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Social Cognition in Severe Alcohol Use Disorder

Study acronym: COSMO
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Notable Recruitment opened
    • Primary completion pushed from May 2028 to Nov 11, 2028
    • Start date changed from estimate of May 2026 to May 11, 2026
    • Site details revised
    v3
  2. Minor Re-verified, no change to tracked fieldsv2
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
79 trials monitored
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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.
Trial Details
NCT Number NCT07464613
Lead Sponsor CHU de Reims
Collaborators: Université de Reims Champagne-Ardenne, Public Mental Health Institution of the Marne
Conditions
(from sponsor)
Alcohol Use Disorder
Related terms Alcoholism, Social Adjustment
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov