Electrophysiological Study of the Functioning of Magnocellular Visual Pathway in Regular Cannabis Users

NCT ID: NCT02864680

Last Updated: 2021-04-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

163 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2019-06-30

Brief Summary

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This study will evaluate the impact of regular use of cannabis on the spatial sensitivity of magnocellular system (visual event-related potential, visual ERP).

Secondary purposes of this study are to evaluate the impact of regular use of cannabis on the temporal sensitivity of magnocellular system (visual event-related potential), on the dynamics of cortical visual processing during face perception test (visual event-related potential) and on functioning of retinal photopic and scotopic systems (electroretinogram).

The ancillary study is a genetic analysis of a group of candidate genes that aims to identify biomarkers for changes in visual processing. This will allow to distinguish among more homogeneous and specific groups in future studies on larger cannabis user population. This ancillary study concerns all participants subject to their informed consent (facultative study).

Detailed Description

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Conditions

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Cannabis Use

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Cannabis users

Group Type OTHER

Electroretinography

Intervention Type OTHER

Contrast sensitivity test during Electroencephalography

Intervention Type OTHER

Stimuli are black and white grids, having different range of spatial frequencies, presented with different contrasts on a grey background thanks to a computer monitor, in a dark room. Participants are requested to maintain central fixation. During the test patients stay sit, head hold by chin strap. A pause can be asked by participant and done at every moment. This test lasts approximately 30 minutes.

Visual simultaneity test during Electroencephalography

Intervention Type OTHER

Two vertical bars are showed on a monitor, on the link and right of point of central fixation. Bars appear simultaneously or with a 10 to 200 ms asynchrony. Participants must determine whether stimuli are simultaneous or asynchronous and answer pressing the link button for simultaneity or right button for asynchrony. During the test patients stay sit, head hold by chin strap. A pause can be asked by participant and done at every moment. This test lasts approximately 30 minutes.

Face perception test during Electroencephalography

Intervention Type OTHER

Faces filtered in different spatial frequence ranges are showed randomly on a monitor, in a dark room. Participants must maintain a central fixation thank to a fixation cross. During the test patients stay sit, head hold by chin strap. A pause can be asked by participant and done at every moment. This test lasts approximately 30 minutes.

CAST (cannabis abuse screening test)

Intervention Type OTHER

Delayed Matching to Sample (DMS) test

Intervention Type OTHER

Spatial Working Memory (SWM) test

Intervention Type OTHER

Rapid Visual Information Processing (RVP) test

Intervention Type OTHER

Test for attentional performance (TAP) / Divided Attention

Intervention Type OTHER

Collection of saliva sample

Intervention Type OTHER

In case of specific consent of participant to ancillary study, for ancillary study

Healthy volunteers, not cannabis/tobacco users

Group Type OTHER

Electroretinography

Intervention Type OTHER

Contrast sensitivity test during Electroencephalography

Intervention Type OTHER

Stimuli are black and white grids, having different range of spatial frequencies, presented with different contrasts on a grey background thanks to a computer monitor, in a dark room. Participants are requested to maintain central fixation. During the test patients stay sit, head hold by chin strap. A pause can be asked by participant and done at every moment. This test lasts approximately 30 minutes.

Visual simultaneity test during Electroencephalography

Intervention Type OTHER

Two vertical bars are showed on a monitor, on the link and right of point of central fixation. Bars appear simultaneously or with a 10 to 200 ms asynchrony. Participants must determine whether stimuli are simultaneous or asynchronous and answer pressing the link button for simultaneity or right button for asynchrony. During the test patients stay sit, head hold by chin strap. A pause can be asked by participant and done at every moment. This test lasts approximately 30 minutes.

Face perception test during Electroencephalography

Intervention Type OTHER

Faces filtered in different spatial frequence ranges are showed randomly on a monitor, in a dark room. Participants must maintain a central fixation thank to a fixation cross. During the test patients stay sit, head hold by chin strap. A pause can be asked by participant and done at every moment. This test lasts approximately 30 minutes.

Delayed Matching to Sample (DMS) test

Intervention Type OTHER

Spatial Working Memory (SWM) test

Intervention Type OTHER

Rapid Visual Information Processing (RVP) test

Intervention Type OTHER

Test for attentional performance (TAP) / Divided Attention

Intervention Type OTHER

Collection of saliva sample

Intervention Type OTHER

In case of specific consent of participant to ancillary study, for ancillary study

Healthy volunteers, tobacco users

Group Type OTHER

Electroretinography

Intervention Type OTHER

Contrast sensitivity test during Electroencephalography

Intervention Type OTHER

Stimuli are black and white grids, having different range of spatial frequencies, presented with different contrasts on a grey background thanks to a computer monitor, in a dark room. Participants are requested to maintain central fixation. During the test patients stay sit, head hold by chin strap. A pause can be asked by participant and done at every moment. This test lasts approximately 30 minutes.

