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Completed

NCT Number: NCT03818971

Study of Retinal Function Using Electroretinogram in Regular Alcohol Users

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.

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Key information

Conditions

Alcohol Use Disorder Alcohol-Related Disorders Alcoholism Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Psychothérapique de Nancy

Laxou, Nancy, 54520, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

electroretinogram (flash, pattern and multifocal)

Other

we measured the waves a, b, oscillatory potentials, back ground noise and i for the flash ERG, the waves P50 and N95 for the pattern ERG and the P1, N1 and N2 for the multifocal ERG

Primary outcomes

  1. modification of amplitude

    Time frame: Day 0 (=day of inclusion = the only visit of the study)

    measured with flash electroretinogram and pattern electroretinogram / amplitude in microvolt

  2. modification of implicite time parameters

    Time frame: Day 0 (=day of inclusion = the only visit of the study)

    measured with flash electroretinogram and pattern electroretinogram - implicite time in millisecond

  3. modification of amplitude of the oscillatory potential

    Time frame: Day 0 (=day of inclusion = the only visit of the study)

    waves P1, P2, P3, P4 measured with flash electroretinogram - amplitude in microvolt

  4. modification of implicit time of the oscillatory potential

    Time frame: Day 0 (=day of inclusion = the only visit of the study)

    waves P1, P2, P3, P4 measured with flash electroretinogram - implicite time in millisecond

  5. modification of amplitude of the background noise

    Time frame: Day 0 (=day of inclusion = the only visit of the study)

    measured with the flash electroretinogram, flicker 3.0 sequence - amplitude in microvolt

Sponsors and collaborators

Lead sponsor

Centre Psychothérapique de Nancy

Other

Registry information

Acronym: ERICA

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jan 28, 2019
Registry last updated
Dec 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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