Cannabis UsePhase 1NCT03581058
Neural Correlates of Driving and Cannabis
A Phase 1 study testing Cannabis in people with Cannabis Use and Driving Impaired, run by Unity Health Toronto at 1 site in Canada.
Trial summary
Driving is a set of complex tasks and requires use of multiple cognitive domains, including attention, planning, and memory. In laboratory studies, the main psychoactive component in cannabis, delta-9-tetrahydrocannabinol (THC), was shown to impair short-term memory, attention, reaction time, tracking, and… Read more about this study
- Who is it for?
- Ages 25 to 59 years
- Conditions the study is for
- Cannabis Use, Driving Impaired
- What is being tested?
- Cannabis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteCanada
- Study dates
- 8 Aug 2018to 31 Dec 2020
- Phase
- Phase 1
- 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 25 to 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- valid driver's license
- have normal or corrected-to-normal vision
- have had prior experience consuming cannabis
- are currently not and have not been regular users in the past 5 years (regular use is defined as at least 1 time per week for at least 1 month)
- prescribed medical cannabis
Who cannot join
- not fluent in English
- do not meet MRI screening criteria
- use 50 mg/day of morphine equivalents
- history of neurological, neurodegenerative or psychiatric diseases
- any serious sensory or motor impairments
- pregnant women or women trying to get pregnant, or breastfeeding
- serious lung, liver, kidney, and heart problems, including angina, coronary artery disease, and arrhythmia, and Peripheral Vascular Disease
- personal or family history of mental disorders or alcohol or drug abuse or dependence
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigating the Neural Correlates of Driving After Medical Cannabis Exposure
Driving is a set of complex tasks and requires use of multiple cognitive domains, including attention, planning, and memory. In laboratory studies, the main psychoactive component in cannabis, delta-9-tetrahydrocannabinol (THC), was shown to impair short-term memory, attention, reaction time, tracking, and coordination, resulting, for instance, in significantly more deviations from the lane and increased break latency. Surveys and epidemiological studies suggest that cannabis consumption is associated with increased risks of collision.
The current study aims to evaluate individual driving behavior and performance on various neurocognitive tests and their correlated neural networks while under the influence of cannabis and while sober. The investigators will use the STISIM driving simulator, which is fully MRI compatible, to study brain activation, while participants are performing various driving maneuvers.
Read more
The goals of the study are:
- identify driving performance and patterns in brain activation associated with cannabis exposure and compare them to brain patterns of the same participants while sober;
- compare participant's performance on cognitive tasks while under the influence of cannabis and sober;
- look for correlations between concentration of cannabinoids in the participants' blood and their driving performance and performance on cognitive tasks;
- correlate demographic variables and personal history (e.g. tolerance to drug) with performance and brain activation while driving under the influence of cannabis.
- Conditions
- Cannabis Use, Driving Impaired
- Being tested
- Cannabis
- Keywords
- MRI, Cannabis, Driving
- Medical subject headings
- Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CannabisDrug
Also called Marijuana
Participants will be assigned to consume one of the cannabis strains and will complete testing immediately after consumption.
| Study group | Role | What they receive |
|---|---|---|
| Cannabis - Jean Guy | Experimental | A participant will be administered 1g of Jean Guy strain of cannabis. Receives: Drug: Cannabis |
| Cannabis - Churchill | Experimental | A participant will be administered 1g of Churchill strain of cannabis. Receives: Drug: Cannabis |
| Sober | No intervention | All participants will complete same tasks sober. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in neural activation on fMRI during driving simulation
Neural activation, based on BOLD signal, while completing driving tasks under the influence of cannabis and sober.
Measured: 30-60 min after cannabis intake vs sober
Secondary outcomes (3)
Performance on driving simulator
Number of errors while completing driving tasks (e.g. turning, driving straight, speed maintenance, missed stop signs, etc.) under the influence of cannabis and sober.
Measured: 30-60 min after cannabis intake vs sober
Performance on cognitive tasks
Cognitive test battery to assess various driving-related cognitive functions: attention, working memory, visual-spatial processing, processing speed, etc.
