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Behavioral Addictions and Related NeuroCOgnitive Aspects (BANCO2)

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ClinicalTrials.gov Identifier: NCT03967418
Recruitment Status : Recruiting
First Posted : May 30, 2019
Last Update Posted : October 1, 2019
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital

Brief Summary:

Improving knowledge about behavioural addictions is a real public health issue. The etiopathogenic model of behavioural addictions is multifactorial, with various risk and vulnerability factors, involved in the initiation and maintenance of the disorders. Among these factors, neurocognitive alterations associated with behavioural addictions has recently aroused interest among researchers.

To our knowledge, there is no work wich compared several behavioural addictions with each other on a neurocognitive level. Moreover, neurocognitive data concerning certain behavioural addictions (such as sexual addiction) is almost non-existent. However, understanding the neurocognitive profiles of these patients would allow the investigators, on the one hand, to reinforce the existing literature and improve our understanding of the global process of addiction, and on the other hand, to propose alternative approaches to its management, taking into account the neurocognitive difficulties of the patients.

The investigators therefore propose to explore the neurocognitive alterations of patients suffering from several behavioural addiction (sexual addiction, excessive use of video games and eating disorders with bulimia episodes), by comparing them with each other, to matched healthy control groups and to a recognized behavioural addiction (gambling disorder; data from the BANCO study - NCT03202290).


Condition or disease Intervention/treatment Phase
Behavioral Addiction Behavioral: Cognitive and clinical assessment Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Study BANCO2: Behavioral Addictions and Related NeuroCOgnitive Aspects : Monocentric, Prospective, Controlled, Open-label Study Conducted With a Sample of Patients With Behavioural Addiction
Estimated Study Start Date : October 2019
Estimated Primary Completion Date : October 2022
Estimated Study Completion Date : October 2022

Arm Intervention/treatment
Patients with behavioral addictions
Patients suffering from behavioural addiction (sexual addiction, excessive use of video games and eating disorders with bulimia episodes) will be recruited
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, psychiatric and addictive comorbidities)

Healthy volunteers
Healthy volunteers will be matched on gender, age and education level to patients
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, psychiatric and addictive comorbidities)




Primary Outcome Measures :
  1. Scores obtained at the various neurocognitive tests used [ Time Frame: 4 hours ]
    A composite score will be created to reflect the overall level of cognitive performance of individuals with behavioral addictions, compared to healthy controls



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria for all participants:

  • Adults
  • Mastering the French language
  • Social Security Affiliates
  • Having given consent
  • Correct level of vision allowing the reading of instructions, the distinction of shapes and colours and the understanding of shapes and images presented in cognitive tasks (subjectively attested by the patient)
  • Correct hearing level, allowing a good understanding of the sounds presented (subjectively attested by the patient and the assessor at the first contact for eligibility)

Inclusion criteria for patients:

  • Suffering from one of the behavioural addiction explored
  • Beginning treatment in the Addictology department of the University Hospital of Nantes

Inclusion criteria for healthy volunteers:

- Free from the explored behavioural addictions

Exclusion Criteria for all participants:

  • Current and not stabilized psychiatric and addictive disorders (mood disorders, anxiety disorders and substance-use disorders except nicotine, lifetime psychotic syndrome), diagnosed by the MINI and after consultation with the clinician,
  • Non stabilized endocrine disorders
  • Neurological disorders (such as head trauma, neurodegenerative diseases, unbalanced epilepsy, mental retardation, etc.),
  • Taking a psychotropic treatment wich is not stabilized for at least 2 weeks,
  • Consumption of a psychoactive substance - other than nicotine - within the 12 hours prior to the assessment,
  • Color blindness
  • Cardiac problems self-reported by the patient, in order to avoid bias in the measurement of cardiac parameters,
  • Electrical implants as declared by the participant (to avoid measurement artifacts)
  • Having benefited from current or past cognitive remediation program
  • Reporting being pregnant or breastfeeding
  • Current participation or in the past month in a pharmacological research protocol
  • Presenting difficulties for reading or writing French
  • Being under guardianship
  • With significant cognitive impairment not compatible with de cognitive assessment

Exclusion criteria for healthy volunteers :

- Suffering from one of the behavioural addiction explored


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03967418


Contacts
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Contact: Marie GRALL BRONNEC, Pr 02 40 84 76 20 marie.bronnec@chu-nantes.fr
Contact: Gaëlle CHALLET-BOUJU, PhD 02 40 84 76 20 gaelle.bouju@chu-nantes.fr

Locations
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France
CHU de Nantes Recruiting
Nantes, France, 44093
Contact: Marie GRALL BRONNEC, Pr         
Principal Investigator: Marie GRALL BRONNEC, Pr         
Sponsors and Collaborators
Nantes University Hospital
Investigators
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Principal Investigator: Marie GRALL BRONNEC, Pr CHU de Nantes

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Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT03967418     History of Changes
Other Study ID Numbers: RC19_0177
First Posted: May 30, 2019    Key Record Dates
Last Update Posted: October 1, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nantes University Hospital:
Behavioral addiction
neurocognition
neuropsychology
sexual addiction
internet gaming disorder
eating disorders
Additional relevant MeSH terms:
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Behavior, Addictive
Compulsive Behavior
Impulsive Behavior