Addiction, Alcohol Clinical Trial
— AddictoliveOfficial title:
Evaluation of an Addiction Intervention in Candidates for Liver Transplantation
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.
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 |
Country | Name | City | State |
---|---|---|---|
France | Department of hepato-gastroenterology and liver transplantation | Montpellier | Occitanie |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Montpellier |
France,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04876443 -
Impact of COVID-19 Outbreak on the Alcohol Consumption in Patients With Alcohol-related Liver Disease (ICoLD)
|
||
Recruiting |
NCT05042180 -
Virtual Reality-Assisted Cognitive Behavioral Therapy for Alcohol Dependence (CRAVR)
|
Phase 2 | |
Recruiting |
NCT04599270 -
Efficiency of Prevention Program Dedicated to Addictive Behaviors (PREVENTURE) of Vulnerable Teenagers
|
N/A | |
Recruiting |
NCT05361603 -
Acceptability of Simultaneous Screening for Viral Hepatitis B, C and HIV Among Drug Users in Non-conventional Structures
|
||
Recruiting |
NCT04990765 -
Virtual Reality-Assisted Cognitive Behavioral Therapy for Alcohol Dependence (CRAVR-Pilot)
|
Phase 2 | |
Recruiting |
NCT05730504 -
Evaluating the Effectiveness of Mobile Self-guided Psychological Interventions to Reduce Relapse in Substance Use Disorder
|
N/A | |
Recruiting |
NCT05434416 -
The Efficacy of a Mobile Application in Reducing Craving and Lapse Risk in Alcohol and Stimulants Problematic Use
|
N/A | |
Not yet recruiting |
NCT05134675 -
Does Homebrewing Beer Affect Urinary Tract Symptoms and Bladder Cancer
|
||
Completed |
NCT06114316 -
Recovery of Individuals With Alcohol Use Disorders Based on Roy Adaptation Model
|
N/A | |
Terminated |
NCT04881500 -
Impact of a Brief Motivational Intervention Including Counter-marketing Arguments With a Population of Patients With Moderate to Severe Alcohol Use Disorders Who Are Followed up on an Outpatient Basis (Primary Care or Addictology) (DEPREV_Phase 3)
|
N/A | |
Recruiting |
NCT05490589 -
Evaluation of the Implementation of a Parenting Program in Parents With Children Aged 4 to 12 Years and One Parent With an Alcohol Use Disorders
|
N/A | |
Recruiting |
NCT06105853 -
Neurobehavioral Profiles of Adaptive Stress Responses in Individuals With Alcohol Use Disorder
|
N/A | |
Completed |
NCT03232112 -
Does Treatment With GLP-1 Reduce Alcohol Intake in Patients With Alcohol Dependence?
|
Phase 2 | |
Active, not recruiting |
NCT04927455 -
Pilot Study to Evaluate "Intégrer et Accompagner Les Consommations d'Alcool!" (IACA!)'s Impact and Transferability
|