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Cognitive Vulnerability Factors in Alcohol-dependence (CoVAD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02842528
Recruitment Status : Terminated
First Posted : July 25, 2016
Last Update Posted : July 25, 2016
Sponsor:
Information provided by (Responsible Party):
CHU de Reims

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.

Condition or disease Intervention/treatment Phase
Alcoholism 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Inventory Behavioral: Barratt Impulsiveness Scale Behavioral: Wisconsin Card Sorting Test Genetic: blood sample withdrawn Not Applicable

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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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 261 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Study of Mental Flexibility and Inhibition Processes as Cognitive Vulnerability Markers of Alcohol Dependence
Study Start Date : September 2007
Actual Primary Completion Date : March 2009
Actual Study Completion Date : July 2009

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. questionnaire [ Time Frame: Day 0 ]
    comparison of questionnaires score for the 3 groups


Secondary Outcome Measures :
  1. genetic polymorphism [ Time Frame: Day 0 ]


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
Criteria

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:

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

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): NCT02842528


Locations
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France
Chu de Reims
Reims, France, 51092
Sponsors and Collaborators
CHU de Reims
Publications:
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Responsible Party: CHU de Reims
ClinicalTrials.gov Identifier: NCT02842528    
Other Study ID Numbers: PHRC-IR2006
First Posted: July 25, 2016    Key Record Dates
Last Update Posted: July 25, 2016
Last Verified: July 2016
Additional relevant MeSH terms:
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Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders