Study of Retinal Function Using Electroretinogram in Regular Alcohol Users (ERICA)

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.

Study Overview

• Status: Completed
• Conditions: Alcohol Use Disorder
• Intervention / Treatment: Other: electroretinogram (flash, pattern and multifocal)

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Nancy
    • Laxou, Nancy, France, 54520
      • Centre Psychothérapique de Nancy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: alcohol consumption with alcohol use disorder (AUD); subjects with regular alcohol consumption with AUD according to the DSM 5 without any other substance use disorder (except alcohol) without psychiatric, neurologic or ophthalmologic disease in progress with a negative drug check and Breathalyzer the day of the inclusion - only one visit is planned for this study : an electroretinogram will be realized	Other: electroretinogram (flash, pattern and multifocal); 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
Other: alcohol consumption without alcohol use disorder; subjects with regular alcohol consumption without AUD according to the DSM 5 without any other substance use disorder without psychiatric, neurologic or ophthalmologic disease in progress with a negative drug check and Breathalyzer the day of the inclusion - only one visit is planned for this study : an electroretinogram will be realized	Other: electroretinogram (flash, pattern and multifocal); 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
Other: no alcohol consumption; subjects without alcohol consumption without any other substance use disorder without psychiatric, neurologic or ophthalmologic disease in progress with a negative drug check and Breathalyzer the day of the inclusion - only one visit is planned for this study : an electroretinogram will be realized	Other: electroretinogram (flash, pattern and multifocal); 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
modification of amplitude	measured with flash electroretinogram and pattern electroretinogram / amplitude in microvolt	Day 0 (=day of inclusion = the only visit of the study)
modification of implicite time parameters	measured with flash electroretinogram and pattern electroretinogram - implicite time in millisecond	Day 0 (=day of inclusion = the only visit of the study)
modification of amplitude of the oscillatory potential	waves P1, P2, P3, P4 measured with flash electroretinogram - amplitude in microvolt	Day 0 (=day of inclusion = the only visit of the study)
modification of implicit time of the oscillatory potential	waves P1, P2, P3, P4 measured with flash electroretinogram - implicite time in millisecond	Day 0 (=day of inclusion = the only visit of the study)
modification of amplitude of the background noise	measured with the flash electroretinogram, flicker 3.0 sequence - amplitude in microvolt	Day 0 (=day of inclusion = the only visit of the study)

Collaborators and Investigators

• Sponsor: Centre Psychothérapique de Nancy
• Investigators: Principal Investigator: Thomas SCHWITZER, Centre Psychothérapique de Nancy

Study record dates

Study Major Dates

• Study Start (Actual): May 13, 2019
• Primary Completion (Actual): March 22, 2021
• Study Completion (Actual): March 22, 2021

Study Registration Dates

• First Submitted: January 10, 2019
• First Submitted That Met QC Criteria: January 25, 2019
• First Posted (Actual): January 28, 2019

Study Record Updates

• Last Update Posted (Actual): December 20, 2021
• Last Update Submitted That Met QC Criteria: December 17, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: retina AND electroretinogram
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Alcoholism
• Other Study ID Numbers: RIPH 2018-02; IDRCB 2018-A02336-49 (Other Identifier: ANSM (French competent authority))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No