New Relapse Model in Psychiatry

Alcohol Use Disorder Clinical Trial

— NRMP  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06244641
• Other study ID #: 2023/09MAI/22
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 2024
• Est. completion date: February 2028

Study information

• Verified date: January 2024
• Source: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Contact: Claire Emmanuèle Marie Ledouble
• Phone: +32474731113
• Email: claireledouble[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 350
• Est. completion date: February 2028
• Est. primary completion date: April 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• To suffer from AUD

• To be hospitalized

• To speak French fluently

• To be able to give their consent (medically and legally).

Exclusion Criteria:

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

• To suffer from severe cognitive impairment

Related Conditions & MeSH terms

• Alcohol Use Disorder
• Alcoholism
• Recurrence

Intervention

Other:
• Auto-questionnaires, hetero-questionnaires and Evoked-potentials
Evaluations of risk factors of relapse by questionnaires, evaluation of evoked-potentials

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain	Fonds National de la Recherche Scientifique

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Satisfaction of the feedback-measurment-system for clinicians and patients	Simple questions with Likert-scale to evaluate the feedback-measurment-system	Throughout the entire study, approximately during 48 months