Transplant; Failure, LiverAddictoliveNCT05322226
Addiction Intervention in Liver Transplantation Candidates
A study testing Addiction follow-up before and after liver transplantation in people with Transplant; Failure, Liver and Addiction, Alcohol, run by University Hospital, Montpellier at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Transplant; Failure, Liver, Addiction, Alcohol
- What is being tested?
- Addiction follow-up before and after liver transplantation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteFrance
- Study dates
- 27 Jul 2022to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- all adults undergoing pre-transplant assessment in the Liver Transplantation Unit of University Hospital of Montpellier, providing oral informed consent.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Department of hepato-gastroenterology and liver transplantation
Montpellier, Occitanie, 34090
About this study
Official 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.
Read the 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.
- Conditions
- Transplant; Failure, Liver, Addiction, Alcohol
- Being tested
- Addiction follow-up before and after liver transplantation
- Keywords
- Liver transplantation, Alcohol relapse, Biological markers of alcohol consumption, Addiction follow up
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Addiction follow-up before and after liver transplantationBehavioural
Addiction consult and follow-up
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Behavioral: Addiction follow-up before and after liver transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Secondary outcomes (7)
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.
Measured: 1 year
Addiction consult
Rate of patient complying with their appointment
Measured: 1 year
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).
Measured: 1 year
Caracterization of contraindicated patients
Rates and characteristics of patients with temporary and/or permanent addiction contraindication
Measured: 1 year
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.
Measured: Every 3 months during 1 year
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.)
Measured: Every 3 months during 1 year
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.)
Measured: Every 3 months during 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2022
- Study start27 Jul 2022
- Primary completion26 Sep 2024
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transplant; Failure, LiverStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Helene Donnadieu, MH PD, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05322226
- Sponsor's protocol ID
- RECHMPL21_0516
- Acronym
- Addictolive
- Status last verified
- Jun 2026
- First submitted
- 30 Mar 2022
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an Addiction Intervention in Candidates for Liver Transplantation
- ClinicalTrials.gov ID
- NCT05322226
- Acronym / sponsor ID
- Addictolive / RECHMPL21_0516
- Conditions
- Transplant; Failure, Liver, Addiction, Alcohol
- Keywords
- Liver transplantation, Alcohol relapse, Biological markers of alcohol consumption, Addiction follow up
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 64 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 27 Jul 2022 (actual)
- Primary completion
- 26 Sep 2024 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 11 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults undergoing pre- liver transplant assessment | Other | Behavioral: Addiction follow-up before and after liver transplantationAll 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). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- all adults undergoing pre-transplant assessment in the Liver Transplantation Unit of University Hospital of Montpellier, providing oral informed consent.
Key exclusion criteria (7 listed)
- 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
- not registered on the liver transplant waiting-list or not transplanted during the study period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Addiction follow-up before and after liver transplantationAddiction consult and follow-up | Behavioural | Adults undergoing pre- liver transplant assessment |
Primary outcome
Rate of liver transplant patients with sustained alcohol relapse one year after liver transplant
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
7 secondary outcomes
Description of addictological means implemented during follow-up.
Time frame: 1 year
Addiction consult
Time frame: 1 year
Addiction consult following biology results
Time frame: 1 year
Caracterization of contraindicated patients
Time frame: 1 year
Rate of transplanted patients with tobacco and other psycoactive substance consumption during the first year after liver transplant
Time frame: Every 3 months during 1 year
Description of urinary marker of alcohol consumption.
Time frame: Every 3 months during 1 year
Description of blood marker of alcohol consumption.
Time frame: Every 3 months during 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Helene Donnadieu, MH PD principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Addiction follow-up before and after liver transplantation in people with Transplant; Failure, Liver and Addiction, Alcohol, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of liver transplant patients with sustained alcohol relapse one year after liver transplant (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.