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TerminatedNCT02842528CoVADUpdated Jul 25, 2016

Cognitive Vulnerability Factors in Alcohol-dependence

An interventional study of Diagnostic Interview for Genetic Studies and Family Informant Schedule and Criteria in Alcoholism, sponsored by CHU de Reims. Terminated at 1 site in France. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-07-25.

Sponsored by CHU de Reims · Not applicable and Interventional

Phase
Not applicable
Study type
Interventional
Enrollment
261
Allocation
Non-randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the detailed description

Alcohol dependence involves both environmental and genetic vulnerability factors. Although it has a rather high degree of heritability (estimates range between 40% and 60%), vulnerability to alcohol dependence is broadly recognised as a complex polygenic phenotype. To clarify the risk factors involved in alcohol dependence, attempts have been made to identify endophenotypes in alcohol dependent patients and their relatives. Endophenotypes are defined as heritable traits associated with an increased risk for developing a disorder; they must be found in probands and their unaffected relatives at a higher rate than in the general population and must be associated with a specific genetic pattern. In the present study the investigators investigate the cognitive performance of alcohol dependent patients in comparison with a group of adult non-alcoholic offspring of alcohol-dependent patients and a group of participants without family history of alcohol dependence. The investigators also explore the relation between familial density of alcoholism and cognitive performance, particularly mental flexibility and inhibition. Genetic analysis will also be conducted to investigate the relationship between cognitive performance and genetic patterns (single nucleotide polymorphisms).

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Conditions studied

  • Alcoholism

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03

In context

Alcoholism

1,634 studies on the registry are indexed under Alcoholism; 329 are open to participants now.

This study's enrollment of 261 is above the median of 88 across 1,395 interventional studies indexed under Alcoholism.

Browse Alcoholism studies →

Lead sponsor

CHU de Reims is the lead sponsor of 275 studies on the registry; 49 are open to participants now.

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Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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
  • Able to provide informed written and verbal consent

Exclusion criteria

Exclusion Criteria:

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

Healthy Controls :

  • A personal or first-degree-relative history of alcohol dependence
  • Past or recent alcohol and/or drug abuse or dependence
  • Total abstinence from 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
  • Handling of psychotropics substances
  • A sensorial impairment uncorrected (visual and/or hearing)
  • Individuals who are not covered by national health insurance
05

Study design

Phase
Not applicable
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
261 participants (actual)

Study arms

  • Experimental
    Alcohol-dependent patients

    Behavioral: Diagnostic Interview for Genetic Studies · Behavioral: Family Informant Schedule and Criteria · Behavioral: Temperament and Character Inventory · Behavioral: Barratt Impulsiveness Scale · Behavioral: Wisconsin Card Sorting Test · Genetic: blood sample withdrawn

  • Active comparator
    First-degree relatives of alcohol-dependent probands

    Behavioral: Diagnostic Interview for Genetic Studies · Behavioral: Family Informant Schedule and Criteria · Behavioral: Temperament and Character Inventory · Behavioral: Barratt Impulsiveness Scale · Behavioral: Wisconsin Card Sorting Test · Genetic: blood sample withdrawn

  • Active comparator
    Healthy Controls

    Behavioral: Diagnostic Interview for Genetic Studies · Behavioral: Family Informant Schedule and Criteria · Behavioral: Temperament and Character Inventory · Behavioral: Barratt Impulsiveness Scale · Behavioral: Wisconsin Card Sorting Test · Genetic: blood sample withdrawn

Interventions

  • BehavioralDiagnostic Interview for Genetic Studies
  • BehavioralFamily Informant Schedule and Criteria
  • BehavioralTemperament and Character Inventory
  • BehavioralBarratt Impulsiveness Scale
  • BehavioralWisconsin Card Sorting Test
  • Geneticblood sample withdrawn
06

What researchers measure

Primary outcomes

  1. questionnaire

    comparison of questionnaires score for the 3 groups

    Time frame: Day 0

Secondary outcomes

  1. genetic polymorphism

    Time frame: Day 0

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Study locations

1 site
  • Chu de Reims
    Reims, France 51092, France
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References and documents

Publications

  • 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. PubMed 23240659 ↗
  • 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. PubMed 23582695 ↗
  • 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. PubMed 22411191 ↗
  • 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. PubMed 26204172 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 25, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02842528
Lead sponsor
CHU de Reims
Responsible party
Sponsor
First posted
Jul 25, 2016
Start date
Sep 2007
Primary completion
Mar 2009
Completion
Jul 2009
Last update
Jul 25, 2016
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.

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