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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
261

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
questionnaire
Time Frame: Day 0
comparison of questionnaires score for the 3 groups
Day 0

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2007

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2009

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2009

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 27, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 20, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 25, 2016

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 25, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 20, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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