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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorZealand University Hospital

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

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

    Behavioral

    Patients 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

221 Participants
are divided into 2 treatment groups
Group A: Standard care groupNo intervention 0 interventions
Group B: Intervention groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
6 months after baseline

Secondary outcomes

1

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.

Time frame
3 months after baseline
2

Rate of AUD treatment

Any treatment for alcohol use disorder after 6 and 12 months

Time frame
6 and 12 months after baseline
3

Rate of individuel AUD treatment

Any individuel treatment for alcohol use disorder after 6 and 12 months

Time frame
6 and 12 months after baseline
4

Rate of AUD treatment

Number of received sessions of treatment for alcohol use disorder after 6 and 12 months

Time frame
6 and 12 months from baseline

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Zealand University Hospital

Lead sponsor

Center for Clinical Research and Prevention

Collaborator

Novavi Outpatient Clinics

Collaborator