Efficacy

Two double-blind randomized controlled studies in detoxified outpatients showed that naltrexone 50 mg daily reduces the risk of relapse over a 3-month treatment period/5,56> A subsequent study failed to find a significant treatment effect in the all-patient intention-to-treat analysis, but found a beneficial effect in a predefined subgroup of compliant patients (who had attended regularly for treatment and received 80 per cent of the prescribed study medication). (57) The effect size of naltrexone treatment in reducing the percentage of days drinking was 0.42 in one study and 0.60 in the other. (58) (For comparison, the mean effect size in meta-analyses of studies of fluoxetine in the treatment of depression is around 0.4.)

Follow-up has not indicated rapid relapse on cessation of these drugs. However, during a 6-month follow-up after 3 months of placebo-controlled treatment, patients relapsed gradually after naltrexone to a final rate similar to that seen in placebo-treated patients. (59)

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