NCT02881424

Terminated

Study of Familiarity in Alcohol Dependence

University Hospital, Lille Source

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Other study identifiers

Sponsor study identifier

2014_51

Secondary identifiers

2014-A01761-46

OTHER · ID-RCB number, ANSM

Study Type

observational

Actual enrollment (reported)

42

Locations

1 country

Sites

2

Timeline

Study Start

March 2015

Actual (reported)

Primary Completion

April 2018

Actual (reported)

Study Completion

April 2018

Actual (reported)

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

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: terminated
Actual enrollment (reported): 42 participants
Study completion date: April 2018
Actual (reported)
Listed locations: 1 countries · 2 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
March 2015
Actual (reported)
First Submitted
August 17, 2016
Actual (reported)
First Posted
August 29, 2016
Actual (reported)
Primary Completion
April 2018
Actual (reported)
Study Completion
April 2018
Actual (reported)

Last Updated: October 15, 2018
Status Verified: October 2018
Last Update Submitted: October 12, 2018

Conditions

Alcohol Dependence

Keywords

FamiliarityRecollectionFace RecognitionAlcohol dependenceSocial cognition

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (7)

Alcohol consumption
3 years
MocA score
3 years
BREF score
3 years
RL/RI score
3 years
non-consumption of alcohol duration
3 years
+2 more secondary outcomes

Study Arms (2)

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

Eligibility Criteria

Age18 Years - 65 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-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.

You may qualify if:

For all participants:

Sponsors & Collaborators

University Hospital, Lille
Otherlead

Study Sites (2)

University Hospital, Lille - CSAPA

Lille, 59037, France

University Hospital, Lille - Fontan 2

Lille, 59037, France

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

Olivier COTTENCIN, MD, PhD
University Hospital, Lille
PRINCIPAL INVESTIGATOR

Enrollment

42 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: CASE CONTROL
Time Perspective: PROSPECTIVE
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

August 17, 2016

First Posted

August 29, 2016

Study Start

March 2015

Actual (reported)

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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:

Without antecedent or current neurologic disease

Without antecedent or current psychiatric disease

Non-taking psychotropic drugs

You may not qualify if:

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)

Contact the study team to confirm eligibility.

Primary Completion

April 2018

Actual (reported)

Study Completion

April 2018

Actual (reported)

Last Updated

October 15, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing: Will not share

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT02881424
Data provider: ClinicalTrials.gov
Source updated: 2018-10-15
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:26:19 UTC

Locations

FR(2)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (7)

Study Arms (2)

alcohol-dependent patients

healthy controls

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations