NCT06122298

Brief Summary

Background The nature and direction of dysfunctional reward processing in gambling disorder remains unclear. We aim to test a novel neurobiological model of gambling addiction, that takes into account inter-individual differences, as well as the multifactorial nature of gaming addiction. Objectives Primary objective: This project will test the hypothesis that there are two opposite brain phenotypes that characterize two distinct subpopulations of gamblers, so-called impulsive vs. emotional, respectively. Secondary objective: This project will also seek to determine whether the brain phenotypes proposed above are capable of predicting gambling behavior outside the laboratory. Study design The primary objective will be tested using a reward task and a facial emotion recognition task performed by participants in an fMRI scanner. The secondary objective will be tested by combining fMRI measures with behavioral measures from everyday life collected via Ecological Momentary Assessment (EMA). Study population This study will focus on individuals with gambling problems, as well healthy subjects with no gambling problems and no psychiatric comorbidities. Outcomes/Endpoints Primary endpoint: We will compare striatum and amygdala reactivity between the three groups of impulsive gamblers, emotional gamblers and healthy subjects. Secondary endpoint: We will assess the correlation between emotional states and gambling behavior in everyday life, based on striatum and amygdala reactivity, using multiple linear regression models.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
25mo left

Started Mar 2024

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
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 Progress51%
Mar 2024May 2028

First Submitted

Initial submission to the registry

September 28, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 8, 2023

Completed
5 months until next milestone

Study Start

First participant enrolled

March 27, 2024

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2028

Last Updated

July 17, 2025

Status Verified

July 1, 2025

Enrollment Period

3.1 years

First QC Date

September 28, 2023

Last Update Submit

July 16, 2025

Conditions

Keywords

gambling addictionfMRIrewardemotionstriatumamygdalaEMA

Outcome Measures

Primary Outcomes (1)

  • Striatal BOLD response to reward outcomes and amygdala BOLD response to emotional stimuli

    Striatal BOLD response: average BOLD signal as measured with fMRI in the striatum in response to monetary reward outcomes in a gambling task. amygdala BOLD response: average BOLD signal as measured with fMRI in the amygdala in response to emotional faces in a facial emotion recognition task.

    4 weeks

Secondary Outcomes (1)

  • Correlation between emotional states and gambling behavior in everyday life

    4 weeks

Study Arms (2)

Individuals with gambling problems

This group includes individuals suffering from gambling addiction as defined by the DSM-5, and individuals suffering from "problem gambling", just below the DSM-5 diagnostic threshold.

Other: fMRIOther: Ecological Momentary Assessment

Healthy control individuals

Matched healthy individuals

Other: fMRI

Interventions

fMRIOTHER

A brain imaging technique that measures in vivo the activity of brain areas by detecting local changes in blood flow.

Healthy control individualsIndividuals with gambling problems

studies people's thoughts and behaviour in their daily lives by repeatedly collecting data in an individual's normal environment, at or close to the time they carry out that behaviour

Also known as: EMA
Individuals with gambling problems

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Two groups: 60 individuals with gambling problems (i.e. Number of DSM-5 critera for gambling disorder ≥3) and 60 matched healthy controls

You may qualify if:

  • For all participants (gamblers and healthy subjects)
  • Aged between 18 and 65
  • Fluent French, read and spoken
  • Male and Female
  • Informed consent to take part in the research
  • For gamblers :
  • Number of DSM-5 critera for gambling disorder ≥3
  • Score ≥ 5 on the Problem Gambling Severity Index questionnaire (PGSI)
  • Have a smartphone
  • For healthy subjects :
  • no DSM-5 criteria for gambling addiction
  • Score ≤ 2 on the Problem Gambling Severity Index questionnaire (PGSI)

You may not qualify if:

  • For all participants (gamblers and healthy subjects):
  • Contra-indication to MRI
  • Protected Adults
  • Breast feeding or pregnant women
  • Neurological disorder or severe chronic illness (diabetes, heart disease, kidney disease, lung disease or liver disease, inflammatory disease….)
  • Pharmacological treatment with psychotropic action (\>1 time / week)
  • Regular drug use (\> 1 time/ week for at least 3 months in the last 6 months)
  • Positive urine drug test on the day of the MRI sessions
  • For gamblers:
  • Psychiatric treatment \> 1 month (pharmacological or CBT)
  • Other DSM-5 diagnosis : schizophrenia, bipolar disorder, ADHD, autism, current PTSD, eating disorders, current major depressive episode, anxiety disorder, substance use disorder except nicotine, obsessive compulsive disorder.
  • For healthy subjects :
  • \- Any DSM-5 diagnosis except nicotine addiction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CH le Vinatier

Bron, 69678, France

RECRUITING

MeSH Terms

Conditions

Gambling

Interventions

Ecological Momentary Assessment

Condition Hierarchy (Ancestors)

Risk-TakingBehaviorDisruptive, Impulse Control, and Conduct DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Psychological TestsBehavioral Disciplines and Activities

Study Officials

  • Guillaume SESCOUSSE, PHD

    CH Le Vinatier

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

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

Study Record Dates

First Submitted

September 28, 2023

First Posted

November 8, 2023

Study Start

March 27, 2024

Primary Completion (Estimated)

May 20, 2027

Study Completion (Estimated)

May 20, 2028

Last Updated

July 17, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations