Clinical trial NCT03818971: Study of Retinal Function Using Electroretinogram in Regular Alcohol Users
Official title: Study of Retinal Function Using Electroretinogram in Regular Alcohol Users
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Use Disorder
Keywords: retina AND electroretinogram
Lead sponsor: Centre Psychothérapique de Nancy
Sponsor class: OTHER
First posted: 2019-01-28
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: mono centric study, in parallel groups, controlled, non-randomized and open
Primary purpose: BASIC_SCIENCE

Brief summary: Alcohol is a major public health problem and its neurotoxic effects are, among other things, responsible for altering the functioning of cerebral neurotransmission pathways.

The retina is an anatomical and developmental extension of the central nervous system. It is composed of several layers of retinal neurons that share similar anatomical and functional properties with brain neurons. Retinal neurons are notably equipped with a complex system of neurotransmission constituted by the main neurotransmitters that are involved in the central effects of alcohol: glutamate, dopamine, serotonin ... The retina is used here as a site of indirect investigation for abnormal central neurotransmission pathways following regular alcohol use. It is recognized to date as a good site for investigating central abnormalities in neuropsychiatric and addictive disorders.

The objective of this project is to study the retinal function using electroretinogram (ERG) in regular alcohol users to isolate potential markers of cerebral neurotransmission abnormalities.


Eligibility criteria: For alcohol consumer with alcohol use disorder :

Inclusion Criteria:

* aged between 18 and 35 years
* alcohol use disorder according to the DSM 5
* affiliation to a social security scheme

Exclusion Criteria:

* psychoactive substance consumption (other than alcohol)
* psychiatric disease in progress according to the DSM 5
* neurologic disease in progress
* mental impairment making it difficult or impossible to participate to the study
* major under guardianship or curatorship or under safeguarding of justice
* pregnant women or feeding
* people in emergency situation
* participation to another interventional study
* retinal disease in progress
* chronic glaucoma
* ophtalmic disease affecting the visual acuity
* ocular infection in progress
* urinary positive drug check the day of the inclusion
* postive Breathalyser the day of the inclusion

Primary outcomes:
measure: modification of amplitude
timeFrame: Day 0 (=day of inclusion = the only visit of the study)
measure: modification of implicite time parameters
timeFrame: Day 0 (=day of inclusion = the only visit of the study)
measure: modification of amplitude of the oscillatory potential
timeFrame: Day 0 (=day of inclusion = the only visit of the study)
measure: modification of implicit time of the oscillatory potential
timeFrame: Day 0 (=day of inclusion = the only visit of the study)
measure: modification of amplitude of the background noise
timeFrame: Day 0 (=day of inclusion = the only visit of the study)
Secondary outcomes:
Other outcomes:
Locations:
city: Laxou
country: France
facility: Centre Psychothérapique de Nancy
state: Nancy
Study officials:
affiliation: Centre Psychothérapique de Nancy
name: Thomas SCHWITZER
role: PRINCIPAL_INVESTIGATOR
References: