Actively Recruiting
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
Eligibility Criteria
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
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
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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