Clinical trial NCT04647422: Social Cognition and Executive Functions in Alcohol Use Disorders - Transverse Study
Official title: Investigation of Social Cognition and Executive Functions as Cognitive Vulnerability Markers for the Development and Maintenance of Alcohol Use Disorders - a Transverse Study Design
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Use Disorder
Keywords: Alcohol use disorder
high-risk individuals
executive functions
social cognition
endophenotypes
neuropsychology
Lead sponsor: CHU de Reims
Sponsor class: OTHER
First posted: 2020-11-30
Enrollment: 216
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Over the past few years, researchers and clinicians have stressed the major role of executive and social cognition impairments in the development and the maintenance of Alcohol Use Disorders (AUD).

Executive functions are defined as functions for behavioral control that help us to adjust the investigator's behavior in a flexible way in non-familiar, non-routine situations. Executive functions encompass different cognitive processes, such as inhibition, mental flexibility, updating, planification, abstraction, rule deduction or organization. Studies comparing AUD patients to healthy controls have shown that AUD usually is associated with a large range of deficits. More recently studies have also emphasized a weakness of executive functioning among healthy participants with a positive family history of AUD.

Social cognition refers to all cognitive processes that enable us to communicate and to interact with social environment in an appropriate manner. Among the most common social cognition sub-components are theory of mind (defined as the capacity to understand other people's mental states as for instance beliefs and desires), empathy, and emotion recognition. Emotional and interpersonal difficulties have a high prevalence in AUD and chronic alcohol consumption is often linked to social conflicts, misunderstandings, a lack of social support and isolation. Indeed, AUD patients have difficulties in understanding their own mental states and emotions as well as those of their social environment.

Few studies have investigated the interdependency between these cognitive impairments in AUD while a better understanding of the link between executive functions and social cognition seems crucial in order to better characterize the nature of AUD patients' deficits and thus their caring.

Detailed description: The aim of the study is to describe cognitive processes (theory of mind, empathy, and emotion recognition) and executive functions (inhibition, mental flexibility) in patients with AUD and first degree relatives of patients with an AUD.

Eligibility criteria: 1. AUD patients

   Inclusion criteria:
   * Patients between 18 and 60 years old, men or women, following AUD treatment
   * Having a diagnosis of alcohol use disorder according to DSM-5 criteria
   * Patients withdrawn of alcohol for at least 15 days
   * Patients being a native French speaker
   * Patients enrolled in the national healthcare insurance program
   * Patients consenting to participate to 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 substance use disorder during the six months preceding the study, except for tobacco dependence.
   * The presence of any intellectual disability, of pervasive developmental disorders or learning difficulties (especially of dysphasia and dyspraxia)
   * The presence of any neurological disorder or any other disorder affecting the central nervous system including Korsakoff syndrome or Wernicke's encephalopathy
   * Having any uncorrected auditory or visual deficits
2. First-degree relatives of AUD patients

   Inclusion criteria:
   * Participants between 18 and 60 years old, men or women
   * Current and past absence of any alcohol use disorder or any other substance use disorder as defined by DSM-5 diagnostic criteria
   * Participants having at least one first-degree relative presenting an alcohol use disorder (father or sibling)
   * Participants being a native French speaker
   * Participants enrolled in the national healthcare insurance program
   * Participants consenting to participate to the study

   exclusion criteria:
   * The presence of any alcohol use disorder or any other substance use disorder as defined by DSM-5 diagnostic criteria, except for tobacco dependence
   * 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 any alcohol use disorder in the participant's biological mother in order to exclude fetal alcohol spectrum disorders due to prenatal alcohol intoxication
   * The presence of any intellectual disability, of pervasive developmental disorders or learning difficulties (especially of dysphasia and dyspraxia)
   * The presence of any neurological disorder or any other disorder affecting the central nervous system
   * Participants having any uncorrected auditory or visual deficits
3. Healthy control participants (the inclusion and non-inclusion criteria of investigation groups 2 and 4 are identical):

Inclusion criteria:

* Participants between 18 and 60 years old, men or women
* Current and past absence of any alcohol use disorder or any other substance use disorder as defined by DSM-5 diagnostic criteria
* Participants being a native French speaker
* Participants enrolled in the national healthcare insurance program
* Participants consenting to participate to the study

exclusion criteria:

* The presence of any alcohol use disorder or any other substance use disorder as defined by DSM-5 diagnostic criteria, except for tobacco dependence
* 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
* Having any first-degree relative with alcohol use disorder (parents, siblings, children) according to DSM-5 diagnostic criteria
* The presence of any intellectual disability, of pervasive developmental disorders or learning difficulties (especially of dysphasia and dyspraxia)
* The presence of any neurological disorder or any other disorder affecting the central nervous system
* Participants having any uncorrected auditory or visual deficits

Primary outcomes:
measure: Executive functions: mental flexibility performances and processing speed
timeFrame: Day 0
measure: Executive functions: mental flexibility performances
timeFrame: Day 0
measure: Executive functions: prepotent response inhibition
timeFrame: Day 0
measure: Executive functions: inhibition of an ongoing motor response
timeFrame: Day 0
measure: Social cognition: facial emotion recognition
timeFrame: Day 0
measure: Social cognition: cognitive and affective theory of mind
timeFrame: Day 0
Secondary outcomes:
measure: Duration of ocular fixations
timeFrame: Day 0
measure: Number of ocular saccades
timeFrame: Day 0
measure: Localization of the first ocular fixation
timeFrame: Day 0
measure: fMRI behavioral responses during a cognitive and affective theory of mind task
timeFrame: Day 0
measure: fMRI activations during a cognitive and affective theory of mind task
timeFrame: Day 0
Other outcomes:
Locations:
city: Reims
country: France
facility: Damien JOLLY
Study officials:
References: