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Recruiting
View on ClinicalTrials.gov

Comparing Cannabis with Placebos for cannabis

Official title: Age Differences in the Effects of Cannabis on Simulated Driving

The Influence of Age on Driving-related Cannabis Effects: Exploring Cannabis Use Frequency and Related Factors

Condition: CannabisSponsor: Centre for Addiction and Mental HealthTarget enrollment: 128
  • 2 groups
  • One site, in Toronto
  • Recruiting
Centre for Addiction and Mental Health, Toronto, Ontario

Interventions

  • Medication

    Cannabis

    750mg cigarette of plant material

  • Medication

    Placebos

    750mg cigarette of plant material

Canadian Sites (1)

1 of 1 recruiting

  • Centre for Addiction and Mental Health

    Toronto, Ontario

    Recruiting

Eligibility Criteria

See who this study is looking for30 criteria

The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.

Inclusion

  • +19-25 or 35-45 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 24 hours and cannabis for 72 hours prior to Practice and Test Sessions;
  • +Willing to abstain from all other drugs not prescribed for medical purposes for 48 hours prior to Practice and Test Sessions;
  • +Resides within Toronto (study siteTrial siteA hospital or clinic where a study is actually run.Read more →) or can reside with friends/family in Toronto after a Test Session; this area may be extended to the Greater Toronto area if recruitment challenges arise;
  • +Provides written and informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →.
  • +Exclusion CriteriaExclusion criteriaThe things that would prevent someone from taking part.Read more →
  • +Use of cannabis primarily for therapeutic purposes, or equally for therapeutic and recreational purposes;
  • +Diagnosis of psychiatric condition that contraindicates use of cannabis determined by self-report or SCID-5;
  • +Is a regular user of medications that affect brain function (based on self-report); this includes concomitant therapy with sedative-hypnotics or other psychoactive drugs
  • +Use of anti-hypertensives;
  • +First-degree relative diagnosed with schizophrenia or another psychotic disorder.
  • +Participation in a past driving study at CAMH (to limit practice effects).
  • +Participation in a clinical study concurrent with their participation in this study.
  • +Participant willing to use appropriate contraception until their participation in the study is completed;
  • +Participants of childbearing potential: Pregnancy (point-of-care test) or breastfeeding;
  • +Use of smoked cannabis at least once in the past 6 months.
  • +Use of smoked or vaped cannabis primarily for recreational purposes on up to 1 day per week or on at least 6 days per week in the past 3 months;
  • +Diagnosis of medical condition that contraindicates use of cannabis determined by self-report as judged by the Principal InvestigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more → and a study physician; this includes a history of hypersensitivity to cannabinoids smoke, respiratory disease and/or severe cardiovascular, cerebrovascular, renal or liver disease, and bleeding disorders. Smoking cannabis is not recommended for individuals with respiratory diseases, and they will be excluded;
  • +Meets criteria for current or lifetