GamblingBLUNDERNCT02862821
Biomarkers of Online Gambling Addiction
A study testing HR-EEG in people with Gambling, run by Centre Hospitalier Universitaire de Besancon.
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.
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 group | Role | What they receive |
|---|---|---|
| validation of EEfRT task | Experimental | 20 healthy volunteers will be recruted to validate motivation EEfRT task which is adaptated to HR-EEG Receives: Other: HR-EEG |
| biomarkers identification | Experimental | 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). Receives: Other: HR-EEG |
| biomarkers validation | Experimental | 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). Receives: Other: HR-EEG |
What is being measured
The primary outcome is the main question the study is designed to answer.
average activation for each functional neuroimaging examination
Measured: day 7 ; day 14
Secondary outcomes (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.
- First posted11 Aug 2016 (estimated)
- Study startSep 2016
- Primary completionJul 2019 (estimated)
- Study completionJul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GamblingStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julie GIUSTINIANI, MD, Principal investigator, University Hospital of Besancon
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
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarkers of Online Gambling Addiction: Biomarqueurs de la dépendance Aux Jeux d'Argent en Ligne
- ClinicalTrials.gov ID
- NCT02862821
- Acronym / sponsor ID
- BLUNDER / P/2016/292
- Conditions
- Gambling
- Keywords
- biomarkers of psychiatric disorder, gambling addiction, high resolution-ElectroEncephaloGraphy (HR-EEG)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 73 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Jul 2019 (estimated)
- Study completion
- Jul 2019 (estimated)
- First posted
- 11 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| validation of EEfRT task | Experimental | Other: HR-EEG20 healthy volunteers will be recruted to validate motivation EEfRT task which is adaptated to HR-EEG |
| biomarkers identification | Experimental | Other: HR-EEG20 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). |
| biomarkers validation | Experimental | Other: HR-EEG13 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). |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (3 listed)
- left-handed
- female
- stage 1 and 2: other addictive pathology excepted tobacco and caffeine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HR-EEG | Other | biomarkers identification, biomarkers validation, validation of EEfRT task |
Primary outcome
average activation for each functional neuroimaging examination
Time frame: day 7 ; day 14
1 secondary outcome
correlations between various examinations and strength of neuronal response
Time frame: day 7 ; day 14
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2016.
- Background: PubMed 26086196Giustiniani 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julie GIUSTINIANI, MD principal investigator
University Hospital of Besancon
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.