About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
Offer of specialized alcohol use disorder treatment in the hepatology clinic
BehavioralPatients are offered specialized alcohol use disorder treatment in the hepatology clinic by an experienced AUD therapist from the AUD facility. Also medical AUD treatments will be offered to support abstinence.
Treatment groups
Trial outcomes
Primary outcomes
Self-reported alcohol abstinence in the last 30 days at 6 months followup in combination with phosphatidylethanol level at 6 months
Self-reported alcohol abstinence (defined as zero consumption of alcohol) throughout the last 30 days assessed after 6 months assessed by the timeline followback method (questionnaire) and review of medical charts and measurement of phosphatidylethanol at 6 months
Secondary outcomes
Self-reported alcohol abstinence in the last 30 days at 3 months followup
Self-reported alcohol abstinence (defined as zero consumption of alcohol) throughout the last 30 days assessed after 3 months and no indications of alcohol use in medical charts.
Rate of AUD treatment
Any treatment for alcohol use disorder after 6 and 12 months
Rate of individuel AUD treatment
Any individuel treatment for alcohol use disorder after 6 and 12 months
Rate of AUD treatment
Number of received sessions of treatment for alcohol use disorder after 6 and 12 months
Sponsors and contacts
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Zealand University Hospital
Lead sponsor
Center for Clinical Research and Prevention
Collaborator
Novavi Outpatient Clinics
Collaborator