BACKGROUND: Clinical trials have shown that naltrexone 50 mg/day reduces alcohol consumption and relapse rates in alcohol dependents. AIM: To investigate the efficacy of 50mg/day dose of naltrexone in the maintenance of alcohol-dependent subjects over a 36-week treatment period. METHODS: Subjects were randomised into two equal groups, consisting of 116 male alcohol-dependent patients who met the DSM-IV criteria for alcohol dependence and were seeking treatment. The participants received naltrexone or placebo at a dose of 50 mg/day and were treated in an outpatient clinic, offering a weekly 0.5-hour individual counselling session. Days retained in treatment were measured. RESULTS:Forty-one participants (35.3%) completed the 36-week study. Completion rates by group were 44.8% for the 50 mg naltrexone group and 25.9% for the placebo group (chi2=4.56, DF=1, 2-sided significance=0.033). CONCLUSION: The results support the efficacy and safety of naltrexone for outpatient treatment of alcohol-dependent individuals in Iran.
RCT Entities:
BACKGROUND: Clinical trials have shown that naltrexone 50 mg/day reduces alcohol consumption and relapse rates in alcohol dependents. AIM: To investigate the efficacy of 50mg/day dose of naltrexone in the maintenance of alcohol-dependent subjects over a 36-week treatment period. METHODS: Subjects were randomised into two equal groups, consisting of 116 male alcohol-dependent patients who met the DSM-IV criteria for alcohol dependence and were seeking treatment. The participants received naltrexone or placebo at a dose of 50 mg/day and were treated in an outpatient clinic, offering a weekly 0.5-hour individual counselling session. Days retained in treatment were measured. RESULTS: Forty-one participants (35.3%) completed the 36-week study. Completion rates by group were 44.8% for the 50 mg naltrexone group and 25.9% for the placebo group (chi2=4.56, DF=1, 2-sided significance=0.033). CONCLUSION: The results support the efficacy and safety of naltrexone for outpatient treatment of alcohol-dependent individuals in Iran.
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