Liver Diseases, AlcoholicNCT06493773
Alcohol Misuse Treatment to Patients Newly Diagnosed With Alcohol-related Liver Disease: a Randomized Controlled Trial
A study testing Offer of specialized alcohol use disorder treatment in the hepatology clinic in people with Liver Diseases, Alcoholic and Alcohol Use Disorder, run by Zealand University Hospital at 1 site in Denmark.
Trial 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 randomized controlled superiority trial with parallel group design, hypothesis blinding and blinded outcome assessment… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Diseases, Alcoholic, Alcohol Use Disorder, Treatment Adherence
- What is being tested?
- Offer of specialized alcohol use disorder treatment in the hepatology clinic
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 221 participants
- Where
- 1 siteDenmark
- Study dates
- 15 Nov 2025to 1 Apr 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Department of Medicine, Zealand University Hospital
Køge, Køge, 4600
Gro Askgaard, gask@regionsjaelland.dk
About this study
Official title: Alcohol Misuse Treatment Delivered in the Hepatology Clinic to Patients Newly Diagnosed With Alcohol-related Liver Disease: a Randomized Controlled 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.
Read the 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 patients to increase the proportion that are abstaining from alcohol after 6 months compared to standard care. The study will be embedded in an existing observational cohort from which already included participants will be used as controls in the RCT (n = 89). Please see Figure 1 for the flow of participants in the study. From november, 2025, the investigators will start to randomize eligible participants.
Randomization will take place in connection with the first visit in the observational cohort study. Study participants randomized as controls will receive standard care through their treating physicians, which consists of individualized education on the nature of ALD as well as encouragement of alcohol use cessation.
Patients in the intervention group will receive standard care in addition to an offer of AUD treatment in the hepatology clinic.
- Conditions
- Liver Diseases, Alcoholic, Alcohol Use Disorder, Treatment Adherence, Alcoholism, Liver Disease; Alcohol-Related
- Being tested
- Offer of specialized alcohol use disorder treatment in the hepatology clinic
- Keywords
- Alcoholic liver disease, Alcohol use disorder, Alcohol treatment, randomized clinical trial, hepatology clinic
- Medical subject headings
- Liver Diseases, Alcoholic, Alcoholism, Treatment Adherence and Compliance, Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Offer of specialized alcohol use disorder treatment in the hepatology clinicBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard care group | No intervention | Patients randomized to standard care will receive standard supporting care by their care providers, entailing education on the nature of alcohol-related liver disease and encouragement to abstain from alcohol use. |
| Intervention group | Experimental | Patients randomized to the intervention group. Receives: Behavioral: Offer of specialized alcohol use disorder treatment in the hepatology clinic |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months after baseline
Secondary outcomes (12)
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.
Measured: 3 months after baseline
Rate of AUD treatment
Any treatment for alcohol use disorder after 6 and 12 months
Measured: 6 and 12 months after baseline
Rate of individuel AUD treatment
Any individuel treatment for alcohol use disorder after 6 and 12 months
Measured: 6 and 12 months after baseline
Rate of AUD treatment
Number of received sessions of treatment for alcohol use disorder after 6 and 12 months
Measured: 6 and 12 months from baseline
Reduction in drinks per week
Reduction in drinks per week after 3, 6 and 12 months compared to baseline (yes or no)
Measured: 3, 6 and 12 months from baseline
Reduction in phosphatidylethanol
Reduction in phosphatidylethanol value at 6 and 12 months compared to baseline (yes or no)
Measured: 6 and 12 months from baseline
Complications from liver disease
Time to first decompensation event, which is defined as variceal haemorrhage, ascites grade 2 or worse, or hepatic encephalopathy West-Haven grade 2 or worse
Measured: 3 years from baseline
All-cause mortality
time to death
Measured: 3 years from baseline
Progression of liver disease
Progression in liver fibrosis grade assessed by transient elastography or progression to a worse Child-Pugh class (A to B or C and B to C
Measured: 3 years from baseline
Duration of AUD treatment
Duration of AUD treatment
Measured: 6 and 12 months from baseline
Group AUD treatment sessions
Amount of group AUD treatment sessions
Measured: 6 and 12 months from baseline
Self-reported abstinence last 30 days after 12 months and phosphatidylethanol level after 12 months
Self-reported alcohol abstinence last 30 days by 12 months assessed by the timeline followback method (questionnaire) and review of electronic medical records in combination with measured phosphatidylethanol level.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2024
- Study start15 Nov 2025 (estimated)
- Primary completion1 Apr 2029 (estimated)
- Study completion1 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver Diseases, AlcoholicStudies of the same condition, open and under way.
