Addiction Intervention in Liver Transplantation Candidates (Addictolive)

Evaluation of an Addiction Intervention in Candidates for Liver Transplantation

Addiction care is "a la carte treatment", adapted to the motivation and time constrains of users. Thus, various types of psychotherapeutic follow-up can be considered, different addictolytic medications or opioid maintenance therapies can be offered during treatment and hospitalization must be adaptable. In liver transplantation (LT), sustained alcohol relapse is a critical issue because it increases medium and long-term morbidity and mortality. In recent years, the issue of severe acute alcoholic hepatitis as an indication for LT has necessitated increased focus on appropriate alcohol monitoring around liver transplantation. Previously, alcohol consumption in pre- and post-LT period was mainly self-reported. More recently, the biological markers of excessive alcohol consumption have been validated in liver disease and can play a role in liver transplant recipients follow-up.

The investigator hypothesize that standardized targeted addiction monitoring of LT patients decreases the rates of sustained alcohol relapse one year post liver transplantation.

Study Overview

• Status: Active, not recruiting
• Conditions: Transplant; Failure, Liver; Addiction, Alcohol
• Intervention / Treatment: Behavioral: Addiction follow-up before and after liver transplantation

Detailed Description

The main objective of this study is to identify the impact of a targeted addiction monitoring of pre- and post-LT patients on rates of sustained alcohol relapse, one year after LT at the Liver Transplant Unit of the University Hospital of Montpellier. The secondary objectives are: (i) to precisely detail all the addiction treatments (medications, psychotherapy types and specific hospitalization) implemented during this follow-up, (ii) to assess the impact of targeted addiction treatment on the tobacco use and other psychoactive substances (PS) consumption rates , (iii) to quantify LT patients' acceptability of referral to addiction-related treatment and care, (iv) to assess the relevance of biological markers of excessive alcohol consumption during pre- and post-LT period.

The investigator will conduct an A'Hern Single-stage Phase II monocentric interventional trial.

All patients undergoing assessment for LT in Montpellier's Liver Transplant Unit will be consecutively included during their first systematic consultation with the addiction specialist. During this interview, the risk of alcohol relapse will be assessed and targeted addiction follow-up will be planned. Starting from the registration on the national waiting list, biological markers of excessive alcohol consumption will be performed every three months and the patient will be referred to the addiction specialist if the results are positive. After LT these evaluations will continue every three months for one year and patients will be referred for addiction treatment as needed. All participants will have a final interview with an addiction specialist one year post LT.

Using the single-stage A'Hern design, a sample size of 65 LT patients is required to distinguish between a maximum futility proportion of 26% of sustained relapses and a minimum efficacy proportion of 13%, with a one-sided significance level of 0,047 and a power of 82,4%. Based on these criteria, the number of patients with sustained relapse must be at least 10 for the proposed treatment to be deemed effective.

Each patient's socio-demographic, medical, hepatological and addiction data will be collected at baseline. All data concerning each patient's targeted addiction follow-ups, biological markers, rates of sustained alcohol relapse, tobacco and PS consumption rates will be noted during the first year after LT.

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Occitanie
    • Montpellier, Occitanie, France, 34090
      • Department of hepato-gastroenterology and liver transplantation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• all adults undergoing pre-transplant assessment in the Liver Transplantation Unit of University Hospital of Montpellier, providing oral informed consent.

Exclusion Criteria:

• Patients under protection of justice or unable to receive a clear information.
• Exclusion period determined by previous study
• Pregnent women or breastfeeding
• Patient under guardianship or curatorship
• Not affiliated to french social security

Removal of subjects from study criteria:

• not registered on the liver transplant waiting-list or not transplanted during the study period
• Liver transplantation prior to visit 1

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Adults undergoing pre- liver transplant assessment; All patients included in the study will have blood and urinary test from their registration on the transplant list and during their classic follow-up with their hepatologist for 12 months to quantify the biological markers of alcoholism (every 3 months). Additional tubes and urine will be collected in order to measure these markers (urinary ethylglucuronide and blood phosphatidylethanol).

Behavioral: Addiction follow-up before and after liver transplantation; Addiction consult and follow-up

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of liver transplant patients with sustained alcohol relapse one year after liver transplant	The rate is defined by at least one positive alcohol marker and a daily amount of alcohol exceeding 3 (women) or 4 (men) drinks per day with the notion of loss of control recorded during addiction interview	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Description of addictological means implemented during follow-up.	Addiction physician will choose medications, psychotherapeutic interventions, and hospitalization when appropriate. Rate of patients in pre-transplantation evaluated at low risk and with severe relapse at 1 year post liver transplant.	1 year
Addiction consult	Rate of patient complying with their appointment	1 year
Addiction consult following biology results	Proportion of follow-up addiction consultations having been guided, according to the opinion of the clinician, by the results of the biological markers (and not only by the self-declaration of consumption).	1 year
Caracterization of contraindicated patients	Rates and characteristics of patients with temporary and/or permanent addiction contraindication	1 year
Rate of transplanted patients with tobacco and other psycoactive substance consumption during the first year after liver transplant	Smoking cessation is defined declaratively and using an expired CO test (< 6.5 ppm). Psychoactive substance consumption is declarative.	Every 3 months during 1 year
Description of urinary marker of alcohol consumption.	Urinary Ethylglucuronid (sensitiviy of 62-89% and specificity of 93-99% for alcohol absoption within 30 to 80 hours before urinary test.)	Every 3 months during 1 year
Description of blood marker of alcohol consumption.	Blood phosphatidylethanol (sensitivity of 90-99% and specificity of 100% for alcohol absorption within 2 to 6 weeks before blood test.)	Every 3 months during 1 year

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Investigators: Principal Investigator: Helene Donnadieu, MH PD, Montpellier University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 27, 2022
• Primary Completion (Actual): September 26, 2024
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: March 30, 2022
• First Submitted That Met QC Criteria: April 8, 2022
• First Posted (Actual): April 11, 2022

Study Record Updates

• Last Update Posted (Estimated): December 3, 2025
• Last Update Submitted That Met QC Criteria: November 26, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Liver transplantation; Alcohol relapse; Biological markers of alcohol consumption; Addiction follow up
• Additional Relevant MeSH Terms: Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Alcohol-Related Disorders; Alcoholism
• Other Study ID Numbers: RECHMPL21_0516

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No