NCT02842528

Brief Summary

The purpose of this study is to specify the cognitive and genetic pattern associated with alcohol dependence. Results will help identifying more precisely vulnerability factors associated with this disorder.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
261

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2007

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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

September 1, 2007

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
7 years until next milestone

First Submitted

Initial submission to the registry

June 27, 2016

Completed
28 days until next milestone

First Posted

Study publicly available on registry

July 25, 2016

Completed
Last Updated

July 25, 2016

Status Verified

July 1, 2016

Enrollment Period

1.5 years

First QC Date

June 27, 2016

Last Update Submit

July 20, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • questionnaire

    comparison of questionnaires score for the 3 groups

    Day 0

Secondary Outcomes (1)

  • genetic polymorphism

    Day 0

Study Arms (3)

Alcohol-dependent patients

EXPERIMENTAL
Behavioral: Diagnostic Interview for Genetic StudiesBehavioral: Family Informant Schedule and CriteriaBehavioral: Temperament and Character InventoryBehavioral: Barratt Impulsiveness ScaleBehavioral: Wisconsin Card Sorting TestGenetic: blood sample withdrawn

First-degree relatives of alcohol-dependent probands

ACTIVE COMPARATOR
Behavioral: Diagnostic Interview for Genetic StudiesBehavioral: Family Informant Schedule and CriteriaBehavioral: Temperament and Character InventoryBehavioral: Barratt Impulsiveness ScaleBehavioral: Wisconsin Card Sorting TestGenetic: blood sample withdrawn

Healthy Controls

ACTIVE COMPARATOR
Behavioral: Diagnostic Interview for Genetic StudiesBehavioral: Family Informant Schedule and CriteriaBehavioral: Temperament and Character InventoryBehavioral: Barratt Impulsiveness ScaleBehavioral: Wisconsin Card Sorting TestGenetic: blood sample withdrawn

Interventions

Alcohol-dependent patientsFirst-degree relatives of alcohol-dependent probandsHealthy Controls
Alcohol-dependent patientsFirst-degree relatives of alcohol-dependent probandsHealthy Controls
Alcohol-dependent patientsFirst-degree relatives of alcohol-dependent probandsHealthy Controls
Alcohol-dependent patientsFirst-degree relatives of alcohol-dependent probandsHealthy Controls
Alcohol-dependent patientsFirst-degree relatives of alcohol-dependent probandsHealthy Controls
Alcohol-dependent patientsFirst-degree relatives of alcohol-dependent probandsHealthy Controls

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Alcohol-dependent patients :
  • Males or females, aged 18-65 years, with a diagnosis of alcohol dependence, according to the DSM-IV criteria
  • Patients withdrawn from alcohol at least 2 weeks
  • Native French speaker, able to read French and complete study evaluations
  • Caucasian
  • Able to provide informed written and verbal consent
  • First-degree relatives of alcohol-dependent probands :
  • Males or females, aged 18-65 years
  • Caucasian
  • Native French speaker, able to read French and complete study evaluations
  • Able to provide informed written and verbal consent
  • Healthy Controls :
  • Males or females, aged 18-65 years
  • Caucasian
  • Native French speaker, able to read French and complete study evaluations
  • +1 more criteria

You may not qualify if:

  • Alcohol-dependent patients
  • DSM-IV substance use disorder other than alcohol
  • Severe chronic psychiatric disorders including Bipolar disorder and schizophrenia
  • Mood episode diagnostic according to the DSM-IV criteria in the last six months
  • A significant general medical illness, including neurological disorders
  • A sensorial impairment uncorrected (visual and/or hearing)
  • Individuals who are not covered by national health insurance
  • First-degree relatives of alcohol-dependent probands :
  • Past or recent alcohol and/or drug abuse or dependence
  • Severe chronic psychiatric disorders including Bipolar disorder and schizophrenia
  • Mood episode diagnostic according to the DSM-IV criteria in the last six months
  • A significant general medical illness, including neurological disorders
  • Handling of psychotropics substances
  • A sensorial impairment uncorrected (visual and/or hearing)
  • Individuals who are not covered by national health insurance
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu de Reims

Reims, France, 51092, France

Location

Related Publications (4)

  • Gierski F, Hubsch B, Stefaniak N, Benzerouk F, Cuervo-Lombard C, Bera-Potelle C, Cohen R, Kahn JP, Limosin F. Executive functions in adult offspring of alcohol-dependent probands: toward a cognitive endophenotype? Alcohol Clin Exp Res. 2013 Jan;37 Suppl 1:E356-63. doi: 10.1111/j.1530-0277.2012.01903.x. Epub 2012 Dec 14.

    PMID: 23240659BACKGROUND
  • Benzerouk F, Gierski F, Gorwood P, Ramoz N, Stefaniak N, Hubsch B, Kaladjian A, Limosin F. Brain-derived neurotrophic factor (BDNF) Val66Met polymorphism and its implication in executive functions in adult offspring of alcohol-dependent probands. Alcohol. 2013 Jun;47(4):271-4. doi: 10.1016/j.alcohol.2013.03.001. Epub 2013 Apr 10.

    PMID: 23582695BACKGROUND
  • Raucher-Chene D, Gierski F, Hubsch B, Cuervo-Lombard CV, Bera-Potelle C, Cohen R, Kahn JP, Kaladjian A, Limosin F. Depression, anxiety and personality dimensions in female first-degree relatives of alcohol-dependent probands. Arch Womens Ment Health. 2012 Jun;15(3):229-32. doi: 10.1007/s00737-012-0271-5. Epub 2012 Mar 13.

    PMID: 22411191BACKGROUND
  • Benzerouk F, Gierski F, Raucher-Chene D, Ramoz N, Gorwood P, Kaladjian A, Limosin F. Association study between reward dependence and a functional BDNF polymorphism in adult women offspring of alcohol-dependent probands. Psychiatr Genet. 2015 Oct;25(5):208-11. doi: 10.1097/YPG.0000000000000099.

    PMID: 26204172BACKGROUND

MeSH Terms

Conditions

Alcoholism

Interventions

Wisconsin Card Sorting Test

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Neuropsychological TestsPsychological TestsBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 27, 2016

First Posted

July 25, 2016

Study Start

September 1, 2007

Primary Completion

March 1, 2009

Study Completion

July 1, 2009

Last Updated

July 25, 2016

Record last verified: 2016-07

Locations