Medical Department, Community Counseling Services Inc, Hot Springs, AR, USA.
J Clin Psychopharmacol. 2009 Oct;29(5):488-91. doi: 10.1097/JCP.0b013e3181b591e0.
Methamphetamine has become a major public health issue globally, particularly in the United States. Despite this, no effective pharmacotherapy for methamphetamine abuse has been developed to date. This 6-week, open-label pilot clinical trial examined the safety and tolerability of modafinil up to 400 mg/d in 8 methamphetamine-dependent individuals. Subjects were inducted onto modafinil at 400 mg/d for more than 3 days and remained on 400 mg/d for 4.5 weeks. Participants received weekly blister packs and underwent weekly individual cognitive behavioral therapy. Adjunctive contingency management procedures were used to enhance retention. Vital signs and supervised urine samples were obtained thrice weekly, and self-reported drug use and Hamilton anxiety and depression ratings were completed once weekly. Eight subjects (50% female, 100% white, aged 35-52 years) were enrolled. Four completed the 6-week study, 3 completed a portion, and 1 withdrew consent before completing intake. Results showed that systolic blood pressure (t = 1.09, P = 0.28), diastolic blood pressure, (t = 1.18, P = 0.24), and heart rate (t = 1.55, P = 0.13) did not change over time. Scores on the modafinil side effects checklist (t = -2.63, P = 0.01), Hamilton anxiety scale (t = -2.50, P = 0.018), and Hamilton depression scale (t = -3.25, P = 0.003) all decreased over time. The proportion of urine positive for amphetamines did not change over time (t = -0.52, P = 0.61), whereas self-reported methamphetamine use did (t = -2.86, P < 0.005). These results suggest that modafinil at 400 mg/d is safe and tolerable for methamphetamine-dependent individuals.
甲基苯丙胺已成为全球主要的公共卫生问题，特别是在美国。尽管如此，迄今为止尚未开发出有效的药物治疗方法来治疗甲基苯丙胺滥用。这项为期 6 周的、开放性标签的试点临床试验，在 8 名甲基苯丙胺依赖者中检查了莫达非尼的安全性和耐受性，剂量高达 400mg/天。受试者在 400mg/天的剂量下诱导超过 3 天，然后在 4.5 周内保持 400mg/天的剂量。参与者每周接受一次泡罩包装，并每周接受一次个体认知行为治疗。辅助性的效绩管理程序被用来提高保留率。每周三次采集生命体征和监督尿液样本，每周一次完成自我报告的药物使用和汉密尔顿焦虑和抑郁评分。8 名受试者（50%为女性，100%为白人，年龄 35-52 岁）入组。4 名受试者完成了 6 周的研究，3 名受试者完成了部分研究，1 名受试者在完成入组前撤回了同意。结果表明，收缩压（t = 1.09，P = 0.28）、舒张压（t = 1.18，P = 0.24）和心率（t = 1.55，P = 0.13）没有随时间变化。莫达非尼副作用检查表（t = -2.63，P = 0.01）、汉密尔顿焦虑量表（t = -2.50，P = 0.018）和汉密尔顿抑郁量表（t = -3.25，P = 0.003）的评分随时间均降低。尿液中安非他命呈阳性的比例随时间没有变化（t = -0.52，P = 0.61），而自我报告的甲基苯丙胺使用情况则有变化（t = -2.86，P < 0.005）。这些结果表明，400mg/天的莫达非尼对甲基苯丙胺依赖者是安全和耐受的。
