Clinical trial NCT02881424: Study of Familiarity in Alcohol Dependence
Official title: Study of Familiarity in Alcohol Dependence : an Hyperfamiliarity for Faces
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Alcohol Dependence
Keywords: Familiarity
Recollection
Face Recognition
Alcohol dependence
Social cognition
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2016-08-29
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 34 participants will be included in 2 groups: one group of alcohol-dependent patients and another group of control subjects matched for age and sex.

Brief summary: Background:

Alcohol-dependence is a chronic disease with a high risk of relapse. The main therapeutic outcome relies on relapse prevention which seeks to identify high risk situations and individual's response to these situations especially the emotional response to social environment. Alcohol-dependence also induces cognitive impairments leading to social cognition impairments increasing the risk of relapse.

Familiarity is a key process in social interactions: it induces the feeling of prior knowledge of a stimulus without remembering consciously its identity. Followed by a second process based on the contribution of contextual information (recollection) familiarity allows face recognition.

Main aim:

Study of familiarity for faces in alcohol-dependence

Secondary objectives:

Highlighting correlations between familiarity impairments and clinical outcomes

Detailed description: Familiarity will be tested by a specific familiarity task using an original paradigm. This paradigm allows the analysis of familiarity as a quantitative process as well as the analysis of personal familiarity to each subject. Three familiar and three unfamiliar faces are morphed in pairs for each participant. The displayed stimuli for each pair of faces are ten morphs with 5 to 95% of familiar face increasing by 10%. Participants are asked to press a button if the displayed stimulus seems familiar. At the end of the task each participant is asked to name the identity of the familiar faces (true or false recognitions, true or false omissions).

Each participant will undergo 2 visits.

* First visit:

  * Checking the inclusion and non-inclusion criteria
  * Clinical report and alcohol consumption evaluation
  * Standardized psychiatric interview (Mini International Neuropsychiatric Interview - MINI)
  * Neuropsychological tests (Montreal Cognitive Assessment - MoCA, "Batterie Rapide d'Efficience Frontale" - BREF, "Rappel Libre et Rappel Indicé à 16 items" - Grober \& Buschke 's test - RL/RI 16)
* Second visit:

  * Checking the non-consumption of alcohol and other drugs (cannabis, amphetamine, cocaine, methamphetamine, ecstasy, opioid)
  * Task of familiarity with a controlling task
  * Social cognition test (Movie for the Assessment of Social Cognition - MASC)

Eligibility criteria: Inclusion Criteria:

* For all participants:

  * With normal vision with or without glasses
  * Understanding the Note of information and signing the consent form
* For alcohol-dependent patients:

  * Being diagnosed with severe alcohol addiction (according to DSM-5)
  * Currently abstinent
* For control subjects:

  * Exclusion of severe alcohol addiction's diagnosis (according to DSM-5)
  * Without antecedent or current neurologic disease
  * Without antecedent or current psychiatric disease
  * Non-taking psychotropic drugs

Exclusion Criteria:

* For all participants:

  * Pregnant or breast-feeding women
  * Cognitive impairment detected by a MoCA score inferior to \< 26/30
  * Physically or mentally not able to pass the tests of the study
  * Taking an unauthorized drug the month before entering the study (other psychotropic drugs than the ones used for withdrawal or alcohol related complications for patients and any psychotropic drug for control subject)
  * Being diagnosed with a severe addiction other than to caffeine or tobacco (according to DSM-5)
  * Criteria for a plausible fetal alcohol syndrome
* For alcohol-dependent patients:

  * Being diagnosed with schizophrenia or bipolar disorder (according to DSM-5)

Primary outcomes:
measure: Familiarity threshold
timeFrame: 3 years
Secondary outcomes:
measure: Alcohol consumption
timeFrame: 3 years
measure: MocA score
timeFrame: 3 years
measure: BREF score
timeFrame: 3 years
measure: RL/RI score
timeFrame: 3 years
measure: non-consumption of alcohol duration
timeFrame: 3 years
measure: social cognition test
timeFrame: 3 years
measure: concomitant treatment
timeFrame: 3 years
Other outcomes:
Locations:
city: Lille
country: France
facility: University Hospital, Lille - CSAPA
city: Lille
country: France
facility: University Hospital, Lille - Fontan 2
Study officials:
affiliation: University Hospital, Lille
name: Olivier COTTENCIN, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: