Behavioral Addiction Clinical Trial
— BANCO2Official title:
Study BANCO2: Behavioral Addictions and Related NeuroCOgnitive Aspects : Monocentric, Prospective, Controlled, Open-label Study Conducted With a Sample of Patients With Behavioural Addiction
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).
| Status | Recruiting |
| Enrollment | 180 |
| Est. completion date | October 2022 |
| Est. primary completion date | October 2022 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 15 Years and older |
| Eligibility |
Inclusion Criteria for all participants: - More than 15 years and 3 months old - 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 |
| Country | Name | City | State |
|---|---|---|---|
| France | CHU de Nantes | Nantes |
| Lead Sponsor | Collaborator |
|---|---|
| Nantes University Hospital |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Scores obtained at the various neurocognitive tests used | A composite score will be created to reflect the overall level of cognitive performance of individuals with behavioral addictions, compared to healthy controls | 4 hours |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05434429 -
Mobile Health for Problematic Behaviors and Substance Use
|
N/A |