Cocaine use disorder is a persistent public health problem for which no widely effective medications exist. Self-administration procedures, which have shown good predictive validity in estimating the abuse potential of drugs, have been used in rodent, nonhuman primate, and human laboratory studies to screen putative medications. This review assessed the effectiveness of the medications development process regarding pharmacotherapies for cocaine use disorder. The primary objective was to determine whether data from animal and human laboratory self-administration studies predicted the results of clinical trials. In addition, the concordance between laboratory studies in animals and humans was assessed. More than 100 blinded, randomized, fully placebo-controlled studies of putative medications for cocaine use disorder were identified. Of the 64 drugs tested in these trials, only 10 had been examined in both human and well-controlled animal laboratory studies. Within all three stages, few studies had been conducted for each drug and when multiple studies had been conducted conclusions were sometimes contradictory. Overall, however, there was good concordance between animal and human laboratory results when the former assessed chronic drug treatment. Although only seven of the ten reviewed drugs showed fully concordant results across all three types of studies reviewed, the analysis revealed several subject-related, procedural, and environmental factors that differ between the laboratory and clinical trial settings that help explain the disagreement for other drugs. The review closes with several recommendations to enhance translation and communication across stages of the medications development process that will ultimately speed the progress toward effective pharmacotherapeutic strategies for cocaine use disorder.

中文翻译：

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可卡因使用障碍药物开发中的“管道”评估：转化前临床前，人体实验室和临床试验研究的回顾。

可卡因使用障碍是一个持续存在的公共卫生问题，目前尚无广泛有效的药物。在啮齿动物，非人类灵长类动物和人体实验室研究中，自我管理程序在估计药物滥用潜力方面显示出良好的预测效度，已被用于筛选推定的药物。这篇综述评估了关于可卡因使用障碍的药物治疗药物开发过程的有效性。主要目的是确定来自动物和人类实验室自我管理研究的数据是否能预测临床试验的结果。此外，还评估了动物和人类实验室研究之间的一致性。查明了可卡因使用障碍的假定药物的100多项盲法，随机，完全安慰剂对照研究。在这些试验中测试的64种药物中，只有10种在人体实验和对照良好的动物实验室研究中均进行了检查。在这三个阶段中，针对每种药物进行的研究很少，而当进行多次研究时，结论有时是矛盾的。总体而言，当前者评估慢性药物治疗时，动物和人类实验室结果之间存在良好的一致性。尽管在所审查的所有三种研究中，十种被审查药物中只有七种显示出完全一致的结果，但分析显示，与实验室和临床试验设置不同的几种与受试者相关的，程序上和环境上的因素也有所不同，这有助于解释对其他药物的分歧。