University of California, Los Angeles, 90025, USA.
Addiction. 2012 Feb;107(2):361-9. doi: 10.1111/j.1360-0443.2011.03619.x. Epub 2011 Nov 15.
To evaluate the efficacy and safety of the PROMETA™ Protocol for treating methamphetamine dependence.
A double-blind, placebo-controlled 108-day study with random assignment to one of two study conditions: active medication with flumazenil (2 mg infusions on days 1, 2, 3, 22, 23), gabapentin (1200 mg to day 40) and hydroxazine (50 mg to day 10) versus placebo medication (with active hydroxazine only).
Three substance abuse treatment clinics: two in-patient, one out-patient.
Treatment-seeking, methamphetamine-dependent adults (n = 120).
Primary outcome was percentage of urine samples testing negative for methamphetamine during the trial.
No statistically significant between-group differences were detected in urine drug test results, craving, treatment retention or adverse events.
The PROMETA protocol, consisting of flumazenil, gabapentin and hydroxyzine, appears to be no more effective than placebo in reducing methamphetamine use, retaining patients in treatment or reducing methamphetamine craving.
评估 PROMETA™ 方案治疗甲基苯丙胺依赖的疗效和安全性。
一项为期 108 天的双盲、安慰剂对照研究，随机分配到两种研究条件之一：使用氟马西尼（第 1、2、3、22、23 天 2 毫克输注）、加巴喷丁（第 40 天 1200 毫克）和羟嗪（第 10 天 50 毫克）的活性药物与安慰剂药物（仅含活性羟嗪）。
三个物质滥用治疗诊所：两个住院，一个门诊。
寻求治疗的、甲基苯丙胺依赖的成年人（n = 120）。
主要结果是试验期间尿液样本中检测到的甲基苯丙胺呈阴性的百分比。
在尿液药物检测结果、渴求、治疗保留或不良事件方面，两组之间没有统计学上显著的差异。
由氟马西尼、加巴喷丁和羟嗪组成的 PROMETA 方案似乎并不比安慰剂更能减少甲基苯丙胺的使用、保留患者治疗或减少甲基苯丙胺的渴求。
