CannabisNCT02816034
Cerebellar Alterations in Individuals With a Cannabis Use Disorder
A study testing Visuo-motor rotation and Explicit strategy in people with Cannabis, run by Universitat Pompeu Fabra.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Cannabis
- What is being tested?
- Visuo-motor rotation and Explicit strategy
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- Jun 2016to Apr 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: Alterations in Cerebellar-dependent Adaptation Due to Cannabis Use Measured With an Explicit-implicit Visuo-motor Learning Paradigm
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.
- Conditions
- Cannabis
- Being tested
- Visuo-motor rotation, Explicit strategy
- Keywords
- Learning, Cerebellum
- Medical subject headings
- Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visuo-motor rotationBehavioural
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.
Explicit strategyBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Experimental Explicit | Experimental | Cannabis user performs visuo-motor rotation tasks informed of an explicit strategy to maximise performance Receives: Behavioral: Visuo-motor rotation; Behavioral: Explicit strategy |
| Control Explicit | Active comparator | Healthy subject performs visuo-motor rotation tasks informed of an explicit strategy to maximise performance Receives: Behavioral: Visuo-motor rotation |
| Experimental Implicit | Experimental | Cannabis user performs visuo-motor rotation tasks without being informed of the explicit strategy Receives: Behavioral: Visuo-motor rotation; Behavioral: Explicit strategy |
| Control Implicit | Active comparator | Healthy subject performs visuo-motor rotation tasks without being informed of the explicit strategy Receives: Behavioral: Visuo-motor rotation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Directional error of hand trajectories towards a target
Measured: 1 day (a single session)
Secondary outcomes (2)
Reaction times
Measured: 1 day (a single session)
Intrinsic Motivational Inventory
Measured: 1 day (a single session)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionApr 2017
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CannabisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitat Pompeu Fabra
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Clinic of Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer
- Responsible party
- Principal investigator, Paul Verschure, Universitat Pompeu Fabra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02816034
- Sponsor's protocol ID
- CannabinoidsCerebellum
- Status last verified
- Nov 2018
- First submitted
- 6 Jun 2016
- Last updated
- 5 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 20697860Mazzoni 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.
PubMed 16597717
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alterations in Cerebellar-dependent Adaptation Due to Cannabis Use Measured With an Explicit-implicit Visuo-motor Learning Paradigm
- ClinicalTrials.gov ID
- NCT02816034
- Acronym / sponsor ID
- CannabinoidsCerebellum
- Conditions
- Cannabis
- Keywords
- Learning, Cerebellum
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Universitat Pompeu FabraUniversity, hospital or other
- Collaborators
- Hospital Clinic of Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer
- Study start
- Jun 2016 (actual)
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 28 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Experimental Explicit | Experimental | Behavioral: Visuo-motor rotation, Behavioral: Explicit strategyCannabis user performs visuo-motor rotation tasks informed of an explicit strategy to maximise performance |
| Control Explicit | Active comparator | Behavioral: Visuo-motor rotationHealthy subject performs visuo-motor rotation tasks informed of an explicit strategy to maximise performance |
| Experimental Implicit | Experimental | Behavioral: Visuo-motor rotation, Behavioral: Explicit strategyCannabis user performs visuo-motor rotation tasks without being informed of the explicit strategy |
| Control Implicit | Active comparator | Behavioral: Visuo-motor rotationHealthy subject performs visuo-motor rotation tasks without being informed of the explicit strategy |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Visuo-motor rotationParticipant 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. | Behavioural | Control Explicit, Control Implicit, Experimental Explicit, Experimental Implicit |
| Explicit strategyParticipant is provided with an explicit instruction as to how counteract the effects of the visuo-motor rotation via aiming to a marker adjacent target | Behavioural | Experimental Explicit, Experimental Implicit |
Primary outcome
Directional error of hand trajectories towards a target
Time frame: 1 day (a single session)
2 secondary outcomes
Reaction times
Time frame: 1 day (a single session)
Intrinsic Motivational Inventory
Time frame: 1 day (a single session)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2018.
- Background: PubMed 20697860Taylor 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.
- Background: PubMed 16597717Mazzoni 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.
Related trials for Cannabis
Not yet recruiting
Substance Use and Media Preferences
Substance Use Behavior, Cannabis Intoxication
RecruitingObservational study
Study of an Oral Fluid Testing Approach
Cannabis Use, Cannabis Intoxication
RecruitingPhase 3
Nabilone for Agitation Blinded Intervention Trial
Alzheimer Disease, Agitation
Not yet recruitingPhase 1
PK/PD of Vaping THC-containing Liquids vs. Smoked Cannabis
Cigarette Smoking-Related Carcinoma
Active, not recruitingPhase 1
Psilocybin-assisted Treatment for Cannabis Use Disorder
Cannabis Use Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Visuo-motor rotation and Explicit strategy in people with Cannabis, run by Universitat Pompeu Fabra.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Directional error of hand trajectories towards a target (time frame: 1 day (a single session)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02816034, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2018.