Status:
RECRUITING
Alcohol Misuse Treatment to Patients Newly Diagnosed With Alcohol-related Liver Disease: a Randomized Controlled Trial
Lead Sponsor:
Zealand University Hospital
Collaborating Sponsors:
Center for Clinical Research and Prevention
Novavi Outpatient Clinics
Conditions:
Liver Diseases, Alcoholic
Alcohol Use Disorder
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 rand...
Detailed Description
The investigators have designed a randomized controlled superiority trial to investigate the effectiveness of systematically offering AUD treatment in the hepatology clinic to newly diagnosed ALD pati...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
November 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2029
Estimated Enrollment :
221 Patients enrolled
Trial Details
Trial ID
NCT06493773
Start Date
November 15 2025
End Date
April 1 2029
Last Update
November 18 2025
Active Locations (1)
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1
Department of Medicine, Zealand University Hospital
Køge, Køge, Denmark, 4600