NCT06244641

Brief 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 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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
350

participants targeted

Target at P75+ for not_applicable

Timeline
21mo left

Started Nov 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress46%
Nov 2024Feb 2028

First Submitted

Initial submission to the registry

January 29, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 6, 2024

Completed
9 months until next milestone

Study Start

First participant enrolled

November 12, 2024

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2027

Expected
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2028

Last Updated

April 27, 2026

Status Verified

April 1, 2026

Enrollment Period

2.4 years

First QC Date

January 29, 2024

Last Update Submit

April 24, 2026

Conditions

Keywords

clusteringrelapsefeedback-measurment-system

Outcome Measures

Primary Outcomes (1)

  • Relapse or abstinence after detoxification

    number of alcohol units and time to relapse or abstinence after detoxification

    Throughout the entire study, approximately during 48 months

Secondary Outcomes (1)

  • Satisfaction of the feedback-measurment-system for clinicians and patients

    Throughout the entire study, approximately during 48 months

Study Arms (1)

Intervention

EXPERIMENTAL
Other: Auto-questionnaires, hetero-questionnaires and Evoked-potentials

Interventions

Evaluations of risk factors of relapse by questionnaires, evaluation of evoked-potentials

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • To suffer from AUD
  • To be hospitalized
  • To speak French fluently
  • To be able to give their consent (medically and legally).

You may not qualify if:

  • To suffer from severe perceptive disabilities (auditory, visual)
  • To suffer from severe cognitive impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cliniques Universitaires Saint-Luc

Brussels, Brussels Capital, 1200, Belgium

RECRUITING

MeSH Terms

Conditions

AlcoholismRecurrence

Interventions

Evoked Potentials

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental DisordersDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cortical ExcitabilityElectrophysiological PhenomenaPhysiological PhenomenaNervous System Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Philippe de Timary, PhD

    Université catholique de Louvain (Wallonia)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Claire Emmanuèle Marie Ledouble

CONTACT

Philippe de Timary, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2024

First Posted

February 6, 2024

Study Start

November 12, 2024

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

February 1, 2028

Last Updated

April 27, 2026

Record last verified: 2026-04

Locations