Cognitive Vulnerability Factors in Alcohol-dependence (CoVAD)

July 20, 2016 updated by: CHU de Reims

Study of Mental Flexibility and Inhibition Processes as Cognitive Vulnerability Markers of Alcohol Dependence

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

261

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Reims, France, 51092
        • CHU de Reims

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
questionnaire
Time Frame: Day 0
comparison of questionnaires score for the 3 groups
Day 0

Secondary Outcome Measures

Outcome Measure
Time Frame
genetic polymorphism
Time Frame: Day 0
Day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CHU de Reims

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (Actual)

March 1, 2009

Study Completion (Actual)

July 1, 2009

Study Registration Dates

First Submitted

June 27, 2016

First Submitted That Met QC Criteria

July 20, 2016

First Posted (Estimate)

July 25, 2016

Study Record Updates

Last Update Posted (Estimate)

July 25, 2016

Last Update Submitted That Met QC Criteria

July 20, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PHRC-IR2006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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