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RECRUITING
NCT06472973
NA

ADDICTOlogical Intervention in LIVEr Transplantation Recipients

Sponsor: University Hospital, Montpellier

View on ClinicalTrials.gov

Summary

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 Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

720

Start Date

2024-11-21

Completion Date

2030-11-21

Last Updated

2025-12-03

Healthy Volunteers

No

Interventions

OTHER

Post-transplant addiction intervention

The first addiction consultation will be conducted using the BRENDA method which allows the addiction specialist to carry out a psychosocial assessment, to entrust the results of this assessment to the participant, to answer their questions and to evaluate their reactions. Risk factors for alcohol relapse will be collected: social determinants, male gender, psychiatric comorbidities, duration of alcohol abstinence before LT(≥ or \< 6 months) and young age (\< 40 years). If the addiction specialist notes the presence of at least 3 risk factors for alcohol relapse, targeted addiction follow-up will be proposed to the participant including outpatient consultations with motivational interview at least every 4 weeks +/- pharmacological treatment of alcohol use disorder.In case of alcohol relapse or a period of high vulnerability to relapse, specific hospitalizations can be scheduled. If the participant has \<3 risk factors, an addictology consultation every 6 months at most will be proposed.

Locations (16)

Besançon University Hospital

Besançon, France

Bordeaux University Hospital

Bordeaux, France

Clermont Ferrand University Hospital

Clermont-Ferrand, France

Dijon University Hospital

Dijon, France

Lille University Hospital

Lille, France

Lyon University Hospital

Lyon, France

Marseille University Hospital

Marseille, France

Montpellier University Hospital

Montpellier, France

Nice University Hospital

Nice, France

APHP Mondor

Paris, France

APHP Paul Brousse

Paris, France

APHP Salpetrière

Paris, France

Rennes University Hospital

Rennes, France

Strasbourg University Hospital

Strasbourg, France

Toulouse University Hospital

Toulouse, France

Tours University Hospital

Tours, France