Cannabis IntoxicationPhase 1/2ACSNCT03813602
Detection of Cannabis Impairment With an Eye Tracker
A Phase 1/2 study testing Cannabis Sativa in people with Cannabis Intoxication, run by Centre for Addiction and Mental Health at 1 site in Canada.
Trial summary
Cannabis is one of the widely used psychoactive substances in the world. With increasing legalization, the prevalence of driving under the influence of cannabis will undoubtedly rise. Read more about this study
- Who is it for?
- Ages 19 to 26 yearsHealthy volunteers can take part
- Conditions the study is for
- Cannabis Intoxication
- What is being tested?
- Cannabis Sativa
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- 15 Aug 2019to 15 Nov 2019
- Phase
- Phase 1/2
- 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 19 to 26 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Weekly use of cannabis (1 to 4 days per week) confirmed by urine point-of-care testing;
- 19-26 years of age;
- holds a class G or G2 Ontario driver's licence (or equivalent from another jurisdiction) for at least 12 months;
- Willing to abstain from using alcohol for 48 hours and cannabis for 72 hours prior to the study session;
- Willing to abstain from all other drugs not prescribed for medical purposes for the duration of the study;
- Provides written and informed consent.
Who cannot join
- Urine toxicology screens negative for cannabis upon eligibility assessment;
- Diagnosis of severe medical or psychiatric conditions;
- Females: Pregnancy or breastfeeding;
- Meets criteria for Alcohol or Substance Dependence (current or lifetime) (DSM-IV);
- Is a regular user of medications that affect brain function (i.e., antidepressants, benzodiazepines, stimulants);
- First-degree relative diagnosed with schizophrenia.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Cannabis on Driver Performance and Eye Movements and Characteristics During Simulated Driving: Feasibility Study
Cannabis is one of the widely used psychoactive substances in the world. With increasing legalization, the prevalence of driving under the influence of cannabis will undoubtedly rise. At present, roadside detection of cannabis intoxication is largely dependent on drug recognition experts who rely on changes in eye movements when impaired. In this regard, use of eye trackers can help to detect impairment in drivers. The purpose of the present study is to determine the feasibility of the use of eye trackers in detecting impairment in participants who smoked a cannabis cigarette.
Read the detailed description
Participants will attend one study session after determination of eligibility. During this session, they will smoke a cannabis cigarette with 12.5% THC prior to driving a simulator. Driving will be assessed prior to smoking cannabis and at 7 time points after smoking cannabis. Eye tracking measures will also be taken while driving after smoking cannabis. Blood will be drawn for determination of levels of the psychoactive substance THC and its metabolites. Saliva tests, urine tests and subjective tests will also be performed at various times points after smoking cannabis.
- Conditions
- Cannabis Intoxication
- Being tested
- Cannabis Sativa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cannabis SativaDrug
Also called Marijuana
750 mg cannabis cigarette with 12.5% THC
| Study group | Role | What they receive |
|---|---|---|
| Cannabis sativa | Experimental | a 750 mg cannabis cigarette with 12.5% THC Receives: Drug: Cannabis Sativa |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in eye gaze
Measures of eye movement with an eye tracker
Measured: baseline, 15 minutes, 35 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
Secondary outcomes (22)
Change in saccades
Measures of quick eye movements with an eye tracker
Measured: baseline, 15 minutes, 35 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
Change in eye fixations
Measure of where the eye is looking with an eye tracker
Measured: baseline, 15 minutes, 35 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
Change in blinking rate
The number of blinks, measured with an eye tracker
Measured: baseline, 15 minutes, 35 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
Change in blinking duration
The length of time that blinks last, measured with a eye tracker
Measured: baseline, 15 minutes, 35 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
Change in blinking speed
How fast the blinking is, measured with an eye tracker
Measured: baseline, 15 minutes, 35 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
Change in pupil size
The diameter of pupils while driving, measured with an eye tracker
Measured: baseline, 15 minutes, 35 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
Change in mean speed on the driving simulator
The speed, in km, while driving a driving simulator
Measured: baseline, 15 minutes, 35 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
