ADDICTOlogical Intervention in LIVEr Transplantation Recipients

Status: Recruiting
Location: See all (17) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Aged 18 years or above

• Hospitalized for LT for AALD as primary or secondary indication

• Discharged from intensive care unit to hepatology or surgery wards

Locations
Other Locations
France
Besançon University Hospital
NOT_YET_RECRUITING
Besançon
Bordeaux University Hospital
NOT_YET_RECRUITING
Bordeaux
Clermont Ferrand University Hospital
RECRUITING
Clermont-ferrand
Dijon University Hospital
NOT_YET_RECRUITING
Dijon
Grenoble University Hospital
NOT_YET_RECRUITING
Grenoble
Lille University Hospital
NOT_YET_RECRUITING
Lille
Lyon University Hospital
RECRUITING
Lyon
Marseille University Hospital
NOT_YET_RECRUITING
Marseille
Montpellier University Hospital
RECRUITING
Montpellier
Nice University Hospital
NOT_YET_RECRUITING
Nice
APHP Mondor
NOT_YET_RECRUITING
Paris
APHP Paul Brousse
NOT_YET_RECRUITING
Paris
APHP Salpetrière
NOT_YET_RECRUITING
Paris
Rennes University Hospital
NOT_YET_RECRUITING
Rennes
Strasbourg University Hospital
RECRUITING
Strasbourg
Toulouse University Hospital
NOT_YET_RECRUITING
Toulouse
Tours University Hospital
NOT_YET_RECRUITING
Tours
Contact Information
Primary
Hélène DONNADIEU, MD, PhD
h-donnadieu@chu-montpellier.fr
0467337020
Time Frame
Start Date: 2024-11-21
Estimated Completion Date: 2028-09
Participants
Target number of participants: 720
Treatments
Experimental: Interventional group
Patients randomized into the interventional arm will participate in an addiction consultation during their hospital stay following LT. The participant's addiction treatment will be based on the number of risk factors identified.
No_intervention: Control group
Participants randomized into the control arm will benefit from routine LT follow-up organized by the doctors and/or surgeons of the LT center during the post-transplant follow-up period. Usually, the patients have monthly outpatient visit with their physician during the first year after LT, then bi-monthly during the second year. At present, each center has a very different way of supporting transplant recipients, there is no systematic follow-up by an addictologist. Routine care at each center will be identified before the study set up. The different centers refer patients only after return to alcohol use is perceived in routine consultation or identified through biological alcohol markers. In this case, the alcohol relapse event will be noted and patients will be transferred to the addictologic center.
Sponsors
Leads: University Hospital, Montpellier

This content was sourced from clinicaltrials.gov