{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,3]],"date-time":"2026-10-03T15:35:07Z","timestamp":1791041707840,"version":"4.1.0"},"reference-count":28,"publisher":"Wiley","issue":"9","license":[{"start":{"date-parts":[[2026,8,19]],"date-time":"2026-08-19T00:00:00Z","timestamp":1787097600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"},{"start":{"date-parts":[[2026,8,19]],"date-time":"2026-08-19T00:00:00Z","timestamp":1787097600000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Liver International"],"published-print":{"date-parts":[[2026,9]]},"abstract":"ABSTRACT<\/jats:title>\n \n Background and Aims<\/jats:title>\n Alcohol use disorder (AUD) coexisting with cirrhosis carries high morbidity and mortality, with no approved pharmacotherapy for AUD. We evaluated the safety and efficacy of naltrexone, an opioid receptor antagonist, in patients with compensated alcohol\u2010associated cirrhosis (AaC) and AUD.<\/jats:p>\n <\/jats:sec>\n \n Methods<\/jats:title>\n One hundred patients with compensated AaC and DSM\u20105 AUD were randomised 1:1 to naltrexone (50\u2009mg\/day) or placebo for 12\u2009weeks. The primary endpoint was point\u2010prevalence abstinence at 12\u2009weeks, defined as no alcohol use in the four preceding weeks. Secondary endpoints included craving (Obsessive Compulsive Drinking Scale [OCDS]\u2014Obsessive and Compulsive subscales), lapses, relapses, and hepatic safety. Standardised psychosocial support was provided to both arms.<\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n \n Baseline characteristics were well matched between groups (mean MELD 12.6 vs. 12.7; CTP score 5.9 vs. 6.2; age 42.9 vs. 44.3\u2009years). AUDIT and OCDS scores were comparable between groups. Abstinence at 12\u2009weeks was significantly higher with naltrexone: 64% (32\/50) versus 22% (11\/50),\n p<\/jats:italic>\n \u2009<\u20090.001; OR 10.86 (95% CI: 1.89\u201362.2). Naltrexone significantly reduced lapses at 3\u2009months (28% vs. 54%,\n p<\/jats:italic>\n \u2009=\u20090.008) and showed a trend toward fewer heavy\u2010drinking relapses (12% vs. 28%,\n p<\/jats:italic>\n \u2009=\u20090.07). Maintenance of abstinence at 6\u2009months favoured naltrexone (22% vs. 8%,\n p<\/jats:italic>\n \u2009=\u20090.09). No patient developed hepatic decompensation attributable to study medication, and no AST\/ALT elevation exceeding 5\u00d7 ULN was observed in either group. Mean craving scores were lower with naltrexone by week 12 than with placebo: OCDS\u2010O score (6.63\u2009\u00b1\u20091.16 vs. 9.29\u2009\u00b1\u20091.78,\n p<\/jats:italic>\n \u2009<\u20090.01) and OCDS\u2010C score (6.35\u2009\u00b1\u20091.23 vs. 9.02\u2009\u00b1\u20091.86,\n p<\/jats:italic>\n \u2009<\u20090.01). Adverse events were comparable between the groups.\n <\/jats:p>\n <\/jats:sec>\n \n Conclusion<\/jats:title>\n Naltrexone is safe and effective in patients with compensated alcohol\u2010associated cirrhosis, achieving a threefold higher abstinence rate and significantly reducing craving compared with placebo. These findings support the use of naltrexone as a pharmacological option in patients with compensated AaC and AUD.<\/jats:p>\n <\/jats:sec>\n \n Trial Registration<\/jats:title>\n NCT04391764<\/jats:p>\n <\/jats:sec>","DOI":"10.1111\/liv.70845","type":"journal-article","created":{"date-parts":[[2026,8,19]],"date-time":"2026-08-19T09:23:46Z","timestamp":1787131426000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["Naltrexone Is Superior to Placebo for Abstinence and Craving Reduction in Alcohol\u2010Associated Cirrhosis:\n NAL<\/scp>\n \u2010\n CI<\/scp>\n Trial"],"prefix":"10.1111","volume":"46","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-5318-2897","authenticated-orcid":false,"given":"Manasa","family":"Alla","sequence":"first","affiliation":[{"name":"Department of Hepatology Institute of Liver and Biliary Sciences New Delhi India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6426-4051","authenticated-orcid":false,"given":"Mohit","family":"Varshney","sequence":"additional","affiliation":[{"name":"Department of Psychiatry Institute of Liver and Biliary Sciences New Delhi India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5380-2782","authenticated-orcid":false,"given":"Ankit","family":"Bhardwaj","sequence":"additional","affiliation":[{"name":"Department of Clinical Research and Biostatistics Institute of Liver and Biliary Sciences New Delhi