Change in standard deviation of speed on the driving simulator
The amount of variation in speed while driving the driving simulator
Measured: baseline, 15 minutes, 35 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
Change in maximum speed on the driving simulator
The greatest speed obtained on the driving simulator
Measured: baseline, 15 minutes, 35 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
Change in standard deviation of lateral position on the driving simulator
The amount of weaving while driving the driving simulator
Measured: baseline, 15 minutes, 35 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
Change in minimum time to collision on the driving simulator
The time needed to collide with the car in front, while driving the simulator
Measured: baseline, 15 minutes, 35 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
Change in number of collisions
The number of times a car impacts another car while driving the simulator
Measured: baseline, 15 minutes, 35 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
Change in blood concentrations of delta-9-tetrahydrocannabinol
The levels of the psychoactive component of cannabis, THC, in blood
Measured: baseline, 5 minutes, 25 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
Change in blood concentrations of carboxy-tetrahydrocannabinol
The levels of the inactive metabolite of THC in blood
Measured: baseline, 5 minutes, 25 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
Change in blood concentrations of 11-hydroxy-tetrahydrocannabinol
The levels of the active metabolite of THC in blood
Measured: baseline, 5 minutes, 25 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
Change in saliva THC detection
Detection of THC in saliva
Measured: baseline, 5 minutes, 25 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
Change in systolic blood pressure
Vital signs
Measured: baseline, 5 minutes, 25 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
Change in diastolic blood pressure
Vital signs
Measured: baseline, 5 minutes, 25 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
Change in heart rate
Vital signs
Measured: baseline, 5 minutes, 25 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
Change in temperature
Vital signs
Measured: baseline, 5 minutes, 25 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
Change in number of respirations per minute
Vital signs
Measured: baseline, 5 minutes, 25 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
Change in Subjective cannabis effects with a visual analog scale
The amount of liking of cannabis from 0 to 100, with 100 being the greatest value
Measured: baseline, 5 minutes, 25 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2019
- Study start15 Aug 2019
- Primary completion15 Nov 2019
- Study completion15 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cannabis IntoxicationStudies of the same condition, open and under way.
- More trials run by Centre for Addiction and Mental HealthThe 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 1/2
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bernard Le Foll, MD PhD, Principal investigator, Centre for Addition and Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03813602
- Sponsor's protocol ID
- 076/2018
- Acronym
- ACS
- Status last verified
- Dec 2019
- First submitted
- 16 Jan 2019
- Last updated
- 12 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Shahidi Zandi A, Comeau FJE, Mann RE, Di Ciano P, Arslan EP, Murphy T, Le Foll B, Wickens CM. Preliminary Eye-Tracking Data as a Nonintrusive Marker for Blood Delta-9-Tetrahydrocannabinol Concentration and Drugged Driving. Cannabis Cannabinoid Res. 2021 Dec;6(6):537-547. doi: 10.1089/can.2020.0141. Epub 2021 Aug 24.
PubMed 34432541
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Cannabis on Driver Performance and Eye Movements and Characteristics During Simulated Driving: Feasibility Study
- ClinicalTrials.gov ID
- NCT03813602
- Acronym / sponsor ID
- ACS / 076/2018
- Conditions
- Cannabis Intoxication
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Study start
- 15 Aug 2019 (actual)
- Primary completion
- 15 Nov 2019 (actual)
- Study completion
- 15 Nov 2019 (actual)
- First posted
- 23 Jan 2019 (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.
Cannabis is one of the widely used psychoactive substances in the world. With increasing legalization, the prevalence of driving under the influence of cannabis will undoubtedly rise. At present, roadside detection of cannabis intoxication is largely dependent on drug recognition experts who rely on changes in eye movements when impaired. In this regard, use of eye trackers can help to detect impairment in drivers. The purpose of the present study is to determine the feasibility of the use of eye trackers in detecting impairment in participants who smoked a cannabis cigarette.
