NCT02881424

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2015

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

August 17, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 29, 2016

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
Last Updated

October 15, 2018

Status Verified

October 1, 2018

Enrollment Period

3.1 years

First QC Date

August 17, 2016

Last Update Submit

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:
  • 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.

Sponsors & Collaborators

Study Sites (2)

University Hospital, Lille - CSAPA

Lille, 59037, France

Location

University Hospital, Lille - Fontan 2

Lille, 59037, France

Location

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

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 1, 2015

Primary Completion

April 1, 2018

Study Completion

April 1, 2018

Last Updated

October 15, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations

FR(2)