Alcohol Use DisorderNRMPNCT06244641
New Relapse Model in Psychiatry
A study testing Auto-questionnaires, hetero-questionnaires and Evoked-potentials in people with Alcohol Use Disorder, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
Trial summary
The goal of this clinical trial is to learn about risk factors of relapse in patients with alcohol use disorder. The main questions it aims to answer are : Among patients with Alcohol Use Disorder, are there clusters of patients with the same characteristics and the same outcome ? Which are the risk factors of relapse… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol Use Disorder
- What is being tested?
- Auto-questionnaires, hetero-questionnaires and Evoked-potentials
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 1 siteBelgium
- Study dates
- 12 Nov 2024to Feb 2028
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To suffer from AUD
- To be hospitalized
- To speak French fluently
- To be able to give their consent (medically and legally).
Who cannot join
- To suffer from severe perceptive disabilities (auditory, visual)
- To suffer from severe cognitive impairment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
Cliniques Universitaires Saint-Luc
Brussels, Brussels Capital, 1200
Claire Ledouble, claire.ledouble@uclouvain.be
About this study
Official title: Creation of a Visualization Tool With Integrated Clinical Data to Support Clinical Intervention and Empowerment of Inpatients in Psychiatry : Basis for the Development of a Predictive Model of Relapse
The goal of this clinical trial is to learn about risk factors of relapse in patients with alcohol use disorder. The main questions it aims to answer are :
- Among patients with Alcohol Use Disorder, are there clusters of patients with the same characteristics and the same outcome ?
- Which are the risk factors of relapse that are the most predictive ? Do they vary according to cluster?
- Can a feedback-measurment-system (eg : a feedback of the tests' results) be usefull in a detoxification unit ?
Participants will :
- Complete auto-questionnaires
- Pass hetero-evaluations
- Undergo an electrophysiological battery
- Conditions
- Alcohol Use Disorder
- Being tested
- Auto-questionnaires, hetero-questionnaires and Evoked-potentials
- Keywords
- clustering, relapse, feedback-measurment-system
- Medical subject headings
- Alcoholism, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auto-questionnaires, hetero-questionnaires and Evoked-potentialsOther
Evaluations of risk factors of relapse by questionnaires, evaluation of evoked-potentials
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Not described Receives: Other: Auto-questionnaires, hetero-questionnaires and Evoked-potentials |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relapse or abstinence after detoxification
number of alcohol units and time to relapse or abstinence after detoxification
Measured: Throughout the entire study, approximately during 48 months
Secondary outcomes (1)
Satisfaction of the feedback-measurment-system for clinicians and patients
Simple questions with Likert-scale to evaluate the feedback-measurment-system
Measured: Throughout the entire study, approximately during 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2024
- Study start12 Nov 2024
- Primary completionApr 2027 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- 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
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de Louvain
- Sponsor type
- University, hospital or other
- Collaborators
- Fonds National de la Recherche Scientifique
- Responsible party
- Sponsor
- Investigators
- Philippe de Timary, PhD, Principal investigator, Université catholique de Louvain (Wallonia)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06244641
- Sponsor's protocol ID
- 2023/09MAI/22
- Acronym
- NRMP
- Status last verified
- Apr 2026
- First submitted
- 29 Jan 2024
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Creation of a Visualization Tool With Integrated Clinical Data to Support Clinical Intervention and Empowerment of Inpatients in Psychiatry : Basis for the Development of a Predictive Model of Relapse
- ClinicalTrials.gov ID
- NCT06244641
- Acronym / sponsor ID
- NRMP / 2023/09MAI/22
- Conditions
- Alcohol Use Disorder
- Keywords
- clustering, relapse, feedback-measurment-system
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Collaborators
- Fonds National de la Recherche Scientifique
- Study start
- 12 Nov 2024 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 6 Feb 2024 (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.
The goal of this clinical trial is to learn about risk factors of relapse in patients with alcohol use disorder. The main questions it aims to answer are :
- Among patients with Alcohol Use Disorder, are there clusters of patients with the same characteristics and the same outcome ?
- Which are the risk factors of relapse that are the most predictive ? Do they vary according to cluster?
- Can a feedback-measurment-system (eg : a feedback of the tests' results) be usefull in a detoxification unit ?
Participants will :
- Complete auto-questionnaires
- Pass hetero-evaluations
- Undergo an electrophysiological battery
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Auto-questionnaires, hetero-questionnaires and Evoked-potentials |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- To suffer from AUD
- To be hospitalized
- To speak French fluently
- To be able to give their consent (medically and legally).
Key exclusion criteria (2 listed)
- To suffer from severe perceptive disabilities (auditory, visual)
- To suffer from severe cognitive impairment
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 |
|---|---|---|
| Auto-questionnaires, hetero-questionnaires and Evoked-potentialsEvaluations of risk factors of relapse by questionnaires, evaluation of evoked-potentials | Other | Intervention |
Primary outcome
Relapse or abstinence after detoxification
Time frame: Throughout the entire study, approximately during 48 months
number of alcohol units and time to relapse or abstinence after detoxification
1 secondary outcome
Satisfaction of the feedback-measurment-system for clinicians and patients
Time frame: Throughout the entire study, approximately during 48 months
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 27 Apr 2026.
- Individual participant dataSharing planned: Undecided
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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.
Philippe de Timary, PhD principal investigator
Université catholique de Louvain (Wallonia)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Auto-questionnaires, hetero-questionnaires and Evoked-potentials in people with Alcohol Use Disorder, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
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 4 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 27 Apr 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 Belgium. 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?
Contact Claire Emmanuèle Marie Ledouble (+32474731113, claireledouble@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relapse or abstinence after detoxification (time frame: Throughout the entire study, approximately during 48 months). 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 27 Apr 2026.