Detailed description
Participants will attend one study session after determination of eligibility. During this session, they will smoke a cannabis cigarette with 12.5% THC prior to driving a simulator. Driving will be assessed prior to smoking cannabis and at 7 time points after smoking cannabis. Eye tracking measures will also be taken while driving after smoking cannabis. Blood will be drawn for determination of levels of the psychoactive substance THC and its metabolites. Saliva tests, urine tests and subjective tests will also be performed at various times points after smoking cannabis.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cannabis sativa | Experimental | Drug: Cannabis Sativaa 750 mg cannabis cigarette with 12.5% THC |
Who may qualify
- Ages
- 19 to 26 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Weekly use of cannabis (1 to 4 days per week) confirmed by urine point-of-care testing;
- 19-26 years of age;
- holds a class G or G2 Ontario driver's licence (or equivalent from another jurisdiction) for at least 12 months;
- Willing to abstain from using alcohol for 48 hours and cannabis for 72 hours prior to the study session;
- Willing to abstain from all other drugs not prescribed for medical purposes for the duration of the study;
Key exclusion criteria (6 listed)
- Urine toxicology screens negative for cannabis upon eligibility assessment;
- Diagnosis of severe medical or psychiatric conditions;
- Females: Pregnancy or breastfeeding;
- Meets criteria for Alcohol or Substance Dependence (current or lifetime) (DSM-IV);
- Is a regular user of medications that affect brain function (i.e., antidepressants, benzodiazepines, stimulants);
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 |
|---|---|---|
| Cannabis SativaAlso: Marijuana750 mg cannabis cigarette with 12.5% THC | Drug | Cannabis sativa |
Primary outcome
Change in eye gaze
Time frame: baseline, 15 minutes, 35 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
Measures of eye movement with an eye tracker
22 secondary outcomes
Change in saccades
Time frame: baseline, 15 minutes, 35 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
Change in eye fixations
Time frame: baseline, 15 minutes, 35 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
Change in blinking rate
Time frame: baseline, 15 minutes, 35 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
Change in blinking duration
Time frame: baseline, 15 minutes, 35 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
Change in blinking speed
Time frame: baseline, 15 minutes, 35 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
Change in pupil size
Time frame: baseline, 15 minutes, 35 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
Change in mean speed on the driving simulator
Time frame: baseline, 15 minutes, 35 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
Change in standard deviation of speed on the driving simulator
Time frame: baseline, 15 minutes, 35 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
Change in maximum speed on the driving simulator
Time frame: baseline, 15 minutes, 35 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
Change in standard deviation of lateral position on the driving simulator
Time frame: baseline, 15 minutes, 35 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
Change in minimum time to collision on the driving simulator
Time frame: baseline, 15 minutes, 35 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
Change in number of collisions
Time frame: baseline, 15 minutes, 35 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
Change in blood concentrations of delta-9-tetrahydrocannabinol
Time frame: baseline, 5 minutes, 25 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
Change in blood concentrations of carboxy-tetrahydrocannabinol
Time frame: baseline, 5 minutes, 25 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
Change in blood concentrations of 11-hydroxy-tetrahydrocannabinol
Time frame: baseline, 5 minutes, 25 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
Change in saliva THC detection
Time frame: baseline, 5 minutes, 25 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
Change in systolic blood pressure
Time frame: baseline, 5 minutes, 25 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
Change in diastolic blood pressure
Time frame: baseline, 5 minutes, 25 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
Change in heart rate
Time frame: baseline, 5 minutes, 25 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
Change in temperature
Time frame: baseline, 5 minutes, 25 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
Change in number of respirations per minute
Time frame: baseline, 5 minutes, 25 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
Change in Subjective cannabis effects with a visual analog scale
Time frame: baseline, 5 minutes, 25 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours
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 12 Dec 2019.
- Derived from this study: PubMed 34432541Shahidi Zandi A, Comeau FJE, Mann RE, Di Ciano P, Arslan EP, Murphy T, Le Foll B, Wickens CM. Preliminary Eye-Tracking Data as a Nonintrusive Marker for Blood Delta-9-Tetrahydrocannabinol Concentration and Drugged Driving. Cannabis Cannabinoid Res. 2021 Dec;6(6):537-547. doi: 10.1089/can.2020.0141. Epub 2021 Aug 24.
- Individual participant dataSharing planned: Undecided
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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.
Bernard Le Foll, MD PhD principal investigator
Centre for Addition and Mental Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Cannabis Sativa in people with Cannabis Intoxication, run by Centre for Addiction and Mental Health 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 6 inclusion and 6 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 12 Dec 2019. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change in eye gaze (time frame: baseline, 15 minutes, 35 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours). 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 NCT03813602, which also lists 1 linked publication.
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 12 Dec 2019.