- More trials run by Zealand University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 221 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zealand University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Center for Clinical Research and Prevention, Novavi Outpatient Clinics
- Responsible party
- Sponsor
- Investigators
- Lone G Madsen, PhD, Study chair, Zealand University Hospital, Koege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06493773
- Sponsor's protocol ID
- SJ-895
- Status last verified
- Nov 2025
- First submitted
- 28 Jun 2024
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Because of the relatively low number of patients, data are considered highly sensitive and cannot allow sharing
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alcohol Misuse Treatment Delivered in the Hepatology Clinic to Patients Newly Diagnosed With Alcohol-related Liver Disease: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06493773
- Acronym / sponsor ID
- SJ-895
- Conditions
- Liver Diseases, Alcoholic, Alcohol Use Disorder, Treatment Adherence, Alcoholism, Liver Disease; Alcohol-Related
- Keywords
- Alcoholic liver disease, Alcohol use disorder, Alcohol treatment, randomized clinical trial, hepatology clinic
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 221 participants (estimated)
- Lead sponsor
- Zealand University HospitalUniversity, hospital or other
- Collaborators
- Center for Clinical Research and Prevention, Novavi Outpatient Clinics
- Study start
- 15 Nov 2025 (estimated)
- Primary completion
- 1 Apr 2029 (estimated)
- Study completion
- 1 Apr 2029 (estimated)
- First posted
- 10 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 patients to increase the proportion that are abstaining from alcohol after 6 months compared to standard care. The study will be embedded in an existing observational cohort from which already included participants will be used as controls in the RCT (n = 89). Please see Figure 1 for the flow of participants in the study. From november, 2025, the investigators will start to randomize eligible participants.
Randomization will take place in connection with the first visit in the observational cohort study. Study participants randomized as controls will receive standard care through their treating physicians, which consists of individualized education on the nature of ALD as well as encouragement of alcohol use cessation.
Patients in the intervention group will receive standard care in addition to an offer of AUD treatment in the hepatology clinic.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard care group | No intervention | –Patients randomized to standard care will receive standard supporting care by their care providers, entailing education on the nature of alcohol-related liver disease and encouragement to abstain from alcohol use. |
| Intervention group | Experimental | Behavioral: Offer of specialized alcohol use disorder treatment in the hepatology clinicPatients randomized to the intervention group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Offer of specialized alcohol use disorder treatment in the hepatology clinicPatients 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. | Behavioural | Intervention group |
Primary outcome
Self-reported alcohol abstinence in the last 30 days at 6 months followup in combination with phosphatidylethanol level at 6 months
Time frame: 6 months after baseline
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
12 secondary outcomes
Self-reported alcohol abstinence in the last 30 days at 3 months followup
Time frame: 3 months after baseline
Rate of AUD treatment
Time frame: 6 and 12 months after baseline
Rate of individuel AUD treatment
Time frame: 6 and 12 months after baseline
Rate of AUD treatment
Time frame: 6 and 12 months from baseline
Reduction in drinks per week
Time frame: 3, 6 and 12 months from baseline
Reduction in phosphatidylethanol
Time frame: 6 and 12 months from baseline
Complications from liver disease
Time frame: 3 years from baseline
All-cause mortality
Time frame: 3 years from baseline
Progression of liver disease
Time frame: 3 years from baseline
Duration of AUD treatment
Time frame: 6 and 12 months from baseline
Group AUD treatment sessions
Time frame: 6 and 12 months from baseline
Self-reported abstinence last 30 days after 12 months and phosphatidylethanol level after 12 months
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
- Individual participant dataSharing planned: No. Because of the relatively low number of patients, data are considered highly sensitive and cannot allow sharing
Related trials for Liver Diseases, Alcoholic
Not yet recruiting
Efficacy of Carnitine Complex in Improving Hepatic Steatosis in Potential Liver Donors
Hepatic Steatosis, Fatty Liver
Recruiting
NAFLD Clinical Care Pathway
NAFLD, MASLD
RecruitingPhase 3
Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD
RecruitingPhase 1
A Study of Efimosfermin Alfa in Adults With Hepatic Impairment
Non-alcoholic Fatty Liver Disease
RecruitingPhase 2
A Study to Investigate the Safety and Efficacy of Efimosfermin Alfa Compared With Placebo in Adult Participants With Alcohol-related Liver Disease (ALD)
Liver Diseases, Alcoholic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lone G Madsen, PhD study chair
Zealand University Hospital, Koege
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Offer of specialized alcohol use disorder treatment in the hepatology clinic in people with Liver Diseases, Alcoholic and Alcohol Use Disorder, run by Zealand University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emil B B Fromberg, Cand.scient.san (51184036 ext. +45, ebuf@regionsjaelland.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-reported alcohol abstinence in the last 30 days at 6 months followup in combination with phosphatidylethanol level at 6 months (time frame: 6 months after baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2025.