Electrophysiological Study of the Functioning of Magnocellular Visual Pathway in Regular Cannabis Users
CAUSA MAP
1 other identifier
interventional
163
1 country
1
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2014
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2014
CompletedFirst Submitted
Initial submission to the registry
August 3, 2016
CompletedFirst Posted
Study publicly available on registry
August 12, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2019
CompletedApril 29, 2021
June 1, 2019
5.3 years
August 3, 2016
April 27, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Amplitude of P100 wave in contrast sensibility test
up to 1 month
Culmination time of the P100 wave in contrast sensibility test
up to 1 month
Secondary Outcomes (10)
Amplitude of P100 wave in visual simultaneity test
up to 1 month
Culmination time of P100 wave in visual simultaneity test
up to 1 month
Amplitude of P100 wave in face perception test
up to 1 month
Amplitude of N170 wave in face perception test
up to 1 month
Culmination time of P100 wave in face perception test
up to 1 month
- +5 more secondary outcomes
Other Outcomes (1)
Relationship between variants of candidate genes for alterations of visual treatment and amplitude of P100 wave in contrast sensibility test
up to 3 years
Study Arms (4)
Cannabis users
OTHERHealthy volunteers, not cannabis/tobacco users
OTHERHealthy volunteers, tobacco users
OTHERSchizophrenia patients
OTHERInterventions
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.
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.
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.
In case of specific consent of participant to ancillary study, for ancillary study
Eligibility Criteria
You may qualify if:
- 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)
- +2 more criteria
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Maison des Addictions - CHU de Nancy, Hôpital St Julien
Nancy, France
Related Publications (3)
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.
PMID: 37208126DERIVEDBernardin 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.
PMID: 34891077DERIVEDRemy 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.
PMID: 34520807DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Vincent LAPREVOTE
Maison des Addictions - CHU de Nancy, France
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 3, 2016
First Posted
August 12, 2016
Study Start
February 1, 2014
Primary Completion
June 1, 2019
Study Completion
June 1, 2019
Last Updated
April 29, 2021
Record last verified: 2019-06
Data Sharing
- IPD Sharing
- Will not share