Actively Recruiting
Alcohol Misuse Treatment Delivered in the Hepatology Clinic 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
N/A
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
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.
CONDITIONS
Brief 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 of baseline visit
- Liver stiffness above 8.0 kPa with 10 successful measurements and less than 30% interquartile range by transient elastography
- Excessive alcohol consumption of >7 units/week for women or >14 units/week for men in 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 general practitioner counselling do not count)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 to 12 months
Participants randomized to the intervention group receive specialized alcohol use disorder treatment in the hepatology clinic by an experienced AUD therapist, in addition to standard care. Participants in the standard care group receive education on alcohol-related liver disease and encouragement to abstain from alcohol use.
Visits scheduled according to treatment plan in the hepatology clinic
Duration - Up to 3 years after baseline
Participants are followed up to assess alcohol abstinence, treatment rates, liver disease progression, and other health outcomes.
Follow-up visits at approximately 3, 6, 12 months, and annually up to 3 years
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
G
Gro Askgaard, PhD
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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