NCT07464613 Social Cognition in Severe Alcohol Use Disorder

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This trial targets 60 participants in total. It began in 2026-05-11 with a primary completion date of 2028-11-11.

Brief Summary

With 41,000 deaths per year, alcohol consumption is the second leading cause of preventable mortality in France. Nearly 3.4% of adults engage in excessive and chronic alcohol use, meeting criteria for Severe Alcohol Use Disorder (SAUD). SAUD is associated with cerebral and cognitive alterations, including deficits in social cognition. These deficits manifest as difficulties in perceiving and interpreting social cues during interactions and encompass, in particular, the recognition of emotional facial expressions and the accurate attribution of others' beliefs, emotions, and intentions (i.e., theory of mind). Such alterations contribute to interpersonal difficulties and psychological distress and are recognized as risk factors for the development and maintenance of SAUD. To date, social cognition has primarily been explored through behavioral tests, providing a description of deficits without examining their neuro-structural correlates. Moreover, no neuroscientific study has investigated the impact of sex and concomitant tobacco use on social cognition and associated brain structures in SAUD, although these factors are known to influence both social cognitive abilities and cerebral organization in this disorder. Finally, the everyday consequences of these alterations on social functioning and the trajectory of alcohol consumption remain poorly explored. In this context, the present project aims, first, to explore the neuro-structural correlates of social cognition deficits in SAUD using psychometric assessments (i.e., emotion recognition, theory of mind) combined with magnetic resonance imaging (MRI). The impact of sex and tobacco use will be accounted for by including these variables as covariates in statistical analyses. Second, the project seeks to assess the daily-life impact of social cognition deficits on the social functioning of individuals with SAUD (i.e., quantity and quality of social interactions) and on the evolution of alcohol use behaviors six months after hospitalization (i.e., risk of relapse). The study will include two participant groups: individuals with SAUD and age-, sex-, and education-matched control participants. The expected results will refine our understanding of social cognition alterations in SAUD, thereby contributing to the improvement of current neuroscientific models. These advances will pave the way for the identification of potential targets for prevention programs and therapeutic interventions.

Eligibility Criteria

1. AUD patients Inclusion criteria: * Patients between 18 and 65 years old, men or women, right-handed, following AUD treatment as inpatients or outpatients and currently abstinent * Having a diagnosis of severe alcohol use disorder according to DSM-5 criteria * Native French speakers * Patients enrolled in the national healthcare insurance program * Patients consenting to participate in the study Exclusion criteria: * A diagnosis of schizophrenia, of any other chronic psychotic state, or of bipolar disorder according to DSM-5 criteria * The presence of a current depressive episode as defined by DSM-5 criteria * The presence of another moderate or severe substance use disorder according to DSM-5 criteria, except for tobacco and cannabis if alcohol is the primary substance consumed and the criteria for cannabis dependence are not met * The presence of a neurodevelopmental disorder * The presence of any clinically significant or unstable pathology: organic pathology affecting the central nervous system or disease likely to interfere with assessments, including the neurological complications of alcoholism * Having any uncorrected auditory or visual deficits * Contraindication to the use of MRI * Individuals particularly protected by the law * No smartphone with Apple or Android operating system 2. Healthy control participants: Inclusion criteria: * Participants between 18 and 65 years old, men or women, right-handed * Native French speakers * Participants enrolled in the national healthcare insurance program * Participants consenting to participate in the study Exclusion criteria: * A diagnosis of schizophrenia, of any other chronic psychotic state, or of bipolar disorder according to DSM-5 criteria * The presence of a current depressive episode as defined by DSM-5 criteria * The presence of substance use disorder as defined by DSM-5 diagnostic criteria, except for tobacco dependence * Having any first-degree relative with alcohol use disorder according to DSM-5 diagnostic criteria * The presence of a neurodevelopmental disorder * The presence of any clinically significant or unstable pathology: organic pathology affecting the central nervous system * Having any uncorrected auditory or visual deficits * Contraindication to the use of MRI * Individuals particularly protected by the law * No smartphone with Apple or Android operating system

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