PHYSIOLOGICAL & BEHAVIORAL EFFECTS OF AMPHETAMINE AND COCAINE IN COMBINATION

本研究探讨了使用兴奋剂的安全性和可能的效用 可卡因使用者的替代疗法。 我们特别 正在研究可卡因和苯丙胺之间的药物相互作用 在可卡因使用人群中。 这是人类实验室第二阶段安全 与III期临床试验联合进行的研究 评估安非他明处方会减少 依赖性患者滥用可卡因。 男性和女性受试者 最近可卡因滥用史的人接受了两剂安非他明 （安慰剂或30 mg）作为两个剂量之一之前的一小时预处理， 可卡因（安慰剂或96 mg鼻内）。 因此，研究设计为 检查每种药物单独作用的安慰剂对照2x2析因 以及两者的结合。 然而，人类安全问题要求， 受试者首先接受每种药物单独给药，然后联合给药。 管理。 这项研究已接近完成，但数据尚未 被分析。 然而，重要的是我们的假设 没有临床上显著的副作用或改变， 心血管功能的发生表明，至少有中度 剂量的苯丙胺和可卡因可以安全地组合。 最终数据 关于苯丙胺是否改变滥用潜力的分析 可卡因的研究应在大约两个月内完成。

This study examines the safety and possible utility of using stimulant medications as substitution therapy in cocaine users. Specifically, we are examining the drug interactions between cocaine and dextroamphetamine in a cocaine-using population. This is a Human Laboratory Phase II safety study being conducted in conjunction with Phase III Clinical Trials evaluating the hypothesis that dextroamphetamine prescription will reduce the abuse of cocaine in dependent patients. Male and female subjects with histories of recent cocaine abuse receive two doses of dextroamphetamine (placebo or 30 mg) as a one-hour pretreatment before one of two doses of cocaine (placebo or 96 mg intranasal). Therefore, the study design was a placebo-controlled 2x2 factorial examining the effects of each drug alone and the two in combination. However, human safety issues required that subjects receive each drug alone first, before the combination was administered. The study is nearly completed but the data have not yet been analyzed. However, important to the hypothesis has been our experience that no clinically significant side effects or alterations in cardiovascular functioning have occurred suggesting that at least moderate doses of dextroamphetamine and cocaine can be safely combined. Final data analysis examining whether dextroamphetamine altered the abuse potential of cocaine should proceed at study completion in approximately two months.