Safety, tolerability, and feasibility of high-dose naltrexone in alcohol dependence: An open-label study

Objective Prior trials testing standard-dose naltrexone (50mg/day) have generated mixed results in the treatment of alcohol dependence. The purpose of this study was to evaluate the short-term safety, tolerability, and feasibility of high-dose naltrexone (150mg/day) for treating alcohol-dependent patients with prominent alcohol craving. Methods Twenty-four alcohol-dependent outpatients received high-dose naltrexone at a dose of 150mg/day in an 8-week open-label pilot study. All patients had current alcohol dependence and alcohol craving symptoms. Safety and tolerability were assessed weekly. Liver function tests were obtained at weeks 0, 3, 5, 7, and 9. The main outcome measures were percentage of drinking days and number of drinks per drinking day. Results High-dose naltrexone was safe and well tolerated using the procedure described. No serious adverse effects were reported. The mean of γ-glutamyl transferase showed an improvement trend (p=0.06), and other hepatic transaminase profiles were stable during the trial. High-dose naltrexone significantly reduced alcohol consumption (percentage of drinking days (p<0.0001); and number of drinks per drinking day (p<0.0001)). Conclusions High-dose naltrexone may serve as a viable treatment option for alcohol-dependent patients with prominent alcohol craving. Further controlled studies are needed to confirm our findings.