Sangroula Dinesh, Motiwala Fatima, Wagle Bivek, Shah Vivek C, Hagi Katsuhiko, Lippmann Steven
a Department of Psychiatry , Jamaica Hospital Medical Center , New York , New York , USA.
b Department of Psychiatric Research , Columbia University Medical Center , New York , New York , USA.
Subst Use Misuse. 2017 Aug 24;52(10):1292-1306. doi: 10.1080/10826084.2016.1276597. Epub 2017 Mar 28.
Currently, there is none FDA-approved medication to treat cocaine dependency. Studies conducted with various medications, including antipsychotics, antidepressants, anticonvulsants, and others, revealed inconsistent results.
To meta-analytically investigate the efficacy and safety of modafinil in the treatment of cocaine-dependent patients.
Randomized controlled trials with ≥20 subjects comparing the numerical therapeutic outcomes of modafinil with placebo were identified in databases, such as PUBMED, psycINFO, EMBASE, and Clinicaltrials.gov. Relevant data on efficacy and safety were extracted. Relative risk (RR) and standardized mean difference were applied for reporting dichotomous and continuous outcomes respectively. Random effects, subgroup, and meta-regression analyses were conducted to further explore the results and evaluate for any moderators.
In total, 11 studies (participants = 896, duration = 6.7 ± 1.9 weeks) comparing modafinil with placebo were systematically analyzed, which indicated that modafinil was not superior to placebo in improving the treatment retention rate (studies = 11, participants = 891, RR = 1.030, 95% CI = 0.918-1.156, p = .613). Similarly, data from 7/11 studies did not evidence superiority of modafinil in achieving cocaine abstinence (participants = 696, RR = 1.259, 95% CI = 0.813-1.949, p = .302). However, subgroup analysis of six studies conducted in the United States demonstrated superiority of modafinil in cocaine abstinence rate (studies = 6, participants = 669, 95% CI = 1.027-2.020, p = 0.035). In addition, no evidence suggested modafinil-related discontinuation or specific adverse events than placebo.
Overall, there is no evidence to conclude superiority of modafinil in increasing cocaine abstinence and treatment retention rate. However, promising result in subgroup analysis of cocaine abstinence, secondary outcomes, and good safety profile urged the need of larger studies to derive more conclusive results.
目前，尚无美国食品药品监督管理局（FDA）批准的用于治疗可卡因依赖的药物。使用包括抗精神病药、抗抑郁药、抗惊厥药等多种药物进行的研究结果并不一致。
采用荟萃分析方法研究莫达非尼治疗可卡因依赖患者的疗效和安全性。
在诸如PUBMED、psycINFO、EMBASE和Clinicaltrials.gov等数据库中，识别出受试者≥20例、比较莫达非尼与安慰剂疗效的随机对照试验。提取有关疗效和安全性的相关数据。分别应用相对危险度（RR）和标准化均数差来报告二分法和连续性结果。进行随机效应、亚组和荟萃回归分析以进一步探究结果并评估任何调节因素。
共系统分析了11项比较莫达非尼与安慰剂的研究（参与者 = 896例，疗程 = 6.7 ± 1.9周），结果表明在提高治疗保留率方面，莫达非尼并不优于安慰剂（研究 = 11项，参与者 = 891例，RR = 1.030，95%置信区间 = 0.918 - 1.156，p = 0.613）。同样，11项研究中的7项数据也未证明莫达非尼在实现可卡因戒断方面具有优势（参与者 = 696例，RR = 1.259，95%置信区间 = 0.813 - 1.949，p = 0.302）。然而，在美国进行的6项研究的亚组分析显示，莫达非尼在可卡因戒断率方面具有优势（研究 = 6项，参与者 = 669例，95%置信区间 = 1.027 - 2.020，p = 0.035）。此外，没有证据表明莫达非尼组因药物相关原因停药或出现比安慰剂组更特殊的不良事件。
总体而言，没有证据表明莫达非尼在提高可卡因戒断率和治疗保留率方面具有优势。然而，可卡因戒断亚组分析的有前景结果、次要结局以及良好的安全性促使需要开展更大规模的研究以得出更具结论性的结果。
