GamingGambleMMOReNCT02873572
Vulnerability Markers in Pathological Gambling
A study testing step 1: online assessment and step2: biomarkers of gamblers/gamers in people with Gaming and Gambling, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial summary
Addictions without substances are an emergent problem giving rise to a recent and increasing request of care. Among these new addictions, pathological gambling and pathological online video gaming which are up. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- What is being tested?
- step 1: online assessment and step2: biomarkers of gamblers/gamers
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2010to Dec 2017
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- arm 1: online poker gamblers who don't play another type of gamble/game
- arm 2: casino gamblers who don't play another type of gamble/game
- arm 3: MMORPG gamers who don't play another type of gamble/game
- arm 4: no-gamblers/gamers subjects
- step 2 : only right-handled subjects (due to registration of brain activity)
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU Besancon
Besançon, 25000
Magali Nicolier, PhD, +33381219007, mnicolier@chu-besancon.fr
Emmanuel Haffen, MD PhD
About this study
Official title: Marqueurs de vulnérabilité Aux Jeux Pathologiques
Addictions without substances are an emergent problem giving rise to a recent and increasing request of care. Among these new addictions, pathological gambling and pathological online video gaming which are up. The purpose of this study is to identify vulnerability factors (personality traits, decision making strategies...), which are common or specific to each type of game (on line poker, casino, MMORPG, and no-gamers).
- Being tested
- step 1: online assessment, step2: biomarkers of gamblers/gamers
- Keywords
- Online poker, Casino, Massively Multiplayer Online Role-Playing Game (MMORPG), Iowa Gambling Task (IGT), 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.
step 1: online assessmentBehavioural
Anonymous psychiatric and behavioral assessments to evaluate in particular addiction or pathological gambling/gaming and behavioral profile of gamblers/gamers. Once questionnaire completed, if the subjects want to continue to participate, they sent their email to investigators.
step2: biomarkers of gamblers/gamersBehavioural
For each arm, subjects were divided into 2 groups: dependant or not dependant gamblers/gamers. Investigators focused on decision-making biomarkers following the following flow-chart:
- psychiatric assesment and
- registration of brain activity during a decision-making task in conditions of uncertainty (IGT) with its version for HR-EEG validated by investigators (Giustiniani, 2015).
| Study group | Role | What they receive |
|---|---|---|
| online poker gamblers | Experimental | Recruitment by forums of online poker gamblers: an explanation of the research is sent with the dedicated link of the research. Receives: Behavioral: step 1: online assessment; Behavioral: step2: biomarkers of gamblers/gamers |
| casino gamblers | Experimental | Recruitment to the casino gates: an explanation of the research is sent with the dedicated e-link of the research and they could answer directly to the questionnaire (1st step) on sites. Receives: Behavioral: step 1: online assessment; Behavioral: step2: biomarkers of gamblers/gamers |
| MMORPG gamers | Experimental | Recruitment by forums of MMORPG (as guilds): an explanation of the research is sent with the dedicated link of the research. Receives: Behavioral: step 1: online assessment; Behavioral: step2: biomarkers of gamblers/gamers |
| no gamer subjects | Experimental | Recruitment by poster. Receives: Behavioral: step 1: online assessment; Behavioral: step2: biomarkers of gamblers/gamers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the average activation differences in each arm regarding the dependance level and between the 4 arms.
Measured: up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2016 (estimated)
- Study startApr 2010
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (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 GamingStudies of the same condition, open and under way.
- 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
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Collaborators
- Saint Anne's Hospital
- Responsible party
- Sponsor
- Investigators
- Philip Gorwood, MD PhD, Principal investigator, Saint Anne's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02873572
- Sponsor's protocol ID
- N/2009/54
- Acronym
- GambleMMORe
- Status last verified
- Aug 2016
- First submitted
- 12 Aug 2016
- Last updated
- 19 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 19 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Marqueurs de vulnérabilité Aux Jeux Pathologiques
- ClinicalTrials.gov ID
- NCT02873572
- Acronym / sponsor ID
- GambleMMORe / N/2009/54
- Keywords
- Online poker, Casino, Massively Multiplayer Online Role-Playing Game (MMORPG), Iowa Gambling Task (IGT), High Resolution Electroencephalography (HR-EEG)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Collaborators
- Saint Anne's Hospital
- Study start
- Apr 2010
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 19 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.
Addictions without substances are an emergent problem giving rise to a recent and increasing request of care. Among these new addictions, pathological gambling and pathological online video gaming which are up. The purpose of this study is to identify vulnerability factors (personality traits, decision making strategies...), which are common or specific to each type of game (on line poker, casino, MMORPG, and no-gamers).
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| online poker gamblers | Experimental | Behavioral: step 1: online assessment, Behavioral: step2: biomarkers of gamblers/gamersRecruitment by forums of online poker gamblers: an explanation of the research is sent with the dedicated link of the research. |
| casino gamblers | Experimental | Behavioral: step 1: online assessment, Behavioral: step2: biomarkers of gamblers/gamersRecruitment to the casino gates: an explanation of the research is sent with the dedicated e-link of the research and they could answer directly to the questionnaire (1st step) on sites. |
| MMORPG gamers | Experimental | Behavioral: step 1: online assessment, Behavioral: step2: biomarkers of gamblers/gamersRecruitment by forums of MMORPG (as guilds): an explanation of the research is sent with the dedicated link of the research. |
| no gamer subjects | Experimental | Behavioral: step 1: online assessment, Behavioral: step2: biomarkers of gamblers/gamersRecruitment by poster. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- arm 1: online poker gamblers who don't play another type of gamble/game
- arm 2: casino gamblers who don't play another type of gamble/game
- arm 3: MMORPG gamers who don't play another type of gamble/game
- arm 4: no-gamblers/gamers subjects
- step 2 : only right-handled subjects (due to registration of brain activity)
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| step 1: online assessmentAnonymous psychiatric and behavioral assessments to evaluate in particular addiction or pathological gambling/gaming and behavioral profile of gamblers/gamers. Once questionnaire completed, if the subjects want to continue to participate, they sent their email to investigators. | Behavioural | MMORPG gamers, casino gamblers, no gamer subjects, online poker gamblers |
| step2: biomarkers of gamblers/gamersFor each arm, subjects were divided into 2 groups: dependant or not dependant gamblers/gamers. Investigators focused on decision-making biomarkers following the following flow-chart: * psychiatric assesment and * registration of brain activity during a decision-making task in conditions of uncertainty (IGT) with its version for HR-EEG validated by investigators (Giustiniani, 2015). | Behavioural | MMORPG gamers, casino gamblers, no gamer subjects, online poker gamblers |
Primary outcome
Compare the average activation differences in each arm regarding the dependance level and between the 4 arms.
Time frame: up to 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2016.
- Results publication: 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.
Philip Gorwood, MD PhD principal investigator
Saint Anne's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing step 1: online assessment and step2: biomarkers of gamblers/gamers in people with Gaming and Gambling, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
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 5 inclusion and 1 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 19 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Emmanuel Haffen, MD PhD (+33381219007, emmanuel.haffen@univ-fcomte.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare the average activation differences in each arm regarding the dependance level and between the 4 arms. (time frame: up to 4 weeks). 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 NCT02873572, 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 19 Aug 2016.