Actively Recruiting
Alcohol Misuse Treatment to Patients Newly Diagnosed With Alcohol-related Liver Disease: a Randomized Controlled Trial
Led by Zealand University Hospital · Updated on 2025-11-18
221
Participants Needed
1
Research Sites
176 weeks
Total Duration
On this page
Sponsors
Z
Zealand University Hospital
Lead Sponsor
C
Center for Clinical Research and Prevention
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Alcohol Misuse Treatment to Patients Newly Diagnosed With Alcohol-related Liver Disease: a Randomized Controlled Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age > 18 years
- Newly diagnosed alcohol-related liver disease within six months from baseline visit
- Liver stiffness above 8.0 kPa with 10 successful measurements and an interquartile range less than 30% by transient elastography
- Excessive alcohol consumption defined as >7 units/week for women and >14 units/week for men within the previous year
- Ability to understand the study purpose and provide informed oral and written consent
You will not qualify if you...
- Insufficient proficiency in Danish to participate in interviews and questionnaires
- Pregnancy
- Ongoing specialized alcohol use disorder treatment (self-help groups and counseling by general practitioners do not count)
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Department of Medicine, Zealand University Hospital
Køge, Køge, Denmark, 4600
Actively Recruiting
Research Team
E
Emil B B Fromberg, Cand.scient.san
CONTACT
G
Gro Askgaard, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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