Alcohol DependenceFALCONCT02881424
Study of Familiarity in Alcohol Dependence
An observational study of Alcohol Dependence, run by University Hospital, Lille at 2 sites in France.
Trial summary
Background: Alcohol-dependence is a chronic disease with a high risk of relapse. The main therapeutic outcome relies on relapse prevention which seeks to identify high risk situations and individual's response to these situations especially the emotional response to social environment. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Dependence
- How many people
- 42 participants
- Where
- 2 sitesFrance
- Study dates
- Mar 2015to Apr 2018
- Phase
- Observational
- 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
Study population: 34 participants will be included in 2 groups: one group of alcohol-dependent patients and another group of control subjects matched for age and sex.
Who may be able to join
- For all participants:
- With normal vision with or without glasses
- Understanding the Note of information and signing the consent form
- For alcohol-dependent patients:
- Being diagnosed with severe alcohol addiction (according to DSM-5)
- Currently abstinent
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- For control subjects:
- Exclusion of severe alcohol addiction's diagnosis (according to DSM-5)
- Without antecedent or current neurologic disease
- Without antecedent or current psychiatric disease
- Non-taking psychotropic drugs
Who cannot join
- For all participants:
- Pregnant or breast-feeding women
- Cognitive impairment detected by a MoCA score inferior to < 26/30
- Physically or mentally not able to pass the tests of the study
- Taking an unauthorized drug the month before entering the study (other psychotropic drugs than the ones used for withdrawal or alcohol related complications for patients and any psychotropic drug for control subject)
- Being diagnosed with a severe addiction other than to caffeine or tobacco (according to DSM-5)
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- Criteria for a plausible fetal alcohol syndrome
- For alcohol-dependent patients:
- Being diagnosed with schizophrenia or bipolar disorder (according to DSM-5)
Trial locations and contacts
2 sites in 1 country.
France2 sites
University Hospital, Lille - CSAPA
Lille, 59037
University Hospital, Lille - Fontan 2
Lille, 59037
About this study
Official title: Study of Familiarity in Alcohol Dependence : an Hyperfamiliarity for Faces
Background:
Alcohol-dependence is a chronic disease with a high risk of relapse. The main therapeutic outcome relies on relapse prevention which seeks to identify high risk situations and individual's response to these situations especially the emotional response to social environment. Alcohol-dependence also induces cognitive impairments leading to social cognition impairments increasing the risk of relapse.
Read more
Familiarity is a key process in social interactions: it induces the feeling of prior knowledge of a stimulus without remembering consciously its identity. Followed by a second process based on the contribution of contextual information (recollection) familiarity allows face recognition.
Main aim:
Study of familiarity for faces in alcohol-dependence
Secondary objectives:
Highlighting correlations between familiarity impairments and clinical outcomes
Read the detailed description
Familiarity will be tested by a specific familiarity task using an original paradigm. This paradigm allows the analysis of familiarity as a quantitative process as well as the analysis of personal familiarity to each subject. Three familiar and three unfamiliar faces are morphed in pairs for each participant. The displayed stimuli for each pair of faces are ten morphs with 5 to 95% of familiar face increasing by 10%. Participants are asked to press a button if the displayed stimulus seems familiar. At the end of the task each participant is asked to name the identity of the familiar faces (true or false recognitions, true or false omissions).
Each participant will undergo 2 visits.