India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Guresh","family":"Kumar","sequence":"additional","affiliation":[{"name":"Department of Clinical Research and Biostatistics Institute of Liver and Biliary Sciences New Delhi India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5846-6263","authenticated-orcid":false,"given":"S. M.","family":"Shasthry","sequence":"additional","affiliation":[{"name":"Department of Hepatology Institute of Liver and Biliary Sciences New Delhi India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0544-5610","authenticated-orcid":false,"given":"Shiv Kumar","family":"Sarin","sequence":"additional","affiliation":[{"name":"Department of Hepatology Institute of Liver and Biliary Sciences New Delhi India"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,8,19]]},"reference":[{"key":"e_1_2_13_2_1","doi-asserted-by":"publisher","DOI":"10.1002\/hep.29240"},{"key":"e_1_2_13_3_1","doi-asserted-by":"publisher","DOI":"10.1002\/hep.29338"},{"key":"e_1_2_13_4_1","doi-asserted-by":"publisher","DOI":"10.1111\/apt.16831"},{"key":"e_1_2_13_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.coph.2021.11.012"},{"key":"e_1_2_13_6_1","doi-asserted-by":"publisher","DOI":"10.1097\/CLD.0000000000000033"},{"key":"e_1_2_13_7_1","doi-asserted-by":"publisher","DOI":"10.1080\/10550490802544391"},{"key":"e_1_2_13_8_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(07)61814-5"},{"issue":"11","key":"e_1_2_13_9_1","article-title":"Baclofen for Alcohol Use Disorder","volume":"11","author":"Minozzi S.","year":"2018","journal-title":"Cochrane Database of Systematic Reviews"},{"key":"e_1_2_13_10_1","doi-asserted-by":"publisher","DOI":"10.1093\/alcalc\/agr017"},{"key":"e_1_2_13_11_1","doi-asserted-by":"publisher","DOI":"10.1176\/appi.ajp.2017.1750101"},{"key":"e_1_2_13_12_1","doi-asserted-by":"publisher","DOI":"10.1177\/0269881109102623"},{"key":"e_1_2_13_13_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40263-015-0244-0"},{"key":"e_1_2_13_14_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1360-0443.2009.02792.x"},{"key":"e_1_2_13_15_1","doi-asserted-by":"publisher","DOI":"10.1111\/adb.12425"},{"key":"e_1_2_13_16_1","doi-asserted-by":"publisher","DOI":"10.1080\/02791072.2022.2073300"},{"key":"e_1_2_13_17_1","doi-asserted-by":"publisher","DOI":"10.1097\/QAI.0000000000000922"},{"key":"e_1_2_13_18_1","doi-asserted-by":"publisher","DOI":"10.1046\/j.1440-1614.2001.00935.x"},{"key":"e_1_2_13_19_1","doi-asserted-by":"publisher","DOI":"10.1093\/alcalc\/35.6.587"},{"key":"e_1_2_13_20_1","doi-asserted-by":"publisher","DOI":"10.1002\/hep4.2080"},{"key":"e_1_2_13_21_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jhepr.2024.101095"},{"key":"e_1_2_13_22_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jceh.2024.102447"},{"key":"e_1_2_13_23_1","doi-asserted-by":"publisher","DOI":"10.1097\/HC9.0000000000000093"},{"key":"e_1_2_13_24_1","doi-asserted-by":"publisher","DOI":"10.1001\/archpsyc.1996.01830030047008"},{"key":"e_1_2_13_25_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2044.1976.tb11971.x"},{"key":"e_1_2_13_26_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41575-024-00936-x"},{"key":"e_1_2_13_27_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2014.3628"},{"key":"e_1_2_13_28_1","doi-asserted-by":"publisher","DOI":"10.1176\/appi.ajp.20220335"},{"key":"e_1_2_13_29_1","doi-asserted-by":"publisher","DOI":"10.1080\/00952990802082198"}],"container-title":["Liver International"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/liv.70845","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1111\/liv.70845","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/liv.70845","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,8,27]],"date-time":"2026-08-27T11:23:52Z","timestamp":1787829832000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/liv.70845"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,8,19]]},"references-count":28,"journal-issue":{"issue":"9","published-print":{"date-parts":[[2026,9]]}},"alternative-id":["10.1111\/liv.70845"],"URL":"https:\/\/doi.org\/10.1111\/liv.70845","archive":["Portico"],"relation":{},"ISSN":["1478-3223","1478-3231"],"issn-type":[{"value":"1478-3223","type":"print"},{"value":"1478-3231","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,8,19]]},"assertion":[{"value":"2026-06-05","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-08-03","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-08-19","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e70845"}}