Randomized trialNaltrexone for alcohol2026
Alla 2026 (NAL-CI): naltrexone for drinking in people with cirrhosis
Alla M, Varshney M, Bhardwaj A, Kumar G, Shasthry SM, Sarin SK. Naltrexone is superior to placebo for abstinence and craving reduction in alcohol-associated cirrhosis: NAL-CI trial
What it found
In 100 people with compensated alcohol-associated cirrhosis, 64% on naltrexone 50 mg a day were abstinent at 12 weeks compared with 22% on placebo. No patient had liver decompensation attributed to the drug, and no one in either group had an AST or ALT rise above 5 times the upper limit of normal.
- Abstinent at 12 weeks, naltrexone
- 64% (32/50)
- Abstinent at 12 weeks, placebo
- 22% (11/50)
- Lapsed by 3 months, naltrexone vs placebo
- 28% vs 54%
- Odds ratio for abstinence
- OR 10.86
What they tested
Researchers randomly assigned 100 people with alcohol use disorder and compensated alcohol-associated cirrhosis, meaning liver scarring without major complications, to naltrexone 50 mg a day or a placebo for 12 weeks. Both groups got the same standard psychosocial support.
The main outcome was abstinence at 12 weeks, defined as no alcohol in the four weeks before. The team also measured craving with the Obsessive Compulsive Drinking Scale, along with lapses, relapses and liver safety.
What they found
Abstinence at 12 weeks was 64% (32 of 50) with naltrexone and 22% (11 of 50) with placebo (p < 0.001). The odds ratio was 10.86, but its wide confidence interval (1.89 to 62.2) means the true size of the effect is uncertain.
Fewer people on naltrexone had a lapse by 3 months (28% vs 54%, p = 0.008). Heavy-drinking relapses were less common (12% vs 28%), but that difference was not statistically significant (p = 0.07), and neither was the difference in maintained abstinence at 6 months (22% vs 8%, p = 0.09).
By week 12, craving scores were lower with naltrexone on both parts of the craving scale: 6.63 vs 9.29 on the obsessive subscale and 6.35 vs 9.02 on the compulsive subscale.
No one developed liver decompensation attributable to the study drug, no AST or ALT rise above 5 times the upper limit of normal was seen in either group, and adverse events were similar between groups.
Limits
- Only people with compensated cirrhosis took part, so it says nothing about people with more advanced liver disease.
- With 100 people, the estimates are imprecise, as the wide confidence interval for abstinence shows.
- Treatment lasted 12 weeks, and the difference at 6 months was not statistically significant.
What it means if you're considering naltrexone
The authors note there is no approved alcohol medicine for people with cirrhosis. In this trial, naltrexone led to more people stopping drinking without signs of liver harm, which adds randomized evidence to records studies such as the VA cirrhosis study. It applies to compensated cirrhosis only, and the site's liver tests guide notes the evidence gaps at the severe end.
Frequently asked questions
Can you take naltrexone if you have cirrhosis?
In this 12-week trial of people with compensated cirrhosis, naltrexone 50 mg a day did not cause liver decompensation or large liver enzyme rises. People with more advanced cirrhosis were not included.
The paper
Alla M, Varshney M, Bhardwaj A, Kumar G, Shasthry SM, Sarin SK. Naltrexone is superior to placebo for abstinence and craving reduction in alcohol-associated cirrhosis: NAL-CI trial. Liver Int. 2026;46(9):e70845. doi:10.1111/liv.70845
Read the paperdoi:10.1111/liv.70845
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.