ADDICTOlogical Intervention in LIVEr Transplantation Recipients

Recruiting now · Not applicable

Conditions studied: Alcohol Associated Liver Disease, Liver Transplantation

In brief

Transplantation for end-stage-liver disease (ESLD) in the context of Alcohol-Associated Liver Disease (AALD) has been increasing and represents the main indication for Liver Transplantation (LT) in the world. Alcohol Use Disorder (AUD) is considered a brain chronic disease and requires a transdisciplinary approach that includes medical treatment and behavioral interventions. In the context of LT, alcohol relapse occurs in 26 % up to 50% of LT recipients. Among Liver transplant recipients for AALD, severe alcoholic relapse (defined as more than 3 alcoholic drinks per day for women and 4/day for men) after LT leads to impaired longterm survival due to recurrent alcoholic cirrhosis (RAC), cardiovascular events and de novo cancer. Several strategies have been developed to prevent alcohol relapse. After LT, integrating an addiction team into the LT program has been advocated by the latest guidelines in Europe and the United States, in order to bring the management of alcohol-use disorder (AUD) in transplantation units, through the association of psychosocial and pharmacological interventions previously reported in AALD. However, those guidelines were based on descriptive studies, and the effect of this management needs to be confirmed through a randomized, controlled, multicenter study, involving centers that still do not include an addiction team in their LT programs. This study will therefore assess prospectively and comparatively the impact of an addiction intervention after LT on return to alcohol use rates. We hypothesize that standardized targeted addiction monitoring of Liver Transplant recipients decreases the rates of alcohol relapse two years post-liver transplantation.

Key facts

Study ID

NCT06472973

Run by

University Hospital, Montpellier

People needed

720

Starts

2024-11-21

Expected to finish

2030-11-21

Last updated by the study team

2026-06-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Aged 18 years or above
• Hospitalized for LT for AALD as primary, secondary or tertiary indication
• Discharged from intensive care unit to hepatology or surgery wards

You may not qualify if…

• Severe alcohol-associated hepatitis as primary indication for liver transplantation
• Impossibility of patient follow up over the next 2 years
• General criteria:
• Refusal or absence of informed consent,
• Non-affiliation to the French national health insurance,
• Persons placed under legal protection, guardianship or curatorship

Where it is running

• Besançon University Hospital — Besançon, France (enrolling)
• Bordeaux University Hospital — Bordeaux, France (enrolling)
• Clermont Ferrand University Hospital — Clermont-Ferrand, France (enrolling)
• Dijon University Hospital — Dijon, France (enrolling)
• Lille University Hospital — Lille, France (enrolling)
• Lyon University Hospital — Lyon, France (enrolling)
• Marseille University Hospital — Marseille, France (enrolling)
• Montpellier University Hospital — Montpellier, France (enrolling)
• Nice University Hospital — Nice, France (enrolling)
• APHP Mondor — Paris, France (enrolling)
• APHP Paul Brousse — Paris, France (enrolling)
• APHP Salpetrière — Paris, France (enrolling)
• Rennes University Hospital — Rennes, France (enrolling)
• Strasbourg University Hospital — Strasbourg, France (enrolling)
• Toulouse University Hospital — Toulouse, France (enrolling)
• Tours University Hospital — Tours, France (enrolling)

Full record on ClinicalTrials.gov

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