ADDICTOlogical Intervention in LIVEr Transplantation Recipients

ConditionsAlcohol Associated Liver Disease Liver Transplantation

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorUniversity Hospital, Montpellier

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Severe alcohol-associated hepatitis as primary indication for liver transplantation

Impossibility of patient follow up over the next 2 years

Refusal or absence of informed consent,

Non-affiliation to the French national health insurance,

Trial design

Design model

Parallel

Treatments tested in this trial

Post-transplant addiction intervention
Other 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.

Treatment groups

720 Participants

are divided into 2 treatment groups

Group A: Interventional groupExperimental treatment 1 intervention

Group B: Control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

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.

Time frame