Naltrexone for the treatment of alcoholism: a meta-analysis of randomized controlled trials

Abstract

Many trials of naltrexone have been carried out in alcohol-dependent patients. This paper is aimed to systematically review its benefits, adverse effects, and discontinuation of treatment. We assessed and extracted the data of double-blind, randomized controlled trials (RCTs) comparing naltrexone with placebo or other treatment in people with alcoholism. Two primary outcomes were subjects who relapsed (including heavy drinking) and those who returned to drinking. Secondary outcomes were time to first drink, drinking days, number of standard drinks for a defined period, and craving. All outcomes were reported for the short, medium, and long term. Five common adverse effects and dropout rates in short-term treatment were also examined. A total of 2861 subjects in 24 RCTs presented in 32 papers were included. For short-term treatment, naltrexone significantly decreased relapses [relative risk (RR) 0.64, 95% confidence interval (CI) 0.51-0.82], but not return to drinking (RR 0.91, 95% CI 0.81-1.02). Short-term treatment of naltrexone significantly increased nausea, dizziness, and fatigue in comparison to placebo [RRs (95% CIs) 2.14 (1.61-2.83), 2.09 (1.28-3.39), and 1.35 (1.04-1.75)]. Naltrexone administration did not significantly diminish short-term discontinuation of treatment (RR 0.85, 95% CI 0.70-1.01). Naltrexone should be accepted as a short-term treatment for alcoholism. As yet, we do not know the appropriate duration of treatment continuation in an alcohol-dependent patient who responds to short-term naltrexone administration. To ensure that the real-world treatment is as effective as the research findings, a form of psychosocial therapy should be concomitantly given to all alcohol-dependent patients receiving naltrexone administration.

A Randomized Clinical Trial of Alcohol Care Management Delivered in Department of Veterans Affairs Primary Care Clinics Versus Specialty Addiction Treatment

“…12,13 Naltrexone in particular may be considered a first line treatment, as it has few side effects and is dosed only once per day. Naltrexone has been demonstrated in recent studies 14,15 and meta-analyses [16][17][18] to significantly reduce drinking days and the number of heavy drinking days.…”

Neurobiology of Substance-Related Addiction: Findings of Neuroimaging

“…In line with that, application of the opiate antagonist naltrexone in humans can reduce alcohol craving and the subjective "liking" of the drug associated with its intake (O'Brien, 2005) and might reduce the risk of relapse in some patients (e.g. Srisurapanont & Jarusuraisin, 2005).…”

Opioid pharmacogenetics of alcohol addiction

“…In the intervening 20 years, there have been more than 30 clinical trials of naltrexone in alcohol addiction (for review, see Bouza et al 2004;Srisurapanont and Jarusuraisin 2005;Pettinati et al 2006). Although the majority of these clinical trials show efficacy of naltrexone in reducing risk for relapse to heavy drinking, the effect size is small, with many patients having no benefit.…”