AlcoholismCoVADNCT02842528
Cognitive Vulnerability Factors in Alcohol-dependence
A study testing Diagnostic Interview for Genetic Studies, Family Informant Schedule and Criteria and Temperament and Character Inventory in people with Alcoholism, run by CHU de Reims at 1 site in France.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcoholism
- What is being tested?
- Diagnostic Interview for Genetic Studies, Family Informant Schedule and Criteria and Temperament and Character Inventory
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 261 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2007to Jul 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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- Patients withdrawn from alcohol at least 2 weeks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
Show all 16Show fewer
- 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
Who cannot join
- 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)
Show all 25Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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).
- Conditions
- Alcoholism
- Being tested
- Diagnostic Interview for Genetic Studies, Family Informant Schedule and Criteria, Temperament and Character Inventory, Barratt Impulsiveness Scale, Wisconsin Card Sorting Test
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic Interview for Genetic StudiesBehavioural
Family Informant Schedule and CriteriaBehavioural
Temperament and Character InventoryBehavioural
Barratt Impulsiveness ScaleBehavioural
Wisconsin Card Sorting TestBehavioural
blood sample withdrawnGenetic
| Study group | Role | What they receive |
|---|---|---|
| Alcohol-dependent patients | Experimental | Not described Receives: 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 |
| First-degree relatives of alcohol-dependent probands | Active comparator | Not described Receives: 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 |
| Healthy Controls | Active comparator | Not described Receives: 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 being measured
The primary outcome is the main question the study is designed to answer.
questionnaire
comparison of questionnaires score for the 3 groups
Measured: Day 0
Secondary outcomes (1)
genetic polymorphism
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2016 (estimated)
- Study startSep 2007
- Primary completionMar 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for AlcoholismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 261 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02842528
- Sponsor's protocol ID
- PHRC-IR2006
- Acronym
- CoVAD
- Status last verified
- Jul 2016
- First submitted
- 27 Jun 2016
- Last updated
- 25 Jul 2016
- Results posted
- No
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 23240659Benzerouk 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 23582695Raucher-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 22411191Benzerouk 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
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Mental Flexibility and Inhibition Processes as Cognitive Vulnerability Markers of Alcohol Dependence
- ClinicalTrials.gov ID
- NCT02842528
- Acronym / sponsor ID
- CoVAD / PHRC-IR2006
- Conditions
- Alcoholism
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 261 participants (actual)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- Mar 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 25 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Alcohol-dependent patients | Experimental | 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 |
| First-degree relatives of alcohol-dependent probands | Active comparator | 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 |
| Healthy Controls | Active comparator | 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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
Key exclusion criteria (25 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diagnostic Interview for Genetic Studies | Behavioural | Alcohol-dependent patients, First-degree relatives of alcohol-dependent probands, Healthy Controls |
| Family Informant Schedule and Criteria | Behavioural | Alcohol-dependent patients, First-degree relatives of alcohol-dependent probands, Healthy Controls |
| Temperament and Character Inventory | Behavioural | Alcohol-dependent patients, First-degree relatives of alcohol-dependent probands, Healthy Controls |
| Barratt Impulsiveness Scale | Behavioural | Alcohol-dependent patients, First-degree relatives of alcohol-dependent probands, Healthy Controls |
| Wisconsin Card Sorting Test | Behavioural | Alcohol-dependent patients, First-degree relatives of alcohol-dependent probands, Healthy Controls |
| blood sample withdrawn | Genetic | Alcohol-dependent patients, First-degree relatives of alcohol-dependent probands, Healthy Controls |
Primary outcome
questionnaire
Time frame: Day 0
comparison of questionnaires score for the 3 groups
1 secondary outcome
genetic polymorphism
Time frame: Day 0
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2016.
- Background: PubMed 23240659Gierski 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.
- Background: PubMed 23582695Benzerouk 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.
- Background: PubMed 22411191Raucher-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.
- Background: PubMed 26204172Benzerouk 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diagnostic Interview for Genetic Studies, Family Informant Schedule and Criteria and Temperament and Character Inventory in people with Alcoholism, run by CHU de Reims at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
questionnaire (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02842528, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2016.