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Biomarkers of Online Gambling Addiction (BLUNDER)

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ClinicalTrials.gov Identifier: NCT02862821
Recruitment Status : Not yet recruiting
First Posted : August 11, 2016
Last Update Posted : August 11, 2016
Sponsor:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment
Gambling Other: HR-EEG

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 73 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Biomarkers of Online Gambling Addiction: Biomarqueurs de la dépendance Aux Jeux d'Argent en Ligne
Study Start Date : September 2016
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: validation of EEfRT task
20 healthy volunteers will be recruted to validate motivation EEfRT task which is adaptated to HR-EEG
Other: HR-EEG
Experimental: biomarkers identification
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).
Other: HR-EEG
Experimental: biomarkers validation
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).
Other: HR-EEG


Outcome Measures

Primary Outcome Measures :
  1. average activation for each functional neuroimaging examination [ Time Frame: day 7 ; day 14 ]

Secondary Outcome Measures :
  1. correlations between various examinations and strength of neuronal response [ Time Frame: day 7 ; day 14 ]
    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.


Eligibility Criteria

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02862821


Contacts
Contact: Julie GIUSTINIANI, MD +33381219007 jgiustiniani@chu-besancon.fr
Contact: Magali NICOLIER, PhD +33381219007 mnicolier@chu-besancon.fr

Sponsors and Collaborators
Centre Hospitalier Universitaire de Besancon
Investigators
Principal Investigator: Julie GIUSTINIANI, MD University Hospital of Besancon
More Information

Publications:
Responsible Party: Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier: NCT02862821     History of Changes
Other Study ID Numbers: P/2016/292
First Posted: August 11, 2016    Key Record Dates
Last Update Posted: August 11, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Centre Hospitalier Universitaire de Besancon:
biomarkers of psychiatric disorder
gambling addiction
high resolution-ElectroEncephaloGraphy (HR-EEG)

Additional relevant MeSH terms:
Behavior, Addictive
Gambling
Compulsive Behavior
Impulsive Behavior
Disruptive, Impulse Control, and Conduct Disorders
Mental Disorders