NCT05322226

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
8mo left

Started Jul 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress85%
Jul 2022Dec 2026

First Submitted

Initial submission to the registry

March 30, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 11, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

July 27, 2022

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 26, 2024

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected
Last Updated

December 3, 2025

Status Verified

November 1, 2025

Enrollment Period

2.2 years

First QC Date

March 30, 2022

Last Update Submit

November 26, 2025

Conditions

Transplant; Failure, LiverAddiction, Alcohol

Keywords

Liver transplantationAlcohol relapseBiological markers of alcohol consumptionAddiction follow up

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Description of addictological means implemented during follow-up.

    1 year

  • Addiction consult

    1 year

  • Addiction consult following biology results

    1 year

  • Caracterization of contraindicated patients

    1 year

  • Rate of transplanted patients with tobacco and other psycoactive substance consumption during the first year after liver transplant

    Every 3 months during 1 year

  • +2 more secondary outcomes

Study Arms (1)

Adults undergoing pre- liver transplant assessment

OTHER

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

Interventions

Addiction follow-up before and after liver transplantationBEHAVIORAL

Addiction consult and follow-up

Adults undergoing pre- liver transplant assessment

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Patients under protection of justice or unable to receive a clear information.
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of hepato-gastroenterology and liver transplantation

Montpellier, Occitanie, 34090, France

Location

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Helene Donnadieu, MH PD

    Montpellier University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 30, 2022

First Posted

April 11, 2022

Study Start

July 27, 2022

Primary Completion

September 26, 2024

Study Completion (Estimated)

December 31, 2026

Last Updated

December 3, 2025

Record last verified: 2025-11

Locations

FR(1)