Background: Methamphetamine use disorder is an important public health problem, especially in the younger generation, and associated with various psychiatric, cognitive, social, economic, and legal issues. Cabergoline, a drug with dopaminergic properties and long half-life, has been considered for the treatment of stimulant dependence. The systemic use of cabergoline has been shown to increase glial cell-derived neurotrophic factor (GDNF) expression. Objective: In this study, we investigated the effects of cabergoline on the serum level of GDNF and its effect on abstaining from methamphetamine in individuals treated for methamphetamine use disorder. Method: Sixty male subjects with methamphetamine use disorder were randomly assigned to 2 groups receiving cabergoline and placebo, respectively. During a 12-week follow-up, we compared the serum level of GDNF, urine test results for methamphetamine use, and depression scale between the 2 groups. Results: We found that serum GDNF was lower in subjects who used methamphetamine than healthy subjects (p #x3c; 0.0001). However, the serum level of GDNF was not associated with cabergoline use. The rising number of cases testing positive in the placebo group showed a trend resulting in no significant difference between cases testing positive and negative (p = 0.585) at the end of week 12. In the verum group, however, the significantly high number of cases who tested negative – sober – for substances observed in early stages (weeks 7–8) continued to remain significantly higher till the end of the study (p = 0.043), resembling an association between treatment with cabergoline and remaining sober. Although reduced during treatment, recovery from depression was not associated with cabergoline treatment. Conclusion: The findings of this study confirmed the effect of cabergoline in reducing methamphetamine use. However, a serum level of the GDNF increase, as seen in animal studies, was not associated with cabergoline treatment of human subjects. This study was registered at the Iranian Registry of Clinical Trials (TRN:IRCT2015050422077N1, October 06, 2015, https://en.irct.ir/trial/19134).
Eur Addict Res

中文翻译：

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卡麦角林治疗甲基苯丙胺依赖患者及其对血清胶质细胞源性神经营养因子水平的影响：一项随机、双盲、安慰剂对照的临床试验

背景：甲基苯丙胺使用障碍是一个重要的公共卫生问题，尤其是在年轻一代中，并与各种精神、认知、社会、经济和法律问题相关。卡麦角林是一种具有多巴胺能特性和长半衰期的药物，已被考虑用于治疗兴奋剂依赖。卡麦角林的全身使用已被证明可以增加神经胶质细胞衍生的神经营养因子 (GDNF) 的表达。目的：在本研究中，我们调查了卡麦角林对 GDNF 血清水平的影响及其对接受甲基苯丙胺使用障碍治疗的个体戒除甲基苯丙胺的影响。方法：60 名患有甲基苯丙胺使用障碍的男性受试者被随机分配到分别接受卡麦角林和安慰剂的 2 组。在 12 周的随访期间，我们比较了两组之间的血清 GDNF 水平、甲基苯丙胺使用的尿液检测结果和抑郁量表。结果：我们发现使用甲基苯丙胺的受试者的血清 GDNF 低于健康受试者 ( p #x3c; 0.0001)。然而，GDNF 的血清水平与卡麦角林的使用无关。安慰剂组中检测阳性的病例数呈上升趋势，导致检测阳性和阴性病例之间没有显着差异（p= 0.585) 在第 12 周结束时。然而，在 verum 组中，在早期（第 7-8 周）观察到的物质检测呈阴性 - 清醒 - 的病例数显着增加，直到结束该研究 ( p = 0.043)，类似于卡麦角林治疗与保持清醒之间的关联。尽管在治疗期间有所减轻，但抑郁症的恢复与卡麦角林治疗无关。结论：这项研究的结果证实了卡麦角林在减少甲基苯丙胺使用方面的作用。然而，正如在动物研究中所见，血清 GDNF 水平的升高与人类受试者的卡麦角林治疗无关。本研究已在伊朗临床试验注册处注册（TRN：IRCT2015050422077N1，2015 年 10 月 6 日，https://en.irct.ir/trial/19134）。
欧洲瘾君子研究