NCT05636033

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 3, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 5, 2022

Completed
5 months until next milestone

Study Start

First participant enrolled

April 19, 2023

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 7, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 7, 2025

Completed
Last Updated

April 27, 2026

Status Verified

April 1, 2026

Enrollment Period

2.5 years

First QC Date

November 3, 2022

Last Update Submit

April 24, 2026

Conditions

Keywords

alcohol use disordersemantic associationsemantic networkscognition

Outcome Measures

Primary Outcomes (2)

  • Description of the semantic associations using FGAT

    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

    The Associative Judgment Task will be used in Alcohol use disorder patients and Healthy controls

    At baseline (T1)

Secondary Outcomes (16)

  • Impact of medications on the semantic association performance

    At baseline (T1)

  • Impact of age on the semantic association performance

    At baseline (T1)

  • Impact of the study level on the semantic association performance

    At baseline (T1)

  • Impact of gender on the semantic association performance

    At baseline (T1)

  • Impact of the duration of dependence on the semantic association performance

    At baseline (T1)

  • +11 more secondary outcomes

Study Arms (2)

Alcohol use disorder patients

Healthy controls

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • For alcohol use disorder patients
  • Severe alcohol use disorder
  • French as mother tongue
  • Right-hander
  • 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

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fernand Widal Hospital

Paris, Île-de-France Region, 75010, France

Location

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Alexandra Dereux, PH (MD)

    APHP

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 3, 2022

First Posted

December 5, 2022

Study Start

April 19, 2023

Primary Completion

October 7, 2025

Study Completion

October 7, 2025

Last Updated

April 27, 2026

Record last verified: 2026-04

Locations