Actively Recruiting
ADDICTOlogical Intervention in LIVEr Transplantation Recipients
Led by University Hospital, Montpellier · Updated on 2025-12-03
720
Participants Needed
16
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the impact of addiction-focused interventions on liver transplant recipients with Alcohol-Associated Liver Disease (AALD). This trial investigates whether targeted addiction monitoring after liver transplantation can reduce alcohol relapse rates, which affect long-term survival and health outcomes. It addresses the high relapse risk post-transplant and aims to improve management by comparing standard care with specialized addiction support. Participants are randomly assigned to one of two groups: an interventional group receiving specialized addiction consultations using the BRENDA method, where risk factors for relapse guide the intensity of follow-up and possible pharmacological treatment; and a control group receiving routine liver transplant follow-up without systematic addiction specialist involvement. The intervention includes outpatient motivational interviews every 4 weeks or consultations every 6 months, with hospitalizations if relapse risk is high. During the study, participants are monitored for two years following their liver transplantation hospital discharge. Researchers assess alcohol relapse timing and severity, tobacco and other substance use, addiction treatments received, clinical events, liver function tests, biomarkers of alcohol consumption, liver fibrosis, cognitive changes, and mortality related to alcohol. Follow-up visits and evaluations occur regularly to track these outcomes and the effectiveness of the addiction intervention.
CONDITIONS
Brief 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 main reason for liver transplantation
- Unable to be followed up for the next 2 years
- 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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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 2 years after discharge from liver transplantation hospitalization
Participants who receive a liver transplant for Alcohol-Associated Liver Disease will either receive targeted addiction specialist interventions or routine transplant center follow-up to help prevent alcohol relapse.
Monthly outpatient visits during the first year and bi-monthly visits during the second year for control group; addiction consultations at least every 4 weeks or every 6 months depending on risk factors for interventional group
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
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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