- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05636033
Semantic Networks in Alcohol Use Disorder Patients: Exploratory Study (ALCOOLNET)
Alcohol Use Disorder (AUD) is a major public health problem, characterized by a high rate of relapse. Chronic and excessive alcohol consumption notably induces frontal brain alterations and cognitive impairments such as executive dysfunction and an attentional bias for alcohol, participating to the risk of relapse. In effect, AUD patients preferentially process alcohol-related cues, which could reflect a reorganization of the patients' semantic network. The investigators hypothesize that in AUD patients, semantic associations in memory are reorganized with a higher centrality of alcohol-related elements. To the investigators knowledge, no studies have explored semantic associations and/or semantic networks in AUD.
A study, conducted in patients with neurological damage, showed that frontal lesions are associated with excessive strength in semantic associations, and difficulties to generate remote associations. This excessive strength in semantic associations could reduce the ability to inhibit automatisms and to adapt to new context.
Objective: The objective of this study is to explore whether and how AUD patients have a different organization of semantic associations than healthy controls, and whether this reorganization influences the alcohol consumption over the months following the withdrawal. The investigators will also explore how it relates to neuropsychological assessment of flexibility, executive functions, and impulsivity. To these purposes, the investigators will use two original verbal tasks (Free Generation of Associates Task, FGAT and Associative Judgment Task, AJT) assessing word associations and allowing the estimation of semantic networks using graph theory, in combination with neuropsychological testing, in AUD patients and in healthy controls.
Methods: This study will include a group of 30 AUD patients and a group of 30 healthy controls. Both groups will be assessed twice, at baseline (T1; early in abstinence for AUD patients) and after a three-month period (T3). For the two groups, T1 and T3 assessments will include the two semantic association tasks (FGAT and AJT). For AUD patients, assessments will also involve neuropsychological testing of impulsivity, flexibility, and attentional bias. Besides, in AUD patients, data about alcohol consumptions will be collected six weeks (T2) and three months (T3) following the baseline assessment to classify patients as relapsers or abstainers.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Île-de-France Region
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Paris, Île-de-France Region, France, 75010
- Fernand Widal Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
For alcohol use disorder patients
- Severe alcohol use disorder
- French as mother tongue
- Right-hander
- Patient abstinent from alcohol since 15 to 30 days at the inclusion
- Patient free from benzodiazepine since at least 48hours at the inclusion
- Patient who gave his informed written consent
- Currently in outpatient or inpatient care
For healthy controls
- French as mother tongue
- Right-hander
- Participant who gave his informed written consent
Exclusion Criteria:
For alcohol use disorder patients
- Patient under guardianship or under justice safeguard measures
- Patient under measure of therapeutic injunction
- Pregnancy or breastfeeding declared
- Meeting Diagnostic and Statistical Manual 5 (DSM) criteria for substance use disorder other than Tobacco
- Meeting DSM-5 criteria for non substance use disorder
- Patient presenting severe or progressive disease that interfere with experimental tasks, such as neurological diseases (TBI, epilepsy, stoke) , hepatic diseases, cancer, HIV, Hepatitis C Virus (HCV), and unstable psychiatric comorbidities.
