NCT02864680

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
163

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

August 3, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 12, 2016

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

April 29, 2021

Status Verified

June 1, 2019

Enrollment Period

5.3 years

First QC Date

August 3, 2016

Last Update Submit

April 27, 2021

Conditions

Keywords

cannabismagnocellular pathway

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

OTHER
Other: ElectroretinographyOther: Contrast sensitivity test during ElectroencephalographyOther: Visual simultaneity test during ElectroencephalographyOther: Face perception test during ElectroencephalographyOther: CAST (cannabis abuse screening test)Other: Delayed Matching to Sample (DMS) testOther: Spatial Working Memory (SWM) testOther: Rapid Visual Information Processing (RVP) testOther: Test for attentional performance (TAP) / Divided AttentionOther: Collection of saliva sample

Healthy volunteers, not cannabis/tobacco users

OTHER
Other: ElectroretinographyOther: Contrast sensitivity test during ElectroencephalographyOther: Visual simultaneity test during ElectroencephalographyOther: Face perception test during ElectroencephalographyOther: Delayed Matching to Sample (DMS) testOther: Spatial Working Memory (SWM) testOther: Rapid Visual Information Processing (RVP) testOther: Test for attentional performance (TAP) / Divided AttentionOther: Collection of saliva sample

Healthy volunteers, tobacco users

OTHER
Other: ElectroretinographyOther: Contrast sensitivity test during ElectroencephalographyOther: Visual simultaneity test during ElectroencephalographyOther: Face perception test during ElectroencephalographyOther: Delayed Matching to Sample (DMS) testOther: Spatial Working Memory (SWM) testOther: Rapid Visual Information Processing (RVP) testOther: Test for attentional performance (TAP) / Divided AttentionOther: Collection of saliva sample

Schizophrenia patients

OTHER
Other: ElectroretinographyOther: Contrast sensitivity test during ElectroencephalographyOther: Visual simultaneity test during ElectroencephalographyOther: Face perception test during ElectroencephalographyOther: CAST (cannabis abuse screening test)Other: PANSS (Positive And Negative Symptoms Scale) testOther: Delayed Matching to Sample (DMS) testOther: Spatial Working Memory (SWM) testOther: Rapid Visual Information Processing (RVP) testOther: Test for attentional performance (TAP) / Divided AttentionOther: Collection of saliva sample

Interventions

Cannabis usersHealthy volunteers, not cannabis/tobacco usersHealthy volunteers, tobacco usersSchizophrenia patients

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.

Cannabis usersHealthy volunteers, not cannabis/tobacco usersHealthy volunteers, tobacco usersSchizophrenia patients

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.

Cannabis usersHealthy volunteers, not cannabis/tobacco usersHealthy volunteers, tobacco usersSchizophrenia patients

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.

Cannabis usersHealthy volunteers, not cannabis/tobacco usersHealthy volunteers, tobacco usersSchizophrenia patients
Cannabis usersSchizophrenia patients
Cannabis usersHealthy volunteers, not cannabis/tobacco usersHealthy volunteers, tobacco usersSchizophrenia patients
Cannabis usersHealthy volunteers, not cannabis/tobacco usersHealthy volunteers, tobacco usersSchizophrenia patients
Cannabis usersHealthy volunteers, not cannabis/tobacco usersHealthy volunteers, tobacco usersSchizophrenia patients
Cannabis usersHealthy volunteers, not cannabis/tobacco usersHealthy volunteers, tobacco usersSchizophrenia patients

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

Cannabis usersHealthy volunteers, not cannabis/tobacco usersHealthy volunteers, tobacco usersSchizophrenia patients

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

Location

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.

  • 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.

  • 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.

MeSH Terms

Conditions

Marijuana Abuse

Interventions

Gene ExpressionSuccimer

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Genetic PhenomenaSuccinatesDicarboxylic AcidsAcids, AcyclicCarboxylic AcidsOrganic ChemicalsSulfhydryl CompoundsSulfur Compounds

Study Officials

  • Vincent LAPREVOTE

    Maison des Addictions - CHU de Nancy, France

    PRINCIPAL INVESTIGATOR

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

Locations