Alcohol Use DisorderERICANCT03818971
Study of Retinal Function Using Electroretinogram in Regular Alcohol Users
A study testing electroretinogram (flash, pattern and multifocal) in people with Alcohol Use Disorder, run by Centre Psychothérapique de Nancy at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Use Disorder
- What is being tested?
- electroretinogram (flash, pattern and multifocal)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 13 May 2019to 22 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- aged between 18 and 35 years
- alcohol use disorder according to the DSM 5
- affiliation to a social security scheme
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Alcohol Use Disorder
- Being tested
- electroretinogram (flash, pattern and multifocal)
- Keywords
- retina AND electroretinogram
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| alcohol consumption with alcohol use disorder (AUD) | Experimental | 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 Receives: Other: electroretinogram (flash, pattern and multifocal) |
| alcohol consumption without alcohol use disorder | Other | 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 Receives: Other: electroretinogram (flash, pattern and multifocal) |
| no alcohol consumption | Other | 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 Receives: Other: electroretinogram (flash, pattern and multifocal) |
What is being measured
The primary outcome is the main question the study is designed to answer.
modification of amplitude
measured with flash electroretinogram and pattern electroretinogram / amplitude in microvolt
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Day 0 (=day of inclusion = the only visit of the study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2019
- Study start13 May 2019
- Primary completion22 Mar 2021
- Study completion22 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- mono centric study, in parallel groups, controlled, non-randomized and open
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Psychothérapique de Nancy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas SCHWITZER, Principal investigator, Centre Psychothérapique de Nancy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03818971
- Sponsor's protocol ID
- RIPH 2018-02
- Other IDs
- IDRCB 2018-A02336-49
- Acronym
- ERICA
- Status last verified
- Oct 2021
- First submitted
- 10 Jan 2019
- Last updated
- 20 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Retinal Function Using Electroretinogram in Regular Alcohol Users
- ClinicalTrials.gov ID
- NCT03818971
- Acronym / sponsor ID
- ERICA / RIPH 2018-02
- Conditions
- Alcohol Use Disorder
- Keywords
- retina AND electroretinogram
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Centre Psychothérapique de NancyUniversity, hospital or other
- Study start
- 13 May 2019 (actual)
- Primary completion
- 22 Mar 2021 (actual)
- Study completion
- 22 Mar 2021 (actual)
- First posted
- 28 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- mono centric study, in parallel groups, controlled, non-randomized and open
| Arm | Type | Receives |
|---|---|---|
| alcohol consumption with alcohol use disorder (AUD) | Experimental | Other: electroretinogram (flash, pattern and multifocal)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 |
| alcohol consumption without alcohol use disorder | Other | Other: electroretinogram (flash, pattern and multifocal)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 |
| no alcohol consumption | Other | Other: electroretinogram (flash, pattern and multifocal)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 |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- aged between 18 and 35 years
- alcohol use disorder according to the DSM 5
- affiliation to a social security scheme
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 with alcohol use disorder (AUD), alcohol consumption without alcohol use disorder, no alcohol consumption |
Primary outcome
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas SCHWITZER principal investigator
Centre Psychothérapique de Nancy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing electroretinogram (flash, pattern and multifocal) in people with Alcohol Use Disorder, run by Centre Psychothérapique de Nancy at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
modification of amplitude (time frame: Day 0 (=day of inclusion = the only visit of the study)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2021.