For healthy controls
- Participant under guardianship or under justice safeguard measures
- Participant under measure of therapeutic injunction
- Pregnancy or breastfeeding declared
- Meeting DSM-5 criteria for alcohol use disorder
- Meeting DSM-5 criteria for substance use disorder other than Tobacco
- Meeting DSM-5 criteria for non substance use disorder
- Currently under benzodiazepine
- Participant presenting severe or progressive disease that interfere with experimental tasks, such as neurological diseases (TBI, epilepsy, stoke) , hepatic diseases, cancer, HIV, HCV, and unstable psychiatric comorbidities.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
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Healthy controls
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Alcohol use disorder patients
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Description of the semantic associations using FGAT
Time Frame: At baseline (T1)
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The Free Generation Associated Tasks will be used in Alcohol use disorder patients and Healthy controls
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At baseline (T1)
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Description of the semantic associations using AJT
Time Frame: At baseline (T1)
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The Associative Judgment Task will be used in Alcohol use disorder patients and Healthy controls
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At baseline (T1)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Impact of medications on the semantic association performance
Time Frame: At baseline (T1)
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At baseline (T1)
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Impact of age on the semantic association performance
Time Frame: At baseline (T1)
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At baseline (T1)
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Impact of the study level on the semantic association performance
Time Frame: At baseline (T1)
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At baseline (T1)
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Impact of gender on the semantic association performance
Time Frame: At baseline (T1)
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At baseline (T1)
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Impact of the duration of dependence on the semantic association performance
Time Frame: At baseline (T1)
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At baseline (T1)
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Impact of cognitive performance on the semantic association performance
Time Frame: At baseline (T1)
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The Go /No Go performance will be collected in Alcohol use disorder patients
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At baseline (T1)
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Test of the predictive value of FGAT performance assessed at T1 on alcohol consumption during the six weeks following the Baseline
Time Frame: Baseline (T1) for FGAT ; T2 (6 weeks after T1) for alcohol consumption
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Baseline (T1) for FGAT ; T2 (6 weeks after T1) for alcohol consumption
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Test of the predictive value of AJT performance assessed at T1 on alcohol consumption during the six weeks following the Baseline
Time Frame: Baseline (T1) for AJT ; T2 (6 weeks after T1) for alcohol consumption
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Baseline (T1) for AJT ; T2 (6 weeks after T1) for alcohol consumption
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Test of the predictive value of FGAT performance assessed at T1 on alcohol consumption during the three months following the Baseline
Time Frame: Baseline (T1) for FGAT ; T3 (3 months after T1) for alcohol consumption
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Baseline (T1) for FGAT ; T3 (3 months after T1) for alcohol consumption
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Test of the predictive value of AJT performance assessed at T1 on alcohol consumption during the three months following the Baseline
Time Frame: Baseline (T1) for AJT ; T3 (3 months after T1) for alcohol consumption
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Baseline (T1) for AJT ; T3 (3 months after T1) for alcohol consumption
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Evolution of FGAT performance, comparison between alcohol use disorder patients and healthy controls
Time Frame: T1 (baseline) and T3 (3 months after baseline)
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T1 (baseline) and T3 (3 months after baseline)
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Evolution of AJT performance, comparison between alcohol use disorder patients and healthy controls
Time Frame: T1 (baseline) and T3 (3 months after baseline)
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T1 (baseline) and T3 (3 months after baseline)
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Link between the evolution of FGAT performance and the level of alcohol consumption
Time Frame: Baseline (T1) for FGAT and 3 months after baseline (T3) for FGAT and the level of alcohol consumption)
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The level of alcohol consumption will be assessed using the Timeline Followback method
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Baseline (T1) for FGAT and 3 months after baseline (T3) for FGAT and the level of alcohol consumption)
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Link between the evolution of AJT performance and alcohol consumption
Time Frame: Baseline (T1) for AJT and 3 months after baseline (T3) for AJT and the level of alcohol consumption)
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The level of alcohol consumption will be assessed using the Timeline Followback method
|
Baseline (T1) for AJT and 3 months after baseline (T3) for AJT and the level of alcohol consumption)
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Link between the evolution of FGAT performance and the evolution of cognitive performance
Time Frame: Baseline (T1) and 3 months after baseline (T3)
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The Go /No Go performance will be used in alcohol use disorder patients
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Baseline (T1) and 3 months after baseline (T3)
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Link between the evolution of AJT performance and the evolution of cognitive performance
Time Frame: Baseline (T1) and 3 months after baseline (T3)
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The Go /No Go performance will be used in alcohol use disorder patients
|
Baseline (T1) and 3 months after baseline (T3)
|
Collaborators and Investigators
Investigators
- Principal Investigator: Alexandra Dereux, PH (MD), APHP
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- C22-01
- 2022-A01903-40 (Registry Identifier: ID RCB)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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