A one-year pragmatic trial of naltrexone vs disulfiram in the treatment of alcohol dependence.

AIMS: To compare the efficacy of naltrexone and disulfiram in preventing an alcoholic relapse in routine clinical practice in an Indian metropolis.

METHODS

Hundred alcohol-dependent men, for whom a family member would accompany the patient to follow-up appointments, were randomly allocated to a year of treatment with either naltrexone or disulfiram. Patients, the accompanying family member and the treating psychiatrist were aware of the nature of treatment given. Alcohol consumption, craving and adverse events were recorded weekly for the first three months, then fortnightly for the rest of the year, by the treating psychiatrist. Serum gamma-glutamyl transferase (GGT) was measured at the start and the end of the study.

RESULTS

At the end of the year, 97 patients were still in contact. Relapse, the consumption of >5 drinks (40 g of ethanol) in a 24 h period, occurred at a mean of 119 days with disulfiram and at 63 days with naltrexone (P = 0.020). Mean serum GGT, which had not differed between the two groups initially, was 117 U/l with naltrexone and 85 U/l with disulfiram (P = 0.038) at the end of the study. Eighty-six per cent of the patients remained abstinent throughout the study with disulfiram compared to 44% with naltrexone (P = 0.0009). However, patients allocated to naltrexone had significantly lower craving than those allocated to disulfiram.

CONCLUSIONS

Disulfiram is superior to naltrexone in preventing a relapse among alcohol-dependent men with family support. Comparison between these treatments in other settings and in different types of alcoholics is warranted.