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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02873572
Other study ID # N/2009/54
Secondary ID
Status Recruiting
Phase N/A
First received August 12, 2016
Last updated August 16, 2016
Start date April 2010
Est. completion date December 2017

Study information

Verified date August 2016
Source Centre Hospitalier Universitaire de Besancon
Contact Emmanuel Haffen, MD PhD
Phone +33381219007
Email emmanuel.haffen@univ-fcomte.fr
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: Committee for the Protection of Personnes
Study type Interventional

Clinical 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. 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).


Recruitment information / eligibility

Status Recruiting
Enrollment 80
Est. completion date December 2017
Est. primary completion date December 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 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)

Exclusion Criteria:

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label


Related Conditions & MeSH terms


Intervention

Behavioral:
step 1: online assessment
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/gamers
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).

Locations

Country Name City State
France CHU Besancon Besancon

Sponsors (2)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Besancon Saint Anne's Hospital

Country where clinical trial is conducted

France, 

References & Publications (1)

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 2 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Compare the average activation differences in each arm regarding the dependance level and between the 4 arms. up to 4 weeks No
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