drug-candidates for abuse and physical dependence.
机译：迷幻术包含药物来自各种药理类别，包括5-HT2A激动剂，间接5-HT激动剂，例如MDMA，NMDA拮抗剂和K-阿片受体激动剂。发展迷幻学治疗精神病患者具有高未满足临床需求的精神疾病。许多人，但不是全部，迷幻学时间是第1安排1个受控药物（CDS），即，没有批准的医疗用途。对于现有的开发迷幻学，监管批准将需要从附表1向涉及医疗使用的药物的CD时间表，即时间表2-5。虽然滥用迷幻学被妥善记录，但对医疗使用环境中的风险进行了系统的临床前和临床评价，并不存在。我们描述了对滥用/依赖风险的监管评估所需的非临床试验，即药物歧视，静脉内自我管理和物理依赖责任。提供了各种迷幻学的现有数据的概要，并在这些模型中使用荧光药物描述了我们的研究结果。 FDA最近发布了对毒品 - 候选人的滥用/依赖评估的指导（CDE / FDA，2017）。我们批判地审查了指导，讨论了本文件对非临床滥用/依赖性测试的影响，并提供有关非临床滥用/依赖实验的咨询，不仅可以旨在满足FDA的期望，还可以旨在满足FDA的期望，还能提供其他监管机构的期望。最后，我们提供了关于如何精制这些非临床测试的意见，以提供更有意义的信息，以帮助评估CNS药物 - 候选人滥用和物理依赖的风险。

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