AzTrials
AzTrials

GamblingBLUNDERNCT02862821

Biomarkers of Online Gambling Addiction

A study testing HR-EEG in people with Gambling, run by Centre Hospitalier Universitaire de Besancon.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 40 years, men onlyHealthy volunteers can take part
Conditions the study is for
Gambling
What is being tested?
HR-EEG
Could I receive a placebo?
No, everyone receives an active treatment
How many people
73 participants
Where
No sites listed yet
Study dates
Sep 2016to Jul 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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)

Who cannot join

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

Trial locations and contacts

No sites are listed yet.

Julie GIUSTINIANI, MD contact

+33381219007

jgiustiniani@chu-besancon.fr

Magali NICOLIER, PhD contact

+33381219007

mnicolier@chu-besancon.fr

About this study

Official title: Biomarkers of Online Gambling Addiction: Biomarqueurs de la dépendance Aux Jeux d'Argent en Ligne

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.

Read the 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.

Conditions
Gambling
Being tested
HR-EEG
Keywords
biomarkers of psychiatric disorder, gambling addiction, high resolution-ElectroEncephaloGraphy (HR-EEG)
Medical subject headings
Gambling

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HR-EEGOther

Study groups in NCT02862821
Study groupRoleWhat they receive
validation of EEfRT taskExperimental20 healthy volunteers will be recruted to validate motivation EEfRT task which is adaptated to HR-EEG
Receives: Other: HR-EEG
biomarkers identificationExperimental20 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).
Receives: Other: HR-EEG
biomarkers validationExperimental13 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).
Receives: Other: HR-EEG

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. average activation for each functional neuroimaging examination

    Measured: day 7 ; day 14

Secondary outcomes (1)
  1. 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.

    Measured: day 7 ; day 14

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Aug 2016 (estimated)
  2. Study startSep 2016
  3. Primary completionJul 2019 (estimated)
  4. Study completionJul 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Screening
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
73 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02862821
Sponsor's protocol ID
P/2016/292
Acronym
BLUNDER
Status last verified
Aug 2016
First submitted
20 Jul 2016
Last updated
11 Aug 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 26086196

Questions about this trial

What is this clinical trial studying?

A study testing HR-EEG in people with Gambling, run by Centre Hospitalier Universitaire de Besancon.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 11 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Julie GIUSTINIANI, MD (+33381219007, jgiustiniani@chu-besancon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

average activation for each functional neuroimaging examination (time frame: day 7 ; day 14). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02862821, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2016.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in