Naltrexone achieves abstinence, reduces lapses in patients with alcohol use disorder
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Naltrexone was effective in achieving abstinence, reducing lapses and improving craving scores at 3 months in patients with alcohol-related cirrhosis, according to data presented at EASL Congress.
“In the largest randomized controlled trial available to date, which is a combined trial with 1,380 patients with alcohol use disorder, naltrexone has been shown to have an increased incidence of abstinence and also reduced heavy drinking days,” Manasa Alla, MD, of the Institute of Liver and Biliary Sciences in New Delhi, said.
Seeking to assess the safety and efficacy of naltrexone in patients with alcohol-related cirrhosis, Alla and colleagues conducted a double-blind, randomized, placebo-controlled trial of 100 adults aged 18 to 60 years with alcohol use disorder and compensated cirrhosis. Participants received naltrexone (n = 50; mean age, 45 years; 100% men) or placebo (n = 50; mean age, 46.9 years; 100% men) for 12 weeks.
The primary outcome was the proportion of patients who achieved and maintained alcohol abstinence at 12 weeks, while secondary outcomes included the proportion of patients who maintained abstinence at 6 and 12 months, liver-related adverse effects at 12 weeks, lapses and relapses at 3, 6 and 12 months, and differences in craving measures between groups.
At each visit, researchers assessed participant drinking and abstinence from alcohol, overall functioning, treatment adherence and adverse effects. Psychological support and counseling was provided as well.
At 3 months, 64% of patients in the naltrexone group and 22% of patients in the placebo group achieved abstinence. At 6 months, the abstinence rate remained higher, although not statistically significant, in the naltrexone group (22% vs. 8%).
Further, patients in the naltrexone group had a lower rate of lapses compared with the placebo group at 3 months (28% vs. 72%) and 6 months (58% vs. 78%). Relapses were also lower in the naltrexone group at 3 months (12% vs. 28%) and 6 months (12% vs. 22%), although not statistically significant.
Alla also noted that obsessive-compulsive drinking scale scores were significantly lower in the naltrexone group vs. placebo at 12 weeks.
In univariate analysis, drinks per month (HR = 1.484; 95% CI, –12.65 to –6.695) and use of naltrexone vs. placebo (HR = 11; 95% CI, 2.9-41.69) predicted abstinence. These results remained consistent in multivariate analysis (HR = 1.304; 95% CI, 1.14-1.49 and HR = 10.86; 95% CI, 1.89-62.2).
The most common adverse events were nausea (6.8% vs. 11.1%) and vomiting (10.3% vs. 7.4%). One patient discontinued naltrexone.
“Naltrexone is effective in achieving abstinence at 3 months,” Alla concluded. “It is safe to be used in patients with compensated cirrhosis, it reduced lapses at 3 months and also improved cravings scores.”
She continued: “We need more studies with longer duration of usage of the drug, and head-to-head trials in comparison with other drugs are needed.”
Perspective
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Akhil Anand, MD
For individuals with alcoholic cirrhosis, abstaining from alcohol is the primary therapeutic goal, as abstinence can significantly improve outcomes at all stages of disease.
Currently, there are no FDA-approved medications for alcohol use disorder specifically approved for patients with alcoholic cirrhosis. This restricts the range of treatment options available for this vulnerable population.
Naltrexone is a first-line agent used in alcohol use disorder. It consistently has shown superiority over placebo and other addiction medicines in treating alcohol use disorder.
In this study, the authors concluded that naltrexone can safely be prescribed in patients with concurrent alcoholic cirrhosis and alcohol use disorder, a promising finding that supports previous studies. However, further research is needed to demonstrate naltrexone’s safety in treating patients with compensated alcoholic cirrhosis outside specialty hepatology clinics.
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Alla M, et al. Abstract GS-008-YI: Naltrexone is safe and effective in achieving abstinence and reducing alcohol craving in cirrhotic patients: A double blind randomized placebo-controlled trial. Presented at: EASL Congress; June 21-23, 2023; Vienna (hybrid meeting).
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