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Electrophysiological Study of the Functioning of Magnocellular Visual Pathway in Regular Cannabis Users (CAUSA MAP)

Primary Purpose

Cannabis Use

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Electroretinography
Contrast sensitivity test during Electroencephalography
Visual simultaneity test during Electroencephalography
Face perception test during Electroencephalography
CAST (cannabis abuse screening test)
PANSS (Positive And Negative Symptoms Scale) test
Delayed Matching to Sample (DMS) test
Spatial Working Memory (SWM) test
Rapid Visual Information Processing (RVP) test
Test for attentional performance (TAP) / Divided Attention
Collection of saliva sample
Sponsored by
Central Hospital, Nancy, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Cannabis Use focused on measuring cannabis, magnocellular pathway

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Maison des Addictions - CHU de Nancy, Hôpital St Julien

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Other

Other

Other

Arm Label

Cannabis users

Healthy volunteers, not cannabis/tobacco users

Healthy volunteers, tobacco users

Schizophrenia patients

Arm Description

Outcomes

Primary Outcome Measures

Amplitude of P100 wave in contrast sensibility test
Culmination time of the P100 wave in contrast sensibility test

Secondary Outcome Measures

Amplitude of P100 wave in visual simultaneity test
Culmination time of P100 wave in visual simultaneity test
Amplitude of P100 wave in face perception test
Amplitude of N170 wave in face perception test
Culmination time of P100 wave in face perception test
Culmination time of N170 wave in face perception test
Amplitude of "a" wave in different ERG sequences
Amplitude of "b" wave in different ERG sequences
Culmination time of "a" wave in different ERG sequences
Culmination time of "b" wave in different ERG sequences

Full Information

First Posted
August 3, 2016
Last Updated
April 27, 2021
Sponsor
Central Hospital, Nancy, France
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1. Study Identification

Unique Protocol Identification Number
NCT02864680
Brief Title
Electrophysiological Study of the Functioning of Magnocellular Visual Pathway in Regular Cannabis Users
Acronym
CAUSA MAP
Official Title
Electrophysiological Study of the Functioning of Magnocellular Visual Pathway in Regular Cannabis Users
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
February 2014 (Actual)
Primary Completion Date
June 2019 (Actual)
Study Completion Date
June 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Central Hospital, Nancy, France

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cannabis Use
Keywords
cannabis, magnocellular pathway

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
163 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cannabis users
Arm Type
Other
Arm Title
Healthy volunteers, not cannabis/tobacco users
Arm Type
Other
Arm Title
Healthy volunteers, tobacco users
Arm Type
Other
Arm Title
Schizophrenia patients
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Electroretinography
Intervention Type
Other
Intervention Name(s)
Contrast sensitivity test during Electroencephalography
Intervention Description
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
Intervention Name(s)
Visual simultaneity test during Electroencephalography
Intervention Description
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
Intervention Name(s)
Face perception test during Electroencephalography
Intervention Description
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
Intervention Name(s)
CAST (cannabis abuse screening test)
Intervention Type
Other
Intervention Name(s)
PANSS (Positive And Negative Symptoms Scale) test
Intervention Type
Other
Intervention Name(s)
Delayed Matching to Sample (DMS) test
Intervention Type
Other
Intervention Name(s)
Spatial Working Memory (SWM) test
Intervention Type
Other
Intervention Name(s)
Rapid Visual Information Processing (RVP) test
Intervention Type
Other
Intervention Name(s)
Test for attentional performance (TAP) / Divided Attention
Intervention Type
Other
Intervention Name(s)
Collection of saliva sample
Intervention Description
In case of specific consent of participant to ancillary study, for ancillary study
Primary Outcome Measure Information:
Title
Amplitude of P100 wave in contrast sensibility test
Time Frame
up to 1 month
Title
Culmination time of the P100 wave in contrast sensibility test
Time Frame
up to 1 month
Secondary Outcome Measure Information:
Title
Amplitude of P100 wave in visual simultaneity test
Time Frame
up to 1 month
Title
Culmination time of P100 wave in visual simultaneity test
Time Frame
up to 1 month
Title
Amplitude of P100 wave in face perception test
Time Frame
up to 1 month
Title
Amplitude of N170 wave in face perception test
Time Frame
up to 1 month
Title
Culmination time of P100 wave in face perception test
Time Frame
up to 1 month
Title
Culmination time of N170 wave in face perception test
Time Frame
up to 1 month
Title
Amplitude of "a" wave in different ERG sequences
Time Frame
day 0
Title
Amplitude of "b" wave in different ERG sequences
Time Frame
day 0
Title
Culmination time of "a" wave in different ERG sequences
Time Frame
day 0
Title
Culmination time of "b" wave in different ERG sequences
Time Frame
day 0
Other Pre-specified Outcome Measures:
Title
Relationship between variants of candidate genes for alterations of visual treatment and amplitude of P100 wave in contrast sensibility test
Time Frame
up to 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vincent LAPREVOTE
Organizational Affiliation
Maison des Addictions - CHU de Nancy, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maison des Addictions - CHU de Nancy, Hôpital St Julien
City
Nancy
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34891077
Citation
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.
Results Reference
derived
PubMed Identifier
34520807
Citation
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.
Results Reference
derived

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

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