Clinical trial NCT05322226: Addiction Intervention in Liver Transplantation Candidates
Official title: Evaluation of an Addiction Intervention in Candidates for Liver Transplantation
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Transplant; Failure, Liver
Addiction, Alcohol
Keywords: Liver transplantation
Alcohol relapse
Biological markers of alcohol consumption
Addiction follow up
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2022-04-11
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of liver transplant patients with sustained alcohol relapse one year after liver transplant
timeFrame: 1 year
Secondary outcomes:
measure: Description of addictological means implemented during follow-up.
timeFrame: 1 year
measure: Addiction consult
timeFrame: 1 year
measure: Addiction consult following biology results
timeFrame: 1 year
measure: Caracterization of contraindicated patients
timeFrame: 1 year
measure: Rate of transplanted patients with tobacco and other psycoactive substance consumption during the first year after liver transplant
timeFrame: Every 3 months during 1 year
measure: Description of urinary marker of alcohol consumption.
timeFrame: Every 3 months during 1 year
measure: Description of blood marker of alcohol consumption.
timeFrame: Every 3 months during 1 year
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Department of hepato-gastroenterology and liver transplantation
state: Occitanie
Study officials:
affiliation: Montpellier University Hospital
name: Helene Donnadieu, MH PD
role: PRINCIPAL_INVESTIGATOR
References: