Intervention for liver transplant recipients with alcohol use disorder
ADDICTOlogical Intervention in LIVEr Transplantation Recipients
This study tests a new support program for liver transplant patients with a history of alcohol problems to see if it helps them avoid drinking again and live longer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 720 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Montpellier Academic / other |
| Locations | 16 sites (Besançon and 15 other locations) |
| Trial ID | NCT06472973 on ClinicalTrials.gov |
What this trial studies
This clinical trial focuses on liver transplantation recipients who have a history of alcohol use disorder. It aims to implement a post-transplant addiction intervention to reduce the risk of alcohol relapse, which can significantly impair long-term survival. The study will involve a transdisciplinary approach, integrating addiction specialists into the liver transplant program to provide comprehensive care. By addressing the behavioral aspects of alcohol use, the trial seeks to improve patient outcomes and survival rates after liver transplantation.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who are hospitalized for liver transplantation due to alcohol-associated liver disease.
Not a fit: Patients who have had a longitudinal pre-transplant addiction follow-up or severe alcohol-associated hepatitis as their primary indication for transplantation may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly reduce alcohol relapse rates and improve long-term survival for liver transplant recipients.
How similar studies have performed: Previous studies have shown varying success in managing alcohol relapse in liver transplant recipients, but this specific integrated approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Besançon and 15 other locations
- Besançon University Hospital — Besançon, France (Recruiting)
- Bordeaux University Hospital — Bordeaux, France (Recruiting)
- Clermont Ferrand University Hospital — Clermont-Ferrand, France (Recruiting)
- Dijon University Hospital — Dijon, France (Recruiting)
- Lille University Hospital — Lille, France (Recruiting)
- Lyon University Hospital — Lyon, France (Recruiting)
- Marseille University Hospital — Marseille, France (Not_yet_recruiting)
- Montpellier University Hospital — Montpellier, France (Recruiting)
- Nice University Hospital — Nice, France (Recruiting)
- APHP Mondor — Paris, France (Recruiting)
- APHP Paul Brousse — Paris, France (Recruiting)
- APHP Salpetrière — Paris, France (Recruiting)
- Rennes University Hospital — Rennes, France (Recruiting)
- Strasbourg University Hospital — Strasbourg, France (Recruiting)
- Toulouse University Hospital — Toulouse, France (Recruiting)
- Tours University Hospital — Tours, France (Recruiting)
Study contacts
- Principal investigator: Hélène DONNADIEU, MD, PhD — University Hospital, Montpellier
- Study coordinator: Hélène DONNADIEU, MD, PhD
- Email: h-donnadieu@chu-montpellier.fr
- Phone: 0467337020
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.