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Effects of Chronic Intake of Cannabis on Contrast Sensitivity

Primary Purpose

Cannabis Dependence

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
electroretinogram
contrast sensitivity tests
Sponsored by
University Hospital, Strasbourg, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Cannabis Dependence

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

"Cannabis" Arm

  • patient addicted to cannabis
  • Positive CAST test result
  • Urine tested positive for cannabis metabolites

"Tobacco" Arm

  • positive Fagerström test result
  • No cannabis intake in the last year before inclusion
  • No previous history of cannabis use

"Healthy Volunteers"

  • No tobacco or cannabis intake in the last year before inclusion
  • No history of addictive disorders

Exclusion Criteria:

  • addiction to other substances than cannabis or tobacco
  • benzodiazepine treatment
  • patient with history of benzodiazepine treatment
  • patient with history of general anesthesia in the last 3 months before inclusion
  • patient with history of head trauma
  • Pregnant woman
  • breast feeding woman
  • Adults under supervision or guardianship

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Other

    Other

    Other

    Arm Label

    "Cannabis" Arm

    "Tobacco" Arm

    "Healthy volunteers"

    Arm Description

    patient addicted to cannabis

    patient addicted to tobacco

    no smokers

    Outcomes

    Primary Outcome Measures

    The contrast detection treshold
    Comparison of the contrast detection threshold of the 3 groups

    Secondary Outcome Measures

    Full Information

    First Posted
    February 12, 2013
    Last Updated
    July 10, 2019
    Sponsor
    University Hospital, Strasbourg, France
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01793961
    Brief Title
    Effects of Chronic Intake of Cannabis on Contrast Sensitivity
    Official Title
    Effects of Chronic Intake of Cannabis on Contrast Sensitivity
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    March 22, 2013 (Actual)
    Primary Completion Date
    November 30, 2015 (Actual)
    Study Completion Date
    September 10, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University Hospital, Strasbourg, France

    4. Oversight

    5. Study Description

    Brief Summary
    Rates of driving under the influence of cannabis have risen in recent years. Cannabis is involved in 1/3 of motor vehicle collisions. The chronic use of cannabis is known to affect dopaminergic regulation and may thus impair contrast sensitivity. In turn, contrast sensitivity disorders could originate difficulties to anticipate and avoid collision with objects, especially when objects are in movement. The investigators goal is to examine the effects of a chronic intake of cannabis on contrast sensitivity. The observed values will be compared to standard references. In addition, since smoking cannabis is always associated with tobacco, the investigators will control the effects of tobacco on contrast sensitivity. In this study, the investigators will include 36 cannabis addicts, 36 tobacco addicts and 36 no smokers. The investigators will present gratings with different spatial frequencies and the investigators will determine contrast thresholds for static and dynamic (moving) gratings. The investigators predict that cannabis addicts will present abnormal contrast sensitivity especially in case of dynamic presentation of gradings.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cannabis Dependence

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    "Cannabis" Arm
    Arm Type
    Other
    Arm Description
    patient addicted to cannabis
    Arm Title
    "Tobacco" Arm
    Arm Type
    Other
    Arm Description
    patient addicted to tobacco
    Arm Title
    "Healthy volunteers"
    Arm Type
    Other
    Arm Description
    no smokers
    Intervention Type
    Other
    Intervention Name(s)
    electroretinogram
    Intervention Type
    Other
    Intervention Name(s)
    contrast sensitivity tests
    Primary Outcome Measure Information:
    Title
    The contrast detection treshold
    Description
    Comparison of the contrast detection threshold of the 3 groups
    Time Frame
    up to 9 days after inclusion

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: "Cannabis" Arm patient addicted to cannabis Positive CAST test result Urine tested positive for cannabis metabolites "Tobacco" Arm positive Fagerström test result No cannabis intake in the last year before inclusion No previous history of cannabis use "Healthy Volunteers" No tobacco or cannabis intake in the last year before inclusion No history of addictive disorders Exclusion Criteria: addiction to other substances than cannabis or tobacco benzodiazepine treatment patient with history of benzodiazepine treatment patient with history of general anesthesia in the last 3 months before inclusion patient with history of head trauma Pregnant woman breast feeding woman Adults under supervision or guardianship

    12. IPD Sharing Statement

    Learn more about this trial

    Effects of Chronic Intake of Cannabis on Contrast Sensitivity

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