Study of Familiarity in Alcohol Dependence

Terminated

• Conditions: Alcohol Dependence

• Registration Number: NCT02881424
• Lead Sponsor: University Hospital, Lille

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)

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2016-08-17
• Study First Submitted QC: 2016-08-23
• Study First Posted: 2016-08-29
• Primary Completion: 2018-04
• Study Completion: 2018-04
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-12
• Last Update Posted: 2018-10-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 42

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Familiarity threshold	3 years	calculated from the psychometric function of each participant

Secondary Outcome Measures

Name	Time	Method
BREF score	3 years	neuropsychological score
concomitant treatment	3 years	concomitant treatment posology
MocA score	3 years	Score at the Montreal Cognitive Assessment
RL/RI score	3 years	neuropsychological score
non-consumption of alcohol duration	3 years	non-consumption of alcohol duration
social cognition test	3 years	social cognition test score
Alcohol consumption	3 years	alcohol consumption evaluation

Trial Locations

Locations (2)

University Hospital, Lille - CSAPA; 🇫🇷 Lille, France

University Hospital, Lille - Fontan 2; 🇫🇷 Lille, France