Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06472973

ADDICTOlogical Intervention in LIVEr Transplantation Recipients

Led by University Hospital, Montpellier · Updated on 2025-12-03

720

Participants Needed

16

Research Sites

313 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

ADDICTOlogical Intervention in LIVEr Transplantation Recipients

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 18 years or above
  • Hospitalized for liver transplantation for Alcohol Associated Liver Disease as primary, secondary, or tertiary indication
  • Discharged from intensive care unit to hepatology or surgery wards
Not Eligible

You will not qualify if you...

  • Severe alcohol-associated hepatitis as the primary indication for liver transplantation
  • Unable to be followed up for 2 years after liver transplantation
  • Refusal or absence of informed consent
  • Not affiliated with the French national health insurance
  • Under legal protection, guardianship, or curatorship

AI-Screening

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Trial Site Locations

Total: 16 locations

1

Besançon University Hospital

Besançon, France

Actively Recruiting

2

Bordeaux University Hospital

Bordeaux, France

Actively Recruiting

3

Clermont Ferrand University Hospital

Clermont-Ferrand, France

Actively Recruiting

4

Dijon University Hospital

Dijon, France

Actively Recruiting

5

Lille University Hospital

Lille, France

Actively Recruiting

6

Lyon University Hospital

Lyon, France

Actively Recruiting

7

Marseille University Hospital

Marseille, France

Not Yet Recruiting

8

Montpellier University Hospital

Montpellier, France, 34000

Actively Recruiting

9

Nice University Hospital

Nice, France

Actively Recruiting

10

APHP Mondor

Paris, France

Actively Recruiting

11

APHP Paul Brousse

Paris, France

Actively Recruiting

12

APHP Salpetrière

Paris, France

Actively Recruiting

13

Rennes University Hospital

Rennes, France

Actively Recruiting

14

Strasbourg University Hospital

Strasbourg, France

Actively Recruiting

15

Toulouse University Hospital

Toulouse, France

Actively Recruiting

16

Tours University Hospital

Tours, France

Actively Recruiting

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Research Team

H

Hélène DONNADIEU, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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