Commentary on Ling et al. (2012): The PROMETA™ treatment does not reduce methamphetamine use.
Commentary on Ling et al. (2012): The PROMETA™ treatment does not reduce methamphetamine use.
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DOI：
10.1111/j.1360-0443.2011.03696.x
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发表时间：
2012
期刊：
影响因子：
--
通讯作者：
Sofuoglu,Mehmet
中科院分区：
文献类型：
--
作者：
Sofuoglu,Mehmet
Ling et al. tested the efficacy and safety of the PROMETA protocol for the treatment of methamphetamine addiction in a double-blind, placebo-controlled study (1). The PROMETA protocol has been widely promoted as a treatment for alcohol, cocaine, and methamphetamine addiction although its safety and efficacy have not been definitively evaluated in rigorous clinical trials. Ling et al. report that the PROMETA protocol was no more effective than placebo in reducing either methamphetamine use or craving for methamphetamine. The protocol includes a combination of flumazenil, gabapentin, and hydroxyzine. Flumazenil is a benzodiazepine antagonist typically used for benzodiazepine overdose (2). Gabapentin, on the other hand, is used for treatment of seizures and pain, possibly acts by inhibiting the alpha2delta type of calcium receptors, although the exact mechanism of action is unclear (3). Hydroxyzine is an H1-histaminic receptor antagonist with anticholinergic effects (4). The authors deserve credit for successfully testing the safety and efficacy of this challenging protocol. This study raises several additional questions some of which are summarized below:The first question is related to the justification for this study. Neither the components of the PROMETA medication cocktail nor the sequence and time-course of their administration is supported by any scientific rationale. Presumably, the resources used for this study could have been used to conduct studies with a clearer scientific rationale. On the other hand, the PROMETA protocol has been widely used in specialized clinics as a treatment of alcohol, cocaine, and methamphetamine addiction without systematic studies supporting its safety and efficacy. The trial is thus warranted to test this practice. Further, in a previous doubleblind, placebo-controlled-study, Urschel et al reported that the PROMETA protocol reduced methamphetamine use as well as craving (5). Because the Urschel study was only a 30 day study, there was a need for further studies with longer treatment duration to test the safety and efficacy of PROMETA combination in methamphetamine users. Thus, although a clear scientific rationale was lacking, the widespread use of the protocol and some preliminary findings supporting its efficacy sufficiently justified this clinical trial.
