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Cerebellar Alterations in Individuals With a Cannabis Use Disorder

Primary Purpose

Cannabis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Visuo-motor rotation
Explicit strategy
Sponsored by
Universitat Pompeu Fabra
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Cannabis focused on measuring Learning, Cerebellum

Eligibility Criteria

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

Inclusion Criteria:

  • Patients diagnosed with a Cannabis use disorder following Diagnostic and Statistical Manual (DSM-V) criteria.
  • Patients screen positive to cannabis in the urine analysis performed a week prior to assessment.
  • Right-handed patients.
  • Patients provide a signed consent.

Exclusion Criteria:

  • Patients with another current substance use disorder (with the exception of tobacco).
  • Patients with a visual impairment that has not been corrected.
  • Patients with a cognitive impairment such as mental retardation.
  • Patients with psychotic disorders.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Active Comparator

    Experimental

    Active Comparator

    Arm Label

    Experimental Explicit

    Control Explicit

    Experimental Implicit

    Control Implicit

    Arm Description

    Cannabis user performs visuo-motor rotation tasks informed of an explicit strategy to maximise performance

    Healthy subject performs visuo-motor rotation tasks informed of an explicit strategy to maximise performance

    Cannabis user performs visuo-motor rotation tasks without being informed of the explicit strategy

    Healthy subject performs visuo-motor rotation tasks without being informed of the explicit strategy

    Outcomes

    Primary Outcome Measures

    Directional error of hand trajectories towards a target

    Secondary Outcome Measures

    Reaction times
    Intrinsic Motivational Inventory

    Full Information

    First Posted
    June 6, 2016
    Last Updated
    November 1, 2018
    Sponsor
    Universitat Pompeu Fabra
    Collaborators
    Hospital Clinic of Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02816034
    Brief Title
    Cerebellar Alterations in Individuals With a Cannabis Use Disorder
    Official Title
    Alterations in Cerebellar-dependent Adaptation Due to Cannabis Use Measured With an Explicit-implicit Visuo-motor Learning Paradigm
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2016 (Actual)
    Primary Completion Date
    April 2017 (Actual)
    Study Completion Date
    April 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Universitat Pompeu Fabra
    Collaborators
    Hospital Clinic of Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to investigate if individuals with a cannabis use disorder have an impaired cerebellar function by assessing possible alterations to their implicit adaptation during a visuomotor rotation task.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cannabis
    Keywords
    Learning, Cerebellum

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    32 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Experimental Explicit
    Arm Type
    Experimental
    Arm Description
    Cannabis user performs visuo-motor rotation tasks informed of an explicit strategy to maximise performance
    Arm Title
    Control Explicit
    Arm Type
    Active Comparator
    Arm Description
    Healthy subject performs visuo-motor rotation tasks informed of an explicit strategy to maximise performance
    Arm Title
    Experimental Implicit
    Arm Type
    Experimental
    Arm Description
    Cannabis user performs visuo-motor rotation tasks without being informed of the explicit strategy
    Arm Title
    Control Implicit
    Arm Type
    Active Comparator
    Arm Description
    Healthy subject performs visuo-motor rotation tasks without being informed of the explicit strategy
    Intervention Type
    Behavioral
    Intervention Name(s)
    Visuo-motor rotation
    Intervention Description
    Participant moves a cursor on a screen by sliding a pen over a digital tablet. Participants perform a center-out movement, aiming to a target that appears over one of a set of eight markers radially distributed. In several block of trials, the mapping of the pen position to the cursor is rotated.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Explicit strategy
    Intervention Description
    Participant is provided with an explicit instruction as to how counteract the effects of the visuo-motor rotation via aiming to a marker adjacent target
    Primary Outcome Measure Information:
    Title
    Directional error of hand trajectories towards a target
    Time Frame
    1 day (a single session)
    Secondary Outcome Measure Information:
    Title
    Reaction times
    Time Frame
    1 day (a single session)
    Title
    Intrinsic Motivational Inventory
    Time Frame
    1 day (a single session)

    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: Patients diagnosed with a Cannabis use disorder following Diagnostic and Statistical Manual (DSM-V) criteria. Patients screen positive to cannabis in the urine analysis performed a week prior to assessment. Right-handed patients. Patients provide a signed consent. Exclusion Criteria: Patients with another current substance use disorder (with the exception of tobacco). Patients with a visual impairment that has not been corrected. Patients with a cognitive impairment such as mental retardation. Patients with psychotic disorders.

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    20697860
    Citation
    Taylor JA, Klemfuss NM, Ivry RB. An explicit strategy prevails when the cerebellum fails to compute movement errors. Cerebellum. 2010 Dec;9(4):580-6. doi: 10.1007/s12311-010-0201-x.
    Results Reference
    background
    PubMed Identifier
    16597717
    Citation
    Mazzoni P, Krakauer JW. An implicit plan overrides an explicit strategy during visuomotor adaptation. J Neurosci. 2006 Apr 5;26(14):3642-5. doi: 10.1523/JNEUROSCI.5317-05.2006.
    Results Reference
    background

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    Cerebellar Alterations in Individuals With a Cannabis Use Disorder

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