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Study of Familiarity in Alcohol Dependence (FALCO)

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ClinicalTrials.gov Identifier: NCT02881424
Recruitment Status : Recruiting
First Posted : August 29, 2016
Last Update Posted : April 13, 2018
Sponsor:
Information provided by (Responsible Party):
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


Condition or disease
Alcohol Dependence

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 Type : Observational
Estimated Enrollment : 68 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Study of Familiarity in Alcohol Dependence : an Hyperfamiliarity for Faces
Actual Study Start Date : March 2015
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : April 2018

Resource links provided by the National Library of Medicine


Group/Cohort
alcohol-dependent patients
a group of 34 alcohol-dependent patients, currently abstinent
healthy controls
a group of control subjects, without neurologic or psychiatric disease, matched for age and sex with the alcohol-dependent participants



Primary Outcome Measures :
  1. Familiarity threshold [ Time Frame: 3 years ]
    calculated from the psychometric function of each participant


Secondary Outcome Measures :
  1. Alcohol consumption [ Time Frame: 3 years ]
    alcohol consumption evaluation

  2. MocA score [ Time Frame: 3 years ]
    Score at the Montreal Cognitive Assessment

  3. BREF score [ Time Frame: 3 years ]
    neuropsychological score

  4. RL/RI score [ Time Frame: 3 years ]
    neuropsychological score

  5. non-consumption of alcohol duration [ Time Frame: 3 years ]
    non-consumption of alcohol duration

  6. social cognition test [ Time Frame: 3 years ]
    social cognition test score

  7. concomitant treatment [ Time Frame: 3 years ]
    concomitant treatment posology



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02881424


Contacts
Contact: Olivier COTTENCIN, MD,PhD olivier.cottencin@chru-lille.fr
Contact: Philippe LAPIERRE philippe.lapierre@chru-lille.fr

Locations
France
University Hospital, Lille - CSAPA Recruiting
Lille, France, 59037
Principal Investigator: Thierry DANEL         
University Hospital, Lille - Fontan 2 Recruiting
Lille, France, 59037
Principal Investigator: Olivier COTTENCIN         
Sponsors and Collaborators
University Hospital, Lille
Investigators
Principal Investigator: Olivier COTTENCIN, MD, PhD University Hospital, Lille

Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT02881424     History of Changes
Other Study ID Numbers: 2014_51
2014-A01761-46 ( Other Identifier: ID-RCB number, ANSM )
First Posted: August 29, 2016    Key Record Dates
Last Update Posted: April 13, 2018
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University Hospital, Lille:
Familiarity
Recollection
Face Recognition
Alcohol dependence
Social cognition

Additional relevant MeSH terms:
Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs