NCT06472973 ADDICTOlogical Intervention in LIVEr Transplantation Recipients
| NCT ID | NCT06472973 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Montpellier |
| Condition | Alcohol Associated Liver Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 720 participants |
| Start Date | 2024-11-21 |
| Primary Completion | 2028-11-21 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 720 participants in total. It began in 2024-11-21 with a primary completion date of 2028-11-21.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * Aged 18 years or above * Hospitalized for LT for AALD as primary, secondary or tertiary indication * Discharged from intensive care unit to hepatology or surgery wards Exclusion Criteria: * Severe alcohol-associated hepatitis as primary indication for liver transplantation * Impossibility of patient follow up over the next 2 years * General criteria: * Refusal or absence of informed consent, * Non-affiliation to the French national health insurance, * Persons placed under legal protection, guardianship or curatorship
Contact & Investigator
Hélène DONNADIEU, MD, PhD
PRINCIPAL INVESTIGATOR
University Hospital, Montpellier
Frequently Asked Questions
Who can join the NCT06472973 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Alcohol Associated Liver Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06472973 currently recruiting?
Yes, NCT06472973 is actively recruiting participants. Contact the research team at h-donnadieu@chu-montpellier.fr for enrollment information.
Where is the NCT06472973 trial being conducted?
This trial is being conducted at Besançon, France, Bordeaux, France, Clermont-Ferrand, France, Dijon, France and 11 additional locations.
Who is sponsoring the NCT06472973 clinical trial?
NCT06472973 is sponsored by University Hospital, Montpellier. The principal investigator is Hélène DONNADIEU, MD, PhD at University Hospital, Montpellier. The trial plans to enroll 720 participants.