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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

221 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-15

Study Completion Date

2029-04-01

Brief Summary

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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.

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Detailed Description

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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

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Liver Diseases, Alcoholic Alcohol Use Disorder Treatment Adherence Alcoholism Liver Disease; Alcohol-Related

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

There is follow-up for each individual participant conducted by personnel blinded to the randomization and consisting of: 1) telephone contact with interview about alcohol consumption using the time-line follow-back method conducted at three time points after 1, 3 and 6 months, 2) measurement of phosphatidyl ethanol after 6 months, and 3) electronic health records from hospital and alcohol treatment facility after 6 months.

Use of hypothesis blinding for patients about the study aim. Usual care providers in the hospital such as physicians and nurses will not see any description of AUD treatment in the medical charts.

Analyses will be performed in a blinded data set with treatment allocation labeled "A" and "B". Prior to this, the statistical analysis plan will be completed, signed, and uploaded at clinicaltrials.gov, and the data set will be locked. Unblinding will not occur until all analyses are performed (expected autumn 2028).

Study Groups

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Standard care group

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention group

Patients randomized to the intervention group.

Group Type EXPERIMENTAL

Offer of specialized alcohol use disorder treatment in the hepatology clinic

Intervention Type 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.

Interventions

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Offer of specialized alcohol use disorder treatment in the hepatology clinic

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No