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

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Naltrexone and disulfiram are both used as deterrent agents in Naltrexone is an opioid receptor agonist that reduces the euphoria associated with alcohol consumption and thus reduces the risk of relapse in alcohol-dependent individuals. Disulfiram blocks the metabolism of acetaldehyde, an intermediate product of alcohol metabolism. Upon consumption of alcohol, increased acetaldehyde levels cause a disulfiram-ethanol reaction, which includes flushing, nausea, vomiting, and a sense of uneasiness. Researchers in Mumbai, India, compared the efficacy of naltrexone and disulfiram in alcohol treatment for dependence in a one-year trial (De Sousa & De Sousa, 2004).

The researchers recruited 100 alcohol dependent men who had a family member that could accompany the participants to follow-up appointments. Participants randomly received either disulfiram or naltrexone for a year. The patients, the accompanying family member, and the treating psychiatrist were aware of the treatment given. (This was not a double-blind trial.) Measures included alcohol consumption, craving, and adverse events as recorded by the treating psychiatrist. Serum gamma-glutamyl transferase (GGT) was also measured at the start and the end of the study. (Elevated levels of GGT may indicate alcohol abuse or liver disease.)

Results of the study revealed that 97 out of 100 patients were still in contact at the end of the study. Relapse was defined as the consumption of more than five drinks in a 24-hour period and occurred at a mean of 119 days with disulfiram and at 63 days with naltrexone. Mean GGT did not differ between the two groups initially; however, at the end of the study, mean GGT was 117 U/l with naltrexone and 85 U/l with disulfiram. Of the participants who received disulfiram, 86 percent remained abstinent for the entire year of the study, compared to 44 percent of those who received naltrexone. On the other hand, those who received naltrexone reported significantly lower craving. The authors concluded that disulfiram is superior to naltrexone in preventing relapse among alcohol-dependent men with family support in alcohol treatment, and they suggest other comparisons in other settings with different types of individuals. The location and culture of the study may also affect results, as the authors suggest.: “In India there are more joint families than nuclear and hence there is usually more than one member of the family willing to monitor the supervised medication, therefore we assigned one member to take the responsibility and the same member was advised to be with the patient at the time of follow-up… In about 75–80 cases the patient’s spouse monitored the treatment whereas in the rest either the parents (mother or father) or a brother/sister monitored the same.”

The authors concluded, “Previous studies have shown that the outcome is best when the administration of disulfiram is monitored under family supervision. Naltrexone however had a better outcome in terms of reduction in craving. It is difficult to compare these results with that of other studies as this is perhaps the first published study that compares these two drugs in such a large number of patients. In terms of tolerability, the group treated with naltrexone experienced more side-effects, but these were limited to the first 15 days of the study and did not influence the incidence of drop-outs from the study.”

De Sousa, Alan & De Sousa, Avinash. A one-year pragmatic trial of naltrexone vs disulfiram in the treatment of alcohol dependence. Alcohol and Alcoholism. 2004; 39(6): 528-531.

http://alcalc.oxfordjournals.org/cgi/content/full/39/6/528