National Institute on Drug Abuse, National Institutes of Health, Bethesda, MD 20892, USA.
Addiction. 2012 Jul;107(7):1297-306. doi: 10.1111/j.1360-0443.2011.03771.x. Epub 2012 Feb 28.
Topiramate has shown efficacy at facilitating abstinence from alcohol and cocaine abuse. This double-blind, placebo-controlled out-patient trial tested topiramate for treating methamphetamine addiction.
Participants (n = 140) were randomized to receive topiramate or placebo (13 weeks) in escalating doses from 25 mg/day [DOSAGE ERROR CORRECTED] to the target maintenance of 200 mg/day in weeks 6-12 (tapered in week 13). Medication was combined with weekly brief behavioral compliance enhancement treatment.
The trial was conducted at eight medical centers in the United States.
One hundred and forty methamphetamine-dependent adults took part in the trial.
The primary outcome was abstinence from methamphetamine during weeks 6-12. Secondary outcomes included use reduction versus baseline, as well as psychosocial variables.
In the intent-to-treat analysis, topiramate did not increase abstinence from methamphetamine during weeks 6-12. For secondary outcomes, topiramate reduced weekly median urine methamphetamine levels and observer-rated severity of dependence scores significantly. Subjects with negative urine before randomization (n = 26) had significantly greater abstinence on topiramate versus placebo during study weeks 6-12. Topiramate was safe and well tolerated.
Topiramate does not appear to promote abstinence in methamphetamine users but can reduce the amount taken and reduce relapse rates in those who are already abstinent.
托吡酯已显示出在促进酒精和可卡因滥用戒除方面的疗效。这项双盲、安慰剂对照的门诊试验测试了托吡酯治疗甲基苯丙胺成瘾的效果。
参与者(n=140)被随机分配接受托吡酯或安慰剂(13 周),剂量逐渐增加,从 25mg/天[剂量错误纠正]增加到第 6-12 周的目标维持剂量 200mg/天(第 13 周逐渐减少)。药物治疗与每周简短的行为依从性增强治疗相结合。
试验在美国的八个医疗中心进行。
140 名甲基苯丙胺依赖的成年人参加了试验。
主要结果是第 6-12 周期间戒除甲基苯丙胺。次要结果包括与基线相比的使用减少,以及心理社会变量。
在意向治疗分析中,托吡酯并没有增加第 6-12 周期间戒除甲基苯丙胺的比例。对于次要结果,托吡酯显著降低了每周尿中甲基苯丙胺的中位数水平和观察者评定的依赖严重程度评分。在随机分组前尿液呈阴性(n=26)的受试者在研究的第 6-12 周期间,接受托吡酯治疗的戒断率显著高于安慰剂。托吡酯安全且耐受良好。
托吡酯似乎不能促进甲基苯丙胺使用者的戒断,但可以减少已戒断者的用量和复发率。