NCT02862821

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
73

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2016

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 20, 2016

Completed
22 days until next milestone

First Posted

Study publicly available on registry

August 11, 2016

Completed
21 days until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

August 11, 2016

Status Verified

August 1, 2016

Enrollment Period

2.8 years

First QC Date

July 20, 2016

Last Update Submit

August 10, 2016

Conditions

Keywords

biomarkers of psychiatric disordergambling addictionhigh resolution-ElectroEncephaloGraphy (HR-EEG)

Outcome Measures

Primary Outcomes (1)

  • average activation for each functional neuroimaging examination

    day 7 ; day 14

Secondary Outcomes (1)

  • correlations between various examinations and strength of neuronal response

    day 7 ; day 14

Study Arms (3)

validation of EEfRT task

EXPERIMENTAL

20 healthy volunteers will be recruted to validate motivation EEfRT task which is adaptated to HR-EEG

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).

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).

Other: HR-EEG

Interventions

HR-EEGOTHER
biomarkers identificationbiomarkers validationvalidation of EEfRT task

Eligibility Criteria

Age18 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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 2015.

    PMID: 26086196BACKGROUND

MeSH Terms

Conditions

Gambling

Condition Hierarchy (Ancestors)

Risk-TakingBehaviorDisruptive, Impulse Control, and Conduct DisordersMental Disorders

Study Officials

  • Julie GIUSTINIANI, MD

    University Hospital of Besancon

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Julie GIUSTINIANI, MD

CONTACT

Magali NICOLIER, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 20, 2016

First Posted

August 11, 2016

Study Start

September 1, 2016

Primary Completion

July 1, 2019

Study Completion

July 1, 2019

Last Updated

August 11, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share