CompletedNot Applicable

Study of Retinal Function Using Electroretinogram in Regular Alcohol Users

France60 participantsStarted 2019-05-13

Plain-language 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.

Who can participate

Age range

18 Years – 35 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

modification of amplitude

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

modification of implicite time parameters

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

modification of amplitude of the oscillatory potential

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

modification of implicit time of the oscillatory potential

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

modification of amplitude of the background noise

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

Trial details

NCT IDNCT03818971

SponsorCentre Psychothérapique de Nancy

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-03-22

View on ClinicalTrials.gov More Alcohol Use Disorder trials

Plain-language summary

Who can participate

Age range

18 Years – 35 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

modification of amplitude

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

modification of implicite time parameters

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

modification of amplitude of the oscillatory potential

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

modification of implicit time of the oscillatory potential

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

modification of amplitude of the background noise

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