Trial of Alcohol Use Disorder Treatment Offered in Hepatology Clinic for Adults Newly Diagnosed with Alcohol-related Liver Disease

What this Trial Is About

Researchers are evaluating whether offering specialized alcohol use disorder AUD treatment directly in the hepatology clinic to patients newly diagnosed with alcohol-related liver disease ALD increases alcohol abstinence after 6 months. This randomized controlled superiority trial compares an intervention group offered AUD treatment against a control group receiving standard care. The study includes existing observational cohort members as additional controls and measures abstinence in the last 30 days at 6 months after randomization. Participants randomized to the intervention group receive standard care plus an offer of specialized AUD treatment from an experienced therapist in the hepatology clinic. Medical treatments for AUD to support abstinence are also offered. The control group receives standard care, which includes education about ALD and encouragement to stop alcohol use. Randomization occurs at the first visit in the observational cohort, and the trial uses a parallel group design with blinding of hypothesis and outcome assessment. During the study, participants are followed up at 3, 6, and 12 months to assess self-reported alcohol abstinence and biomarker levels of phosphatidylethanol. Additional measures include rates and duration of AUD treatment, reductions in alcohol consumption, and liver disease complications over 3 years. Participants provide informed consent and must meet specific liver stiffness and alcohol consumption criteria. The total study period extends up to 3 years for long-term monitoring of health outcomes.

Alcohol Misuse Treatment to Patients Newly Diagnosed With Alcohol-related Liver Disease: a Randomized Controlled Trial