Study of Familiarity in Alcohol Dependence

Alcohol Dependence Clinical Trial

— FALCO  

Official title:

Study of Familiarity in Alcohol Dependence : an Hyperfamiliarity for Faces

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02881424
• Other study ID #: 2014_51
• Secondary ID: 2014-A01761-46
• Status: Terminated
• Start date: March 2015
• Est. completion date: April 2018

Study information

• Verified date: October 2018
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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)

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 42
• Est. completion date: April 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Alcohol Dependence
• Alcoholism

Locations

Country	Name	City	State
France	University Hospital, Lille - CSAPA	Lille
France	University Hospital, Lille - Fontan 2	Lille

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Familiarity threshold	calculated from the psychometric function of each participant	3 years
Secondary	Alcohol consumption	alcohol consumption evaluation	3 years
Secondary	MocA score	Score at the Montreal Cognitive Assessment	3 years
Secondary	BREF score	neuropsychological score	3 years
Secondary	RL/RI score	neuropsychological score	3 years
Secondary	non-consumption of alcohol duration	non-consumption of alcohol duration	3 years
Secondary	social cognition test	social cognition test score	3 years
Secondary	concomitant treatment	concomitant treatment posology	3 years