Objectives: Little is known about whether safety and effectiveness of high-dose naltrexone (150 mg/d) are different in alcohol-dependent women and men. This study investigated sex differences in safety and treatment outcomes in alcohol-dependent women and men on high-dose naltrexone (150 mg/d).

Methods: In this exploratory study, safety and effectiveness of high-dose naltrexone (150 mg/d) were examined in men and women with alcohol dependence (n = 24; 11 men and 13 women) treated in an 8-week outpatient setting.

Results: Women and men had similar dropout rates, adverse effects, tolerability, and hepatic function during high-dose naltrexone treatment (150 mg/d). Drinking outcomes were significantly improved in both women and men, but no sex differences were found.

Conclusions: High-dose naltrexone seems to be well tolerated, safe, and effective in both men and women with alcohol dependence in this small study. Given the small sample size of the current study, our results cannot be considered definitive, and larger trials with longer durations are needed to confirm these findings.

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