- First visit:
- Checking the inclusion and non-inclusion criteria
- Clinical report and alcohol consumption evaluation
- Standardized psychiatric interview (Mini International Neuropsychiatric Interview - MINI)
- Neuropsychological tests (Montreal Cognitive Assessment - MoCA, "Batterie Rapide d'Efficience Frontale" - BREF, "Rappel Libre et Rappel Indicé à 16 items" - Grober \& Buschke 's test - RL/RI 16)
- Second visit:
- Checking the non-consumption of alcohol and other drugs (cannabis, amphetamine, cocaine, methamphetamine, ecstasy, opioid)
- Task of familiarity with a controlling task
- Social cognition test (Movie for the Assessment of Social Cognition - MASC)
- Conditions
- Alcohol Dependence
- Keywords
- Familiarity, Recollection, Face Recognition, Alcohol dependence, Social cognition
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| alcohol-dependent patients | a group of 34 alcohol-dependent patients, currently abstinent | |
| healthy controls | a group of control subjects, without neurologic or psychiatric disease, matched for age and sex with the alcohol-dependent participants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Familiarity threshold
calculated from the psychometric function of each participant
Measured: 3 years
Secondary outcomes (7)
Alcohol consumption
alcohol consumption evaluation
Measured: 3 years
MocA score
Score at the Montreal Cognitive Assessment
Measured: 3 years
BREF score
neuropsychological score
Measured: 3 years
RL/RI score
neuropsychological score
Measured: 3 years
non-consumption of alcohol duration
non-consumption of alcohol duration
Measured: 3 years
social cognition test
social cognition test score
Measured: 3 years
concomitant treatment
concomitant treatment posology
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2016 (estimated)
- Study startMar 2015
- Primary completionApr 2018
- Study completionApr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol DependenceStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olivier COTTENCIN, MD, PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02881424
- Sponsor's protocol ID
- 2014_51
- Other IDs
- 2014-A01761-46
- Acronym
- FALCO
- Status last verified
- Oct 2018
- First submitted
- 17 Aug 2016
- Last updated
- 15 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Familiarity in Alcohol Dependence : an Hyperfamiliarity for Faces
- ClinicalTrials.gov ID
- NCT02881424
- Acronym / sponsor ID
- FALCO / 2014_51
- Conditions
- Alcohol Dependence
- Keywords
- Familiarity, Recollection, Face Recognition, Alcohol dependence, Social cognition
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- Mar 2015 (actual)
- Primary completion
- Apr 2018 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 29 Aug 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.
Background:
Alcohol-dependence is a chronic disease with a high risk of relapse. The main therapeutic outcome relies on relapse prevention which seeks to identify high risk situations and individual's response to these situations especially the emotional response to social environment. Alcohol-dependence also induces cognitive impairments leading to social cognition impairments increasing the risk of relapse.
Familiarity is a key process in social interactions: it induces the feeling of prior knowledge of a stimulus without remembering consciously its identity. Followed by a second process based on the contribution of contextual information (recollection) familiarity allows face recognition.
Main aim:
Study of familiarity for faces in alcohol-dependence
Secondary objectives:
Highlighting correlations between familiarity impairments and clinical outcomes
Detailed description
Familiarity will be tested by a specific familiarity task using an original paradigm. This paradigm allows the analysis of familiarity as a quantitative process as well as the analysis of personal familiarity to each subject. Three familiar and three unfamiliar faces are morphed in pairs for each participant. The displayed stimuli for each pair of faces are ten morphs with 5 to 95% of familiar face increasing by 10%. Participants are asked to press a button if the displayed stimulus seems familiar. At the end of the task each participant is asked to name the identity of the familiar faces (true or false recognitions, true or false omissions).
Each participant will undergo 2 visits.
- First visit:
- Checking the inclusion and non-inclusion criteria
- Clinical report and alcohol consumption evaluation
- Standardized psychiatric interview (Mini International Neuropsychiatric Interview - MINI)
- Neuropsychological tests (Montreal Cognitive Assessment - MoCA, "Batterie Rapide d'Efficience Frontale" - BREF, "Rappel Libre et Rappel Indicé à 16 items" - Grober \& Buschke 's test - RL/RI 16)
- Second visit:
- Checking the non-consumption of alcohol and other drugs (cannabis, amphetamine, cocaine, methamphetamine, ecstasy, opioid)
- Task of familiarity with a controlling task
- Social cognition test (Movie for the Assessment of Social Cognition - MASC)
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| alcohol-dependent patients | – | –a group of 34 alcohol-dependent patients, currently abstinent |
| healthy controls | – | –a group of control subjects, without neurologic or psychiatric disease, matched for age and sex with the alcohol-dependent participants |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 34 participants will be included in 2 groups: one group of alcohol-dependent patients and another group of control subjects matched for age and sex.
Key inclusion criteria (11 listed)
- For all participants:
- For alcohol-dependent patients:
- For control subjects:
Key exclusion criteria (9 listed)
- For all participants:
- For alcohol-dependent patients:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Familiarity threshold
Time frame: 3 years
calculated from the psychometric function of each participant
7 secondary outcomes
Alcohol consumption
Time frame: 3 years
MocA score
Time frame: 3 years
BREF score
Time frame: 3 years
RL/RI score
Time frame: 3 years
non-consumption of alcohol duration
Time frame: 3 years
social cognition test
Time frame: 3 years
concomitant treatment
Time frame: 3 years
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 15 Oct 2018.
- Individual participant dataSharing planned: No
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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.
Olivier COTTENCIN, MD, PhD principal investigator
University Hospital, Lille
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alcohol Dependence, run by University Hospital, Lille at 2 sites 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 11 inclusion and 9 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 15 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Familiarity threshold (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Oct 2018.