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

Completed

Study Type

Observational

Enrollment (Actual)

41

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

    • Île-de-France Region
      • Paris, Île-de-France Region, France, 75010
        • Fernand Widal Hospital

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

30 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Two groups of participants will be included in this study. The first one consists of a pool of alcohol use disorder, the second one consists of a pool of healthy controls ; they will be matched as much as possible on age, gender, and educational level.

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

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

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Healthy controls
Alcohol use disorder patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Description of the semantic associations using FGAT
Time Frame: At baseline (T1)
The Free Generation Associated Tasks will be used in Alcohol use disorder patients and Healthy controls
At baseline (T1)
Description of the semantic associations using AJT
Time Frame: At baseline (T1)
The Associative Judgment Task will be used in Alcohol use disorder patients and Healthy controls
At baseline (T1)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Impact of medications on the semantic association performance
Time Frame: At baseline (T1)
At baseline (T1)
Impact of age on the semantic association performance
Time Frame: At baseline (T1)
At baseline (T1)
Impact of the study level on the semantic association performance
Time Frame: At baseline (T1)
At baseline (T1)
Impact of gender on the semantic association performance
Time Frame: At baseline (T1)
At baseline (T1)
Impact of the duration of dependence on the semantic association performance
Time Frame: At baseline (T1)
At baseline (T1)
Impact of cognitive performance on the semantic association performance
Time Frame: At baseline (T1)
The Go /No Go performance will be collected in Alcohol use disorder patients
At baseline (T1)
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
Baseline (T1) for FGAT ; T2 (6 weeks after T1) for alcohol consumption
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
Baseline (T1) for AJT ; T2 (6 weeks after T1) for alcohol consumption
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
Baseline (T1) for FGAT ; T3 (3 months after T1) for alcohol consumption
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
Baseline (T1) for AJT ; T3 (3 months after T1) for alcohol consumption
Evolution of FGAT performance, comparison between alcohol use disorder patients and healthy controls
Time Frame: T1 (baseline) and T3 (3 months after baseline)
T1 (baseline) and T3 (3 months after baseline)
Evolution of AJT performance, comparison between alcohol use disorder patients and healthy controls
Time Frame: T1 (baseline) and T3 (3 months after baseline)
T1 (baseline) and T3 (3 months after baseline)
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)
The level of alcohol consumption will be assessed using the Timeline Followback method
Baseline (T1) for FGAT and 3 months after baseline (T3) for FGAT and the level of alcohol consumption)
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)
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)
Link between the evolution of FGAT performance and the evolution of cognitive performance
Time Frame: Baseline (T1) and 3 months after baseline (T3)
The Go /No Go performance will be used in alcohol use disorder patients
Baseline (T1) and 3 months after baseline (T3)
Link between the evolution of AJT performance and the evolution of cognitive performance
Time Frame: Baseline (T1) and 3 months after baseline (T3)
The Go /No Go performance will be used in alcohol use disorder patients
Baseline (T1) and 3 months after baseline (T3)

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Alexandra Dereux, PH (MD), APHP

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 (Actual)

April 19, 2023

Primary Completion (Actual)

October 7, 2025

Study Completion (Actual)

October 7, 2025

Study Registration Dates

First Submitted

November 3, 2022

First Submitted That Met QC Criteria

December 1, 2022

First Posted (Actual)

December 5, 2022

Study Record Updates

Last Update Posted (Actual)

April 27, 2026

Last Update Submitted That Met QC Criteria

April 24, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

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

No

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on Alcohol Use Disorder

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