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Randomized trialNaltrexone for alcohol2004

De Sousa 2004: disulfiram beat naltrexone in men with family support

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

What it found

Disulfiram did better than naltrexone at preventing relapse: 86% of men on disulfiram stayed abstinent for the whole year, compared with 44% on naltrexone, and relapse came at 119 days on average versus 63. Men on naltrexone did report significantly less craving.

Abstinent all year, disulfiram
86%
Abstinent all year, naltrexone
44%
Average days to relapse, disulfiram
119 days
Average days to relapse, naltrexone
63 days

What they tested

A hundred men with alcohol dependence, each with a family member who would come with them to follow-up visits, were randomly given a year of naltrexone or disulfiram. It was a pragmatic trial, meaning it was run in routine clinical practice, and the patients, family members and psychiatrist all knew which drug each man was taking.

The psychiatrist recorded drinking, craving and side effects weekly for 3 months and then every two weeks for the rest of the year. A liver enzyme blood test, gamma-glutamyl transferase (GGT), was taken at the start and end. Relapse meant more than 5 drinks (40 g of alcohol) in 24 hours.

What they found

At the end of the year, 97 men were still in contact with the clinic.

Relapse happened at a mean of 119 days with disulfiram and 63 days with naltrexone (P = 0.020). Over the year, 86% of men on disulfiram stayed abstinent throughout, compared with 44% on naltrexone (P = 0.0009).

GGT, which didn't differ between groups at the start, averaged 117 U/l with naltrexone and 85 U/l with disulfiram at the end (P = 0.038).

Craving was significantly lower in men on naltrexone than in men on disulfiram.

Limits

  • Everyone, including the psychiatrist recording the results, knew which drug each man was on, which can bias the findings.
  • Only men took part, all with a family member involved in their care, so the results may not apply to women or to people without that support.
  • It took place in one setting in India, and the authors called for comparisons in other settings and other types of drinkers.
  • The abstract doesn't give the doses used.

What it means if you're considering naltrexone

In this head-to-head trial, with a family member involved in each man's care, disulfiram kept far more men abstinent than naltrexone did. The authors said the comparison needs repeating in other settings and with other types of drinkers.

For someone aiming for complete abstinence with a family member closely involved, this trial suggests disulfiram is worth discussing alongside naltrexone. Naltrexone lowered craving more, and unlike disulfiram it doesn't cause a sickness reaction with alcohol.

Frequently asked questions

Is disulfiram better than naltrexone?

In this one-year open-label trial of men in India with family support, disulfiram kept more men abstinent (86% vs 44%) and delayed relapse longer (119 vs 63 days). Naltrexone led to lower craving.

The paper

De Sousa A, De Sousa A. A one-year pragmatic trial of naltrexone vs disulfiram in the treatment of alcohol dependence. Alcohol Alcohol. 2004;39(6):528-531. doi:10.1093/alcalc/agh104

Read the paperdoi:10.1093/alcalc/agh104

We wrote this page from the paper's published abstract, and the study's numbers here come from there. Updated October 17, 2026.

Medical disclaimer

This page is for information only and is not medical advice, diagnosis, or treatment. Don't start, stop, or change any medicine — including naltrexone — without your prescriber. Naltrexone must not be used by people taking opioid pain medicines, people dependent on opioids, or people in opioid withdrawal (FDA label). In an emergency call 911; for crisis support call or text 988. Full medical disclaimer.