Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2025-12-25 @ 4:18 AM
NCT ID:
NCT03793920
Eligibility Criteria:
Inclusion Criteria:
* Man or woman aged between 18 and 60 years
* Able to understand and to speak French
* Able to understand Note of information and to sign consent form
* Available health insurance
* Normal (or corrected to normal) vision and audition
* For women: Negative pregnancy test or menopausal for at least one year
* For Group 1 only : PEA criteria and no alcohol consumption within the three days preceding the experiment.
* For Group 2 only : PEA criteria, diagnosed with severe alcohol addiction and currently abstinent (for at least 15 days).
* For Group 3 only : Non-alcohol-dependent controls. No alcohol consumption within the three days preceding the experiment and father diagnosed with severe alcohol addiction.
* For Group 4 only : Non-alcohol-dependent controls. No alcohol consumption within the three days preceding the experiment.
Exclusion Criteria:
* Refusal of participation after clear and fair information on the study.
* Visual or auditory sensory disability to participate in the study.
* Benzodiazepines and / or Antipsychotic concomitant treatment.
* History of (or current) neurologic disease
* History of (or current) psychiatric disorder (apart alcohol-dependence for the PEA-alcohol-dependent group)
* Psychoactive Substance Use or Abuse other than tobacco and alcohol.
* Pregnant or breast-feeding women.
* Underage (\<18 yo) or adults under guardianship, judicial protection, or deprived of liberty.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT03793920
Study Brief:
Protocol Section:
NCT03793920