Addiction Intervention in Liver Transplantation Candidates

Addiction, Alcohol Clinical Trial

— Addictolive  

Official title:

Evaluation of an Addiction Intervention in Candidates for Liver Transplantation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05322226
• Other study ID #: RECHMPL21_0516_UF7932
• Status: Recruiting
• Phase: N/A
• Start date: July 27, 2022
• Est. completion date: October 27, 2027

Study information

• Verified date: May 2024
• Source: University Hospital, Montpellier
• Contact: Helene Donnadieu, MH PD
• Phone: +33467337020
• Email: h-donnadieu_rigole[@]chu-montpellier.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. completion date: October 27, 2027
• Est. primary completion date: January 27, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Addiction, Alcohol
• Alcoholism
• Behavior, Addictive
• Transplant; Failure, Liver

Intervention

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

Locations

Country	Name	City	State
France	Department of hepato-gastroenterology and liver transplantation	Montpellier	Occitanie

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Addiction consult	Rate of patient complying with their appointment	1 year
Secondary	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
Secondary	Caracterization of contraindicated patients	Rates and characteristics of patients with temporary and/or permanent addiction contraindication	1 year
Secondary	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
Secondary	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
Secondary	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