ADDICTOlogical Intervention in LIVEr Transplantation Recipients

NCT06472973 | Recruiting

• 2 other identifiers: RECHMPL23_03992023-A02801-44
• Study Type: interventional
• Target: 720
• Locations: 1 country
• Sites: 16

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.

Conditions

Alcohol Associated Liver Disease; Liver Transplantation

Keywords

Liver transplantation; Addiction follow-up; Alcohol relapse; Survival

Outcome Measures

Primary Outcomes (1)

• Time to return to alcohol use

  Time to return to alcohol use is defined by the time between discharge from Liver Transplantation (LT) hospitalization and alcohol relapse,it includes either: * Severe relapse: alcohol intake of at least 4 units per day for men and 3 per day for women for at least 100 days; * Regular relapse: no more than 21 units a week for men, 14 units a week for women, at least 10 times a month; Alcohol consumption will be collected using the alcohol timeline follow back (TLFB), the assessor will be blinded to the participant's arm allocation. TLFB is a calandar used to asses the participant's alcohol intake, it evaluates their daily drinking and provides a report of their drinking pattern over a given time period. The first TLFB assessment will be carried out one month after discharge from LT hospitalization, then every 2 months up to 2 years after discharge from LT hospitalization.

  During 2 years after discharge from Liver transplantation hospitalization

Secondary Outcomes (10)

• Return to alcohol use of the slip type

  During 2 years after discharge from Liver transplantation hospitalization

• Tobacco use

  During 2 years after discharge from Liver transplantation hospitalization

• Other psychoactive substances use

  During 2 years after discharge from Liver transplantation hospitalization

• Addiction therapies

  During 2 years after discharge from Liver transplantation hospitalization

• Major significant clinical events

  During 2 years after discharge from Liver transplantation hospitalization

Study Arms (2)

Interventional group

EXPERIMENTAL

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.

Other: Post-transplant addiction intervention

Control group

NO INTERVENTION

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.

Interventions

Post-transplant addiction intervention OTHER

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.

Interventional group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (16)

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, 34000, 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 Officials

• Hélène DONNADIEU, MD, PhD

  University Hospital, Montpellier

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hélène DONNADIEU, MD, PhD

CONTACT

0467337020; h-donnadieu@chu-montpellier.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2024
• First Posted: June 25, 2024
• Study Start: November 21, 2024
• Primary Completion (Estimated): November 21, 2028
• Study Completion (Estimated): November 21, 2030
• Last Updated: December 3, 2025

Record last verified: 2025-11

Locations

FR (16)