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Biomarkers of Online Gambling Addiction (BLUNDER)

Primary Purpose

Gambling

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
HR-EEG
Sponsored by
Centre Hospitalier Universitaire de Besancon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Gambling focused on measuring biomarkers of psychiatric disorder, gambling addiction, high resolution-ElectroEncephaloGraphy (HR-EEG)

Eligibility Criteria

18 Years - 40 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • right-handed
  • stage 1: healthy volunteers (no online poker gamblers and no-addict (excepted tobacco and caffeine))
  • stage 2 : 20 addict-online pokers gamblers and 20 non addict online pokers gamblers (according to ICJE criteria)
  • stage 3 : 13 online poker gamblers (independently of their dependence level)

Exclusion Criteria:

  • left-handed
  • female
  • stage 1 and 2: other addictive pathology excepted tobacco and caffeine

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Experimental

    Arm Label

    validation of EEfRT task

    biomarkers identification

    biomarkers validation

    Arm Description

    20 healthy volunteers will be recruted to validate motivation EEfRT task which is adaptated to HR-EEG

    20 addict online poker gamblers and 20 non-addict online poker gamblers will be recruted : After standardized questionnaires to define the socio-demographic data, the diagnosis of gambling addiction (Diagnostic and Statistical Manual of Mental Disorder 5th edition DSM-5), screening for comorbidities addictive, the level of anxiety and impulsivity, brain acvtivity will be registred (by randomisation between the 2 tasks) with HR-EEG: during the performance of a task of motivation evaluation laboratory (EEfRT) adaptated for high-resolution electroencephalography AND during a laboratory task that assesses decision making in conditions of uncertainty (IGT) with its version for high-resolution electroencephalography has already been validated in a previous study (Giustiniani et al., 2015).

    13 online poker gamblers will be recruted, independently of their dependance profile and they will realize the same task that in precedent arm (quaestionnaires and 2 tasks adaptated to HR-EEG).

    Outcomes

    Primary Outcome Measures

    average activation for each functional neuroimaging examination

    Secondary Outcome Measures

    correlations between various examinations and strength of neuronal response
    a subject-by-subject analysis of each brain activation will be conducted to look for correlations between the various examinations and strength of neuronal response.

    Full Information

    First Posted
    July 20, 2016
    Last Updated
    August 10, 2016
    Sponsor
    Centre Hospitalier Universitaire de Besancon
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02862821
    Brief Title
    Biomarkers of Online Gambling Addiction
    Acronym
    BLUNDER
    Official Title
    Biomarkers of Online Gambling Addiction: Biomarqueurs de la dépendance Aux Jeux d'Argent en Ligne
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 2016 (undefined)
    Primary Completion Date
    July 2019 (Anticipated)
    Study Completion Date
    July 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Centre Hospitalier Universitaire de Besancon

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to identify alterations of motivational processes related to decision making in uncertainty condition associated with gambling addiction: by studying the dynamics between brain systems involved in decision making and motivation.
    Detailed Description
    Internet gaming is a major risk for the vulnerable in terms of risk of dependence, emergence of psychiatric disorders, financial consequences, and family. Addictions to games in France represent 1 to 2% of the general population. Online poker happens to be a specific form of gambling which has the fastest growing online games. If vulnerabilities factors have been reported in many studies, to date no biomarkers for screening people at risk are available. One of the favorite way in biomarker research concern impaired decision-making capacity biomarkers. In a previous work, investigators have shown that the decision was strongly linked to motivation and impaired decision-making capacity would be associated with a motivational dys-regulation (Giustiniani et al., 2015) . The search for biomarkers in parallel to the motivation of the decision making is essential and yet this day nonexistent in the literature. Here, with subjects addicted to online poker, a behavioral protocol developed to measure motivation in pathological populations (Effort-Expenditure for Rewards Task, EEfRT) will be used and will be specifically adapted to be studied by functional neuroimaging. The main objective is to identify alterations of motivational processes related to decision making in conditions of uncertainty associated with gambling addiction. For this purpose, the dynamics between brain systems involved in decision making and motivation will be studied. As a secondary objective, correlations between neural activity and performance to different tests used to measure decision making (Iowa Gambling Task IGT) and motivation (EEfRT) will be evaluated. Finally the influence of motivation level on the performance score to decision making task will be evaluated, the goal will be the development of an optimal strategy in terms of prevention. The study will be conducted at the University Hospital of Besancon during 36 months with 73 participants: The experiment will involve three stages: stage 1 : validation of HR-EEG adaptated motivation EEfRT task adaptated to HR-EEG by 20 healthy volunteers . stage 2: identification of biomarkers by 20 addict online poker gamblers and 20 non-addict online poker gamblers stage 3 : validation of previously identified biomarkers by 13 online poker gamblers recruted in poker forum. All stages progress according to the same plan: Standardized questionnaire to define the socio-demographic data, the diagnosis of gambling addiction (ICJE criteria (Indice Canadien fu Jeu Excessif), screening for comorbidities addictive, the level of anxiety and impulsivity. Registration of brain activity (randomisation): during the performance of a task of motivation evaluation laboratory (EEfRT) adaptated for high-resolution electroencephalography AND during a laboratory task that assesses decision making in conditions of uncertainty (IGT) with its version for high-resolution electroencephalography has already been validated in a previous study (Giustiniani et al., 2015). Statistical analysis will aim to compare the average activation differences between the two populations for each functional neuroimaging examination. Then a subject-by-subject analysis of each brain activation will be conducted to look for correlations between the various examinations and strength of neuronal response. Following this study, the results will allow us to identify biomarkers of addiction that will help improving vulnerable populations screening capabilities to tailor prevention strategies. Furthermore the identification of specific neural correlates dependence will adapt therapeutic strategies.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Gambling
    Keywords
    biomarkers of psychiatric disorder, gambling addiction, high resolution-ElectroEncephaloGraphy (HR-EEG)

