BACKGROUND:Amphetamine analogs have been demonstrated to have some efficacy in reducing use in cocaine dependent individuals. However, these agents also have potential for abuse. Lisdexamfetamine (LDX), a lysine+dextroamphetamine formulation, has been approved for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) and as a prodrug, has less abuse potential.
OBJECTIVE:This pilot study sought to evaluate the safety, tolerability, and efficacy of LDX as a candidate treatment for cocaine dependence.
METHODS:A randomized, double-blind, placebo-controlled parallel group study served to evaluate LDX in 43 cocaine-dependent individuals: (1) placebo (PBO; 0mg, n=21), (2) LDX (70mg, n=22). Participants received medication for 14 weeks. Cocaine use was determined based on urine analysis for benzoylecgonine (BE; a cocaine metabolite).
RESULTS:Retention rates were higher though not significantly different in the PBO (71.4%) than the LDX condition (57.1%). Compared to those in the PBO condition, those receiving LDX were more likely to report experiencing (ps<0.05) diarrhea (45.5% vs. 14.3%), headaches (45.5% vs. 9.5%), and anxiety (31.8% vs. 4.8%). No differences in medication conditions were observed for blood pressure, heart rate, or body weight. In the randomized sample, no differences in cocaine use were seen. Those receiving LDX reported significantly less craving for cocaine than participants receiving PBO.
CONCLUSIONS:LDX did not significantly reduce cocaine use compared to PBO in the randomized sample.
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【Pilot study of the effects of lisdexamfetamine on cocaine use: A randomized, double-blind, placebo-controlled trial.].
【赖氨苯丙胺对可卡因使用的影响的试验研究：一项随机，双盲，安慰剂对照的试验。】
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DOI：10.1016/j.drugalcdep.2015.05.042文章类型：杂志文章
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背景：苯丙胺类似物已被证明在减少可卡因依赖者的使用方面具有一定功效。但是，这些代理也有可能被滥用。赖氨酸右苯丙胺制剂Lisdexamfetamine（LDX）已被批准用于治疗注意力缺陷/多动症（ADHD），并且作为前药，滥用潜力较小。
目的：本试验研究旨在评估LDX作为可卡因依赖治疗的候选药物的安全性，耐受性和疗效。
方法：一项随机，双盲，安慰剂对照的平行组研究用于评估43位可卡因依赖者的LDX：（1）安慰剂（PBO; 0mg，n = 21），（2）LDX（70mg，n = 22） ）。参与者接受了14周的药物治疗。根据尿液中苯甲酰芽子碱（BE；可卡因代谢物）的分析确定可卡因的使用。
结果：PBO的保留率更高（71.4％），与LDX的保留率（57.1％）没有显着差异。与PBO情况相比，接受LDX的人更容易出现腹泻（ps <0.05）（45.5％比14.3％），头痛（45.5％比9.5％）和焦虑症（31.8％比4.8）。 ％）。血压，心率或体重在用药条件上未见差异。在随机样本中，可卡因的使用没有差异。与接受PBO的参与者相比，接受LDX的人对可卡因的渴望显着减少。
结论：与PBO相比，随机样本中LDX并未显着减少可卡因的使用。
目的：本试验研究旨在评估LDX作为可卡因依赖治疗的候选药物的安全性，耐受性和疗效。
方法：一项随机，双盲，安慰剂对照的平行组研究用于评估43位可卡因依赖者的LDX：（1）安慰剂（PBO; 0mg，n = 21），（2）LDX（70mg，n = 22） ）。参与者接受了14周的药物治疗。根据尿液中苯甲酰芽子碱（BE；可卡因代谢物）的分析确定可卡因的使用。
结果：PBO的保留率更高（71.4％），与LDX的保留率（57.1％）没有显着差异。与PBO情况相比，接受LDX的人更容易出现腹泻（ps <0.05）（45.5％比14.3％），头痛（45.5％比9.5％）和焦虑症（31.8％比4.8）。 ％）。血压，心率或体重在用药条件上未见差异。在随机样本中，可卡因的使用没有差异。与接受PBO的参与者相比，接受LDX的人对可卡因的渴望显着减少。
结论：与PBO相比，随机样本中LDX并未显着减少可卡因的使用。