Measured: 60-90 min after cannabis intake vs sober
Blood plasma concentration levels of cannabinoids
Concentration levels of THC and CBD throughout the session duration
Measured: 10 min and 60 min after cannabis intake
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2018
- Study start8 Aug 2018
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cannabis UseStudies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- University Health Network, Toronto
- Responsible party
- Sponsor
- Investigators
- Tom Schweizer, PhD, Principal investigator, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03581058
- Sponsor's protocol ID
- 17-206
- Status last verified
- Mar 2020
- First submitted
- 6 Jun 2018
- Last updated
- 23 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Neural Correlates of Driving After Medical Cannabis Exposure
- ClinicalTrials.gov ID
- NCT03581058
- Acronym / sponsor ID
- 17-206
- Conditions
- Cannabis Use, Driving Impaired
- Keywords
- MRI, Cannabis, Driving
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Collaborators
- University Health Network, Toronto
- Study start
- 8 Aug 2018 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 10 Jul 2018 (actual)
- 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.
Driving is a set of complex tasks and requires use of multiple cognitive domains, including attention, planning, and memory. In laboratory studies, the main psychoactive component in cannabis, delta-9-tetrahydrocannabinol (THC), was shown to impair short-term memory, attention, reaction time, tracking, and coordination, resulting, for instance, in significantly more deviations from the lane and increased break latency. Surveys and epidemiological studies suggest that cannabis consumption is associated with increased risks of collision.
The current study aims to evaluate individual driving behavior and performance on various neurocognitive tests and their correlated neural networks while under the influence of cannabis and while sober. The investigators will use the STISIM driving simulator, which is fully MRI compatible, to study brain activation, while participants are performing various driving maneuvers.
The goals of the study are:
- identify driving performance and patterns in brain activation associated with cannabis exposure and compare them to brain patterns of the same participants while sober;
- compare participant's performance on cognitive tasks while under the influence of cannabis and sober;
- look for correlations between concentration of cannabinoids in the participants' blood and their driving performance and performance on cognitive tasks;
- correlate demographic variables and personal history (e.g. tolerance to drug) with performance and brain activation while driving under the influence of cannabis.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cannabis - Jean Guy | Experimental | Drug: CannabisA participant will be administered 1g of Jean Guy strain of cannabis. |
| Cannabis - Churchill | Experimental | Drug: CannabisA participant will be administered 1g of Churchill strain of cannabis. |
| Sober | No intervention | –All participants will complete same tasks sober. |
Who may qualify
- Ages
- 25 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- valid driver's license
- have normal or corrected-to-normal vision
- have had prior experience consuming cannabis
- are currently not and have not been regular users in the past 5 years (regular use is defined as at least 1 time per week for at least 1 month)
- prescribed medical cannabis
Key exclusion criteria (8 listed)
- not fluent in English
- do not meet MRI screening criteria
- use 50 mg/day of morphine equivalents
- history of neurological, neurodegenerative or psychiatric diseases
- any serious sensory or motor impairments
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 |
|---|---|---|
| CannabisAlso: MarijuanaParticipants will be assigned to consume one of the cannabis strains and will complete testing immediately after consumption. | Drug | Cannabis - Churchill, Cannabis - Jean Guy |
Primary outcome
Change in neural activation on fMRI during driving simulation
Time frame: 30-60 min after cannabis intake vs sober
Neural activation, based on BOLD signal, while completing driving tasks under the influence of cannabis and sober.
3 secondary outcomes
Performance on driving simulator
Time frame: 30-60 min after cannabis intake vs sober
Performance on cognitive tasks
Time frame: 60-90 min after cannabis intake vs sober
Blood plasma concentration levels of cannabinoids
Time frame: 10 min and 60 min after cannabis intake
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2020.
- Individual participant dataSharing planned: No
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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.
Tom Schweizer, PhD principal investigator
Unity Health Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cannabis in people with Cannabis Use and Driving Impaired, run by Unity Health Toronto at 1 site in Canada.
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 5 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 23 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Change in neural activation on fMRI during driving simulation (time frame: 30-60 min after cannabis intake vs sober). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Mar 2020.