Department of hepato-gastroenterology and liver transplantation
Montpellier, Occitanie, 34090, France
NCT Number: NCT05322226
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.
This study is active but is not currently recruiting participants.
Notify Me18 year–70 year
All sexes
Interventional
Not applicable
Montpellier, Occitanie, 34090, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Removal of subjects from study criteria:
Addiction consult and follow-up
Time frame: 1 year
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
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
Rate of patient complying with their appointment
Time frame: 1 year
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
Rates and characteristics of patients with temporary and/or permanent addiction contraindication
Time frame: Every 3 months during 1 year
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
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
Blood phosphatidylethanol (sensitivity of 90-99% and specificity of 100% for alcohol absorption within 2 to 6 weeks before blood test.)
University Hospital, Montpellier
Other
Evaluation of an Addiction Intervention in Candidates for Liver Transplantation
Acronym: Addictolive
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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