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

Primary Purpose

Alcohol Use Disorder

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
electroretinogram (flash, pattern and multifocal)
Sponsored by
Centre Psychothérapique de Nancy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Alcohol Use Disorder focused on measuring retina AND electroretinogram

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Centre Psychothérapique de Nancy

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Other

Other

Arm Label

alcohol consumption with alcohol use disorder (AUD)

alcohol consumption without alcohol use disorder

no alcohol consumption

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

modification of amplitude
measured with flash electroretinogram and pattern electroretinogram / amplitude in microvolt
modification of implicite time parameters
measured with flash electroretinogram and pattern electroretinogram - implicite time in millisecond
modification of amplitude of the oscillatory potential
waves P1, P2, P3, P4 measured with flash electroretinogram - amplitude in microvolt
modification of implicit time of the oscillatory potential
waves P1, P2, P3, P4 measured with flash electroretinogram - implicite time in millisecond
modification of amplitude of the background noise
measured with the flash electroretinogram, flicker 3.0 sequence - amplitude in microvolt

Secondary Outcome Measures

Full Information

First Posted
January 10, 2019
Last Updated
December 17, 2021
Sponsor
Centre Psychothérapique de Nancy
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1. Study Identification

Unique Protocol Identification Number
NCT03818971
Brief Title
Study of Retinal Function Using Electroretinogram in Regular Alcohol Users
Acronym
ERICA
Official Title
Study of Retinal Function Using Electroretinogram in Regular Alcohol Users
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
May 13, 2019 (Actual)
Primary Completion Date
March 22, 2021 (Actual)
Study Completion Date
March 22, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Psychothérapique de Nancy

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use Disorder
Keywords
retina AND electroretinogram

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
mono centric study, in parallel groups, controlled, non-randomized and open
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
alcohol consumption with alcohol use disorder (AUD)
Arm Type
Experimental
Arm Description
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
Arm Title
alcohol consumption without alcohol use disorder
Arm Type
Other
Arm Description
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
Arm Title
no alcohol consumption
Arm Type
Other
Arm Description
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
Intervention Type
Other
Intervention Name(s)
electroretinogram (flash, pattern and multifocal)
Intervention Description
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 Outcome Measure Information:
Title
modification of amplitude
Description
measured with flash electroretinogram and pattern electroretinogram / amplitude in microvolt
Time Frame
Day 0 (=day of inclusion = the only visit of the study)
Title
modification of implicite time parameters
Description
measured with flash electroretinogram and pattern electroretinogram - implicite time in millisecond
Time Frame
Day 0 (=day of inclusion = the only visit of the study)
Title
modification of amplitude of the oscillatory potential
Description
waves P1, P2, P3, P4 measured with flash electroretinogram - amplitude in microvolt
Time Frame
Day 0 (=day of inclusion = the only visit of the study)
Title
modification of implicit time of the oscillatory potential
Description
waves P1, P2, P3, P4 measured with flash electroretinogram - implicite time in millisecond
Time Frame
Day 0 (=day of inclusion = the only visit of the study)
Title
modification of amplitude of the background noise
Description
measured with the flash electroretinogram, flicker 3.0 sequence - amplitude in microvolt
Time Frame
Day 0 (=day of inclusion = the only visit of the study)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas SCHWITZER
Organizational Affiliation
Centre Psychothérapique de Nancy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Psychothérapique de Nancy
City
Laxou
State/Province
Nancy
ZIP/Postal Code
54520
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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Study of Retinal Function Using Electroretinogram in Regular Alcohol Users

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