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

RecruitingNAAges 18 Years - anyAllZealand University Hospital
NCT06493773 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

To evaluate the efficacy of systematically offering newly diagnosed ALD patients to AUD treatment, in the hepatology clinic, on alcohol abstinence after 6 months. The investigators will conduct a randomized controlled superiority trial with parallel group design, hypothesis blinding and blinded outcome assessment comparing A) a offer to specialized AUD treatment (intervention) and B) standard care (control). Existing observational cohort ALD members will contribute to the control group in addition to the randomized controls. The primary outcome is abstinence throughout the last 30 days assessed 6 months after randomization.

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📋 Eligibility rules (as published)
Inclusion criteria * Age \> 18 years * Newly diagnosed alcohol-related liver disease, defined as within six months from baseline visit. * A liver stiffness above 8.0 kPa with 10 successful measurements and an interquartile range of less than 30% as assessed with transient elastography. * Excessive alcohol consumption defined as \>7 units/week for women and \>14 units/week for men within the previous year. * The patient is able to understand the purpose of the study and give informed oral and written consent to participate. Exclusion criteria * Not enough proficiency in Danish to participate in interviews and questionnaires. * Pregnancy * Ongoing specialized AUD treatment. Self-help groups and AUD counselling at general practitioners are not counting as specialized AUD treatment in this study.
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What it tests

  • Offer of specialized alcohol use disorder treatment in the hepatology clinic
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Where

1 site
Department of Medicine, Zealand University Hospital
Køge, Denmark
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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