NCT07593664

Brief Summary

The goal of this study is to validate the virtual version of the Multiple Errands Test (V-MET) as a tool for assessing executive functions in patients with alcohol use disorder (AUD). More specifically, the project aims to:

  1. 1.evaluate if the performance in the virtual version of the test is related to the performance in the original test in patients with AUD.
  2. 2.establish whether the virtual version of the test is sensitive enough to detect patients with or without an executive function deficit.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
24mo left

Started May 2026

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

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

Study Progress3%
May 2026Jun 2028

Study Start

First participant enrolled

May 1, 2026

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

May 12, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 18, 2026

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2028

Last Updated

May 20, 2026

Status Verified

May 1, 2026

Enrollment Period

2.1 years

First QC Date

May 12, 2026

Last Update Submit

May 18, 2026

Conditions

Keywords

Multiple Errands TestExecutive functionsVirtual realityAlcohol Use Disorder

Outcome Measures

Primary Outcomes (1)

  • Total number of errors on the test

    Total number of errors on the MET and the V-MET. Errors include: * Inefficiencies (a more effective action could have been made) * Rule breaks: a specific rule is broken * Interpretation failure (the task is misunderstood or misinterpreted) * Task failure: not carried out or not completely completed

    Baseline

Secondary Outcomes (4)

  • Inefficiencies on the test

    Baseline

  • Rule breaks on the test

    Baseline

  • Interpretation failures on the test

    Baseline

  • Task failures on the test

    Baseline

Study Arms (3)

AUD group with executive function deficit

EXPERIMENTAL

Group of patients with alcohol use disorder and a deficit in executive functions as assessed by the Frontal Assessment Battery

Behavioral: Multiple Errand Test (MET)Behavioral: Virtual MET

AUD group without executive function deficit

ACTIVE COMPARATOR

Group of patients with alcohol use disorder but without a deficit in executive functions as assessed by the Frontal Assessment Battery

Behavioral: Multiple Errand Test (MET)Behavioral: Virtual MET

Control group

ACTIVE COMPARATOR

Group of healthy volunteers

Behavioral: Multiple Errand Test (MET)Behavioral: Virtual MET

Interventions

The test takes place in a real supermarket. Participants must complete a list of tasks (e.g., purchasing certain items, collecting some information) while adhering to rules (e.g., not visiting the same place twice, etc).

AUD group with executive function deficitAUD group without executive function deficitControl group
Virtual METBEHAVIORAL

The test takes place in a virtual supermarket, developed on the C2Neuro app by C2CARE®. Participants must complete a similar list of tasks to the MET (e.g., purchasing certain items, collecting some information) and adhere to similar to rules (e.g., not visiting the same place twice, etc) .

AUD group with executive function deficitAUD group without executive function deficitControl group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • written consent
  • Normal or corrected vision and hearing
  • Membership or entitlement to a social security plan
  • spoken and written French
  • third party liability insurance
  • for patients only :
  • at least 6 criteria for AUD based on the Diagnostic and statistical manual of mental disorders
  • At the end of withdrawal: treatment with a diazepam equivalent of ≤ 20 mg/day

You may not qualify if:

  • under tutorship/ judicial protection
  • Sensory or motor impairment (impeding the use of virtual reality and/or mobility)
  • Severe neurological disorder (such as dementia or Korsakoff's syndrome)
  • Photosensitive epilepsy (contraindication for the use of virtual reality)
  • Any other condition deemed incompatible with the study, at the investigator's discretion
  • Montreal Cognitive Assessment (MoCA) score \< 10 (severe cognitive impairment)
  • Breastfeeding or pregnant women
  • Familiarity with the supermarket visited during the MET test
  • For controls only :
  • History of alcohol use disorder
  • score ≥ 8 on the Alcohol Use Disorders Identification Test
  • Score on the Frontal Assessment Battery \< 16 (or \< 15 if education is below secondary level)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CH Le Vinatier

Bron, 69500, France

Location

Hôpital de la Croix Rousse

Lyon, 69004, France

Location

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Christophe ICARD, MD

    CH Le Vinatier

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 12, 2026

First Posted

May 18, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

June 1, 2028

Last Updated

May 20, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will share

Individual participant data (IPD) underlying the results reported in this study might be shared, including de-identified demographic data, baseline characteristics, outcome measures, and variables necessary to reproduce the analyses. All data will be fully anonymized to protect participant confidentiality. A data dictionary and relevant metadata might also be provided to facilitate interpretation and reuse. The analytic code will be provided at the time of publication of the primary study results. De-identified IPD will be shared via an open science repository such as Open Science Framework and may also be made available upon request.

Shared Documents
ANALYTIC CODE
Time Frame
Data and supporting documents will be available beginning at the time of publication of the primary results
Access Criteria
Data will be made openly available

Locations