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Addiction Intervention in Liver Transplantation Candidates (Addictolive)

Primary Purpose

Transplant; Failure, Liver, Addiction, Alcohol

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Addiction follow-up before and after liver transplantation
Sponsored by
University Hospital, Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Transplant; Failure, Liver focused on measuring Liver transplantation, Alcohol relapse, Biological markers of alcohol consumption, Addiction follow up

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of hepato-gastroenterology and liver transplantationRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Adults undergoing pre- liver transplant assessment

Arm Description

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).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
Addiction consult
Rate of patient complying with their appointment
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).
Caracterization of contraindicated patients
Rates and characteristics of patients with temporary and/or permanent addiction contraindication
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.
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.)
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.)

Full Information

First Posted
March 30, 2022
Last Updated
August 1, 2022
Sponsor
University Hospital, Montpellier
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1. Study Identification

Unique Protocol Identification Number
NCT05322226
Brief Title
Addiction Intervention in Liver Transplantation Candidates
Acronym
Addictolive
Official Title
Evaluation of an Addiction Intervention in Candidates for Liver Transplantation
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 27, 2022 (Actual)
Primary Completion Date
January 1, 2025 (Anticipated)
Study Completion Date
May 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Transplant; Failure, Liver, Addiction, Alcohol
Keywords
Liver transplantation, Alcohol relapse, Biological markers of alcohol consumption, Addiction follow up

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
130 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Adults undergoing pre- liver transplant assessment
Arm Type
Other
Arm Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Addiction follow-up before and after liver transplantation
Intervention Description
Addiction consult and follow-up
Primary Outcome Measure Information:
Title
Rate of liver transplant patients with sustained alcohol relapse one year after liver transplant
Description
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
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Description of addictological means implemented during follow-up.
Description
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.
Time Frame
1 year
Title
Addiction consult
Description
Rate of patient complying with their appointment
Time Frame
1 year
Title
Addiction consult following biology results
Description
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).
Time Frame
1 year
Title
Caracterization of contraindicated patients
Description
Rates and characteristics of patients with temporary and/or permanent addiction contraindication
Time Frame
1 year
Title
Rate of transplanted patients with tobacco and other psycoactive substance consumption during the first year after liver transplant
Description
Smoking cessation is defined declaratively and using an expired CO test (< 6.5 ppm). Psychoactive substance consumption is declarative.
Time Frame
Every 3 months during 1 year
Title
Description of urinary marker of alcohol consumption.
Description
Urinary Ethylglucuronid (sensitiviy of 62-89% and specificity of 93-99% for alcohol absoption within 30 to 80 hours before urinary test.)
Time Frame
Every 3 months during 1 year
Title
Description of blood marker of alcohol consumption.
Description
Blood phosphatidylethanol (sensitivity of 90-99% and specificity of 100% for alcohol absorption within 2 to 6 weeks before blood test.)
Time Frame
Every 3 months during 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Helene Donnadieu, MH PD
Phone
+33467337020
Email
h-donnadieu_rigole@chu-montpellier.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helene Donnadieu, MH PD
Organizational Affiliation
Montpellier University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of hepato-gastroenterology and liver transplantation
City
Montpellier
State/Province
Occitanie
ZIP/Postal Code
34090
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Georges-Philippe Pageaux

12. IPD Sharing Statement

Learn more about this trial

Addiction Intervention in Liver Transplantation Candidates

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