Status:
UNKNOWN
Effects of Prenatal Alcohol Exposure on Emotional and Cognitive Abilities in Adults
Lead Sponsor:
University Hospital, Lille
Conditions:
Prenatal Alcohol Exposure
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
Hypothesis: Individuals presenting with prenatal alcohol exposure (PEA) show emotional abilities deficits, and imbalance between the two systems involved in decision-making according to dual-process ...
Detailed Description
Each participant will undergo 2 visits : First visit : * Checking inclusion and non-inclusion criteria * Note of information and consent form * Record of concomitant treatments and anamnestic elemen...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 8 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 11 2022
Estimated Enrollment :
144 Patients enrolled
Trial Details
Trial ID
NCT03793920
Start Date
November 8 2018
End Date
November 11 2022
Last Update
October 3 2022
Active Locations (2)
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1
CSAPA
Lille, France, 59037
2
CHRU Lille, Fontan2
Lille, France