PHYSIOLOGICAL & BEHAVIORAL EFFECTS OF AMPHETAMINE AND COCAINE IN COMBINATION

本研究探讨了使用兴奋剂药物作为可卡因使用者替代治疗的安全性和可能的效用。 具体来说，我们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。 这是一项人体实验室II期安全性研究，正在与III期临床试验联合进行，以评估苯丙胺处方将减少依赖患者滥用可卡因的假设。 有近期可卡因滥用史的男性和女性受试者在两剂可卡因（安慰剂或96 mg鼻内）之一之前接受两剂苯丙胺（安慰剂或30 mg）作为1小时预处理。 因此，研究设计为安慰剂对照2x2析因，检查每种药物单独使用和两种药物联合使用的效果。 然而，人体安全性问题要求受试者在联合给药前首先单独接受每种药物。 这项研究已接近完成，但数据尚未分析。 然而，重要的假设是我们的经验，没有临床上显着的副作用或心血管功能的改变已经发生，这表明至少中等剂量的苯丙胺和可卡因可以安全地组合。 在研究完成后大约两个月内，应进行最后数据分析，以确定苯丙胺是否改变可卡因的滥用潜力。

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.