NCT02816034

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2016

Shorter than P25 for not_applicable

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

June 1, 2016

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

June 6, 2016

Completed
22 days until next milestone

First Posted

Study publicly available on registry

June 28, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

November 5, 2018

Status Verified

November 1, 2018

Enrollment Period

10 months

First QC Date

June 6, 2016

Last Update Submit

November 1, 2018

Conditions

Cannabis

Keywords

LearningCerebellum

Outcome Measures

Primary Outcomes (1)

  • Directional error of hand trajectories towards a target

    1 day (a single session)

Secondary Outcomes (2)

  • Reaction times

    1 day (a single session)

  • Intrinsic Motivational Inventory

    1 day (a single session)

Study Arms (4)

Experimental Explicit

EXPERIMENTAL

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

Behavioral: Visuo-motor rotationBehavioral: Explicit strategy

Control Explicit

ACTIVE COMPARATOR

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

Behavioral: Visuo-motor rotation

Experimental Implicit

EXPERIMENTAL

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

Behavioral: Visuo-motor rotationBehavioral: Explicit strategy

Control Implicit

ACTIVE COMPARATOR

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

Behavioral: Visuo-motor rotation

Interventions

Visuo-motor rotationBEHAVIORAL

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.

Control ExplicitControl ImplicitExperimental ExplicitExperimental Implicit
Explicit strategyBEHAVIORAL

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

Experimental ExplicitExperimental Implicit

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 20697860BACKGROUND

  • 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.

    PMID: 16597717BACKGROUND

MeSH Terms

Conditions

Marijuana Abuse

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 6, 2016

First Posted

June 28, 2016

Study Start

June 1, 2016

Primary Completion

April 1, 2017

Study Completion

April 1, 2017

Last Updated

November 5, 2018

Record last verified: 2018-11