Schmitz Joy M, Rathnayaka Nuvan, Green Charles E, Moeller F Gerard, Dougherty Anne E, Grabowski John
Department of Psychiatry and Behavioral Sciences, University of Texas Houston, TX, USA.
Front Psychiatry. 2012 Aug 30;3:77. doi: 10.3389/fpsyt.2012.00077. eCollection 2012.
Two stimulant medications, modafinil and d-amphetamine, when tested individually, have shown safety and efficacy for treatment of cocaine addiction. We hypothesized that the combination of modafinil and d-amphetamine, at low doses, would show equivalent or greater benefit in reducing cocaine use compared to higher doses of each individual medication or placebo.
Sixteen week, randomized, parallel-group design with four treatment arms comparing placebo to modafinil 400 mg; d-amphetamine 60 mg; modafinil 200 mg plus d-amphetamine 30 mg. Primary outcome variables, retention and cocaine use, were analyzed on the sample of 73 participants who received the first dose of the study medication.
Retention rates did not differ between groups and were generally low, with 40% remaining in treatment at week 12 and 20% at week 16. Participants receiving the combination of modafinil and d-amphetamine showed a trend of increased cocaine use over time with a corresponding low Bayesian probability of benefit (33%). Relatively better cocaine outcomes were observed in the placebo and d-amphetamine only groups. The study medications were generally well-tolerated with few adverse effects, yet rates of adherence were suboptimal (≤80%).
Data from this preliminary investigation fail to provide evidential support for conducting a larger study of this dual-agonist medication combination for treatment of cocaine dependence.
两种兴奋剂药物，莫达非尼和右旋苯丙胺，单独测试时已显示出治疗可卡因成瘾的安全性和有效性。我们假设，与高剂量的每种单一药物或安慰剂相比，低剂量的莫达非尼和右旋苯丙胺联合使用在减少可卡因使用方面将显示出同等或更大的益处。
采用为期16周的随机平行组设计，有四个治疗组，将安慰剂与400毫克莫达非尼、60毫克右旋苯丙胺、200毫克莫达非尼加30毫克右旋苯丙胺进行比较。对接受研究药物首剂的73名参与者的样本分析了主要结局变量，即留存率和可卡因使用情况。
各组之间的留存率没有差异，且总体较低，12周时40%的人仍在接受治疗，16周时为20%。接受莫达非尼和右旋苯丙胺联合治疗的参与者随着时间的推移显示出可卡因使用增加的趋势，相应的获益贝叶斯概率较低（33%）。在仅使用安慰剂和右旋苯丙胺的组中观察到相对较好的可卡因治疗效果。研究药物总体耐受性良好，不良反应较少，但依从率不理想（≤80%）。
这项初步调查的数据未能为开展更大规模的关于这种双激动剂药物组合治疗可卡因依赖的研究提供证据支持。
