BANCO Study: Behavioral Addictions and Related NeuroCOgnitive Aspects: A Monocentric, Prospective, Controlled, Open-label Study of a Sample of Patients With Gambling Disorder (BANCO)

September 11, 2018 updated by: Nantes University Hospital
The prevalence of people suffering from gambling disorder is relatively high, and the impact on this disorder the individual and those around him is considerable. The etiopathogenic model of gambling disorder is multifactorial, involving various risk and vulnerability factors, involved in the initiation and maintenance of the disorder. Among these factors, neurocognitive alterations associated with the disorder has recently aroused interest among researchers. In this study, the investigators propose to explore the neurocognitive impairments of patients suffering from gambling disorder compared to a control group, in order to identify alterations that could be the target of cognitive remediation programs. Gambling disorder provides a unique opportunity to study the specific neurocognitive impairments of the addictive process because it is not biased by the neurotoxic effect of substances as it is the case in substance use disorders.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Nantes, France, 44093
        • Recruiting
        • CHU de Nantes
        • Principal Investigator:
          • Marie GRALL BRONNEC, Pr
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • For the patients :

Aged of more than 18, Suffering from gambling disorder(diagnosis according to DSM-5), Patient starting care in the Addictology and Psychiatry department of the Nantes University Hospital, Mastering the French language, Social Security Affiliates, Having given consent

  • For the volunteers:

Aged of more than 18, Subject not suffering from gambling disorder, Mastering the French language, Social Security Affiliates Having given consent

Exclusion Criteria:

  • For patients :

Having psychiatric and addictive disorders (present and not stabilized mood disorders, anxiety disorders and substance-use disorders except nicotine, lifetime psychotic syndrome, diagnosed by the MINI and after consultation with the clinician), Unstable endocrine disruptions or neurological disorders (such as head trauma, neurodegenerative diseases, unbalanced epilepsy, mental retardation, etc.), Taking a non-stabilized psychotropic treatment for at least 2 weeks Consumption of a psychoactive substance - other than nicotine - within the 12 hours preceding the assessment, Presenting a score on the HAD questionnaire ≥ 11, Having benefited from a current or past RC program, Reporting to be pregnant or nursing, Current participation or in the past month in a pharmacological research protocol, Presenting difficulties for the reading or writing of the French language, Being under guardianship, Presenting disorders of higher functions

  • For volunteers:

Suffering from past or current pathological gambling (DSM-5 diagnosis), Having psychiatric and addictive disorders (mood disorders, anxiety disorders and disorders linked to the use of non-nicotine substance present and not stabilized, life-long psychotic syndrome, diagnosed by the MINI), endocrine or neurological disorders (Cranial trauma, neurodegenerative diseases, unbalanced epilepsy, mental retardation, etc.), Taking a non-stabilized psychotropic treatment for at least 2 weeks, Declaring to have consumed a psychoactive substance - other than nicotine - within the 12 hours preceding the assessment, Presenting a score on the HAD questionnaire ≥ 11, Having benefited from an assumption in current or past RC program, Reporting to be pregnant or nursing, Currently participating or in the past month to a pharmacological research protocol, Presenting difficulties for the reading or writing of the French language, Being under guardianship, Presenting disorders of cognitive functions

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Gambling disorder
patients suffering from gambling disorder
Behavioral: Cognitive and clinical assessment
The content of the assessment will be the same for all subjects and will consist of a cognitive assessment (neurocognition, social cognition, metacognition, emotional reactivity) and a clinical assessment (impulsivity, personality, psychriatric and addictive comorbidities)
Other: Controls
healthy controls
Behavioral: Cognitive and clinical assessment
The content of the assessment will be the same for all subjects and will consist of a cognitive assessment (neurocognition, social cognition, metacognition, emotional reactivity) and a clinical assessment (impulsivity, personality, psychriatric and addictive comorbidities)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean difference of the scores obtained at the various neurocognitive tests between the group of disordered gamblers and the group of healthy controls
Time Frame: 2.5 hours
2.5 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nantes University Hospital

Investigators

  • Principal Investigator: Marie GRALL BRONNEC, Pr, CHU de Nantes

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 24, 2018

Primary Completion (Anticipated)

August 1, 2020

Study Completion (Anticipated)

August 1, 2020

Study Registration Dates

First Submitted

June 27, 2017

First Submitted That Met QC Criteria

June 27, 2017

First Posted (Actual)

June 28, 2017

Study Record Updates

Last Update Posted (Actual)

September 12, 2018

Last Update Submitted That Met QC Criteria

September 11, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC17_0165

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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