    7. Study Design

    Primary Purpose
    Screening
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    73 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    validation of EEfRT task
    Arm Type
    Experimental
    Arm Description
    20 healthy volunteers will be recruted to validate motivation EEfRT task which is adaptated to HR-EEG
    Arm Title
    biomarkers identification
    Arm Type
    Experimental
    Arm Description
    20 addict online poker gamblers and 20 non-addict online poker gamblers will be recruted : After standardized questionnaires to define the socio-demographic data, the diagnosis of gambling addiction (Diagnostic and Statistical Manual of Mental Disorder 5th edition DSM-5), screening for comorbidities addictive, the level of anxiety and impulsivity, brain acvtivity will be registred (by randomisation between the 2 tasks) with HR-EEG: during the performance of a task of motivation evaluation laboratory (EEfRT) adaptated for high-resolution electroencephalography AND during a laboratory task that assesses decision making in conditions of uncertainty (IGT) with its version for high-resolution electroencephalography has already been validated in a previous study (Giustiniani et al., 2015).
    Arm Title
    biomarkers validation
    Arm Type
    Experimental
    Arm Description
    13 online poker gamblers will be recruted, independently of their dependance profile and they will realize the same task that in precedent arm (quaestionnaires and 2 tasks adaptated to HR-EEG).
    Intervention Type
    Other
    Intervention Name(s)
    HR-EEG
    Primary Outcome Measure Information:
    Title
    average activation for each functional neuroimaging examination
    Time Frame
    day 7 ; day 14
    Secondary Outcome Measure Information:
    Title
    correlations between various examinations and strength of neuronal response
    Description
    a subject-by-subject analysis of each brain activation will be conducted to look for correlations between the various examinations and strength of neuronal response.
    Time Frame
    day 7 ; day 14

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: right-handed stage 1: healthy volunteers (no online poker gamblers and no-addict (excepted tobacco and caffeine)) stage 2 : 20 addict-online pokers gamblers and 20 non addict online pokers gamblers (according to ICJE criteria) stage 3 : 13 online poker gamblers (independently of their dependence level) Exclusion Criteria: left-handed female stage 1 and 2: other addictive pathology excepted tobacco and caffeine
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Julie GIUSTINIANI, MD
    Phone
    +33381219007
    Email
    jgiustiniani@chu-besancon.fr
    First Name & Middle Initial & Last Name or Official Title & Degree
    Magali NICOLIER, PhD
    Phone
    +33381219007
    Email
    mnicolier@chu-besancon.fr
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Julie GIUSTINIANI, MD
    Organizational Affiliation
    University Hospital of Besancon
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    26086196
    Citation
    Giustiniani J, Gabriel D, Nicolier M, Monnin J, Haffen E. Neural Correlates of Successful and Unsuccessful Strategical Mechanisms Involved in Uncertain Decision-Making. PLoS One. 2015 Jun 18;10(6):e0130871. doi: 10.1371/journal.pone.0130871. eCollection 2015.
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    Biomarkers of Online Gambling Addiction

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