Visual simultaneity test during Electroencephalography

Intervention Type OTHER

Two vertical bars are showed on a monitor, on the link and right of point of central fixation. Bars appear simultaneously or with a 10 to 200 ms asynchrony. Participants must determine whether stimuli are simultaneous or asynchronous and answer pressing the link button for simultaneity or right button for asynchrony. During the test patients stay sit, head hold by chin strap. A pause can be asked by participant and done at every moment. This test lasts approximately 30 minutes.

Face perception test during Electroencephalography

Intervention Type OTHER

Faces filtered in different spatial frequence ranges are showed randomly on a monitor, in a dark room. Participants must maintain a central fixation thank to a fixation cross. During the test patients stay sit, head hold by chin strap. A pause can be asked by participant and done at every moment. This test lasts approximately 30 minutes.

Delayed Matching to Sample (DMS) test

Intervention Type OTHER

Spatial Working Memory (SWM) test

Intervention Type OTHER

Rapid Visual Information Processing (RVP) test

Intervention Type OTHER

Test for attentional performance (TAP) / Divided Attention

Intervention Type OTHER

Collection of saliva sample

Intervention Type OTHER

In case of specific consent of participant to ancillary study, for ancillary study

Schizophrenia patients

Group Type OTHER

Electroretinography

Intervention Type OTHER

Contrast sensitivity test during Electroencephalography

Intervention Type OTHER

Stimuli are black and white grids, having different range of spatial frequencies, presented with different contrasts on a grey background thanks to a computer monitor, in a dark room. Participants are requested to maintain central fixation. During the test patients stay sit, head hold by chin strap. A pause can be asked by participant and done at every moment. This test lasts approximately 30 minutes.

Visual simultaneity test during Electroencephalography

Intervention Type OTHER

Two vertical bars are showed on a monitor, on the link and right of point of central fixation. Bars appear simultaneously or with a 10 to 200 ms asynchrony. Participants must determine whether stimuli are simultaneous or asynchronous and answer pressing the link button for simultaneity or right button for asynchrony. During the test patients stay sit, head hold by chin strap. A pause can be asked by participant and done at every moment. This test lasts approximately 30 minutes.

Face perception test during Electroencephalography

Intervention Type OTHER

Faces filtered in different spatial frequence ranges are showed randomly on a monitor, in a dark room. Participants must maintain a central fixation thank to a fixation cross. During the test patients stay sit, head hold by chin strap. A pause can be asked by participant and done at every moment. This test lasts approximately 30 minutes.

CAST (cannabis abuse screening test)

Intervention Type OTHER

PANSS (Positive And Negative Symptoms Scale) test

Intervention Type OTHER

Delayed Matching to Sample (DMS) test

Intervention Type OTHER

Spatial Working Memory (SWM) test

Intervention Type OTHER

Rapid Visual Information Processing (RVP) test

Intervention Type OTHER

Test for attentional performance (TAP) / Divided Attention

Intervention Type OTHER

Collection of saliva sample

Intervention Type OTHER

In case of specific consent of participant to ancillary study, for ancillary study

Interventions

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Electroretinography

Intervention Type OTHER

Contrast sensitivity test during Electroencephalography

Stimuli are black and white grids, having different range of spatial frequencies, presented with different contrasts on a grey background thanks to a computer monitor, in a dark room. Participants are requested to maintain central fixation. During the test patients stay sit, head hold by chin strap. A pause can be asked by participant and done at every moment. This test lasts approximately 30 minutes.

Intervention Type OTHER

Visual simultaneity test during Electroencephalography

Two vertical bars are showed on a monitor, on the link and right of point of central fixation. Bars appear simultaneously or with a 10 to 200 ms asynchrony. Participants must determine whether stimuli are simultaneous or asynchronous and answer pressing the link button for simultaneity or right button for asynchrony. During the test patients stay sit, head hold by chin strap. A pause can be asked by participant and done at every moment. This test lasts approximately 30 minutes.

Intervention Type OTHER

Face perception test during Electroencephalography

Faces filtered in different spatial frequence ranges are showed randomly on a monitor, in a dark room. Participants must maintain a central fixation thank to a fixation cross. During the test patients stay sit, head hold by chin strap. A pause can be asked by participant and done at every moment. This test lasts approximately 30 minutes.

Intervention Type OTHER

CAST (cannabis abuse screening test)

Intervention Type OTHER

PANSS (Positive And Negative Symptoms Scale) test

Intervention Type OTHER

Delayed Matching to Sample (DMS) test

Intervention Type OTHER

Spatial Working Memory (SWM) test

Intervention Type OTHER

Rapid Visual Information Processing (RVP) test

Intervention Type OTHER

Test for attentional performance (TAP) / Divided Attention

Intervention Type OTHER

Collection of saliva sample

In case of specific consent of participant to ancillary study, for ancillary study

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Affiliation to social security plan
* Normal visual acuity or adjusted to normal and normal dilated fundus examination
* Signature of informed consent
* Cannabis user group: More than 7 cannabis uses per week during the previous month
* Cannabis user group: Positive urinary analysis for presence of cannabis
* Healthy, non user control group: Absence of cannabis and tobacco use during last 12 months
* Healthy, non user control group: Negative urinary analysis for presence of cannabis
* Healthy, non user control group: Age and sex matching with cannabis user group
* Healthy, tobacco user control group: Tobacco use from at least 12 months
* Healthy, tobacco user control group: Low to very strong addiction to tobacco (Fagerström test)
* Healthy, tobacco user control group: Absence of cannabis use from more than 12 months
* Healthy, tobacco user control group: Negative urinary analysis for presence of cannabis
* Healthy, tobacco user control group:Age and sex matching with cannabis user group
* Schizophrenia patient control group: Schizophrenia according to DMS IV criteria (MINI test)
* Schizophrenia patient control group: Absence of cannabis use from more than one month (regardless of tobacco use)
* Schizophrenia patient control group: Negative urinary analysis for presence of cannabis
* Schizophrenia patient control group: Age and sex matching with cannabis user group

Exclusion Criteria

* Acute psychiatric pathology (axis I of DSM IV, measured by MINI) except anxiety disorder (except schizophrenia group)
* Deficiency of the subject making difficult or impossible his/her participation to the study or the comprehension of the information
* Dyslexia
* Addiction to alcohol according to AUDIT scale
* Abuse or addiction to other substances according to DSM IV criteria
* Acute retinal disorder
* Chronic glaucoma
* Ophthalmic pathology affecting visual acuity
* Current ocular infection
* Persons under guardianship, curatorship or judicial protection
* Pregnant or breast-feeding women
* Persons with life-and-death emergency
* Absence of social security plan
* Results of preliminary medical examinations incompatible with the study
* Simultaneous participation to another therapeutic interventional study
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Central Hospital, Nancy, France

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Vincent LAPREVOTE

Role: PRINCIPAL_INVESTIGATOR

Maison des Addictions - CHU de Nancy, France

Locations

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Maison des Addictions - CHU de Nancy, Hôpital St Julien

Nancy, , France

Site Status

Countries

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France

References

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Remy I, Bernardin F, Ligier F, Krieg J, Maillard L, Schwan R, Schwitzer T, Laprevote V. Association between retinal and cortical visual electrophysiological impairments in schizophrenia. J Psychiatry Neurosci. 2023 May 19;48(3):E171-E178. doi: 10.1503/jpn.220224. Print 2023 May-Jun.

Reference Type DERIVED
PMID: 37208126 (View on PubMed)

Bernardin F, Schwitzer T, Schwan R, Angioi-Duprez K, Ligier F, Bourion-Bedes S, Jansen C, Giersch A, Laprevote V. Altered central vision and amacrine cells dysfunction as marker of hypodopaminergic activity in treated patients with schizophrenia. Schizophr Res. 2022 Jan;239:134-141. doi: 10.1016/j.schres.2021.11.049. Epub 2021 Dec 7.

Reference Type DERIVED
PMID: 34891077 (View on PubMed)

Remy I, Schwitzer T, Albuisson E, Schwan R, Krieg J, Bernardin F, Ligier F, Lalanne L, Maillard L, Laprevote V. Impaired P100 among regular cannabis users in response to magnocellular biased visual stimuli. Prog Neuropsychopharmacol Biol Psychiatry. 2022 Mar 8;113:110437. doi: 10.1016/j.pnpbp.2021.110437. Epub 2021 Sep 11.

Reference Type DERIVED
PMID: 34520807 (View on PubMed)

Other Identifiers

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2013-A00097-38

Identifier Type: -

Identifier Source: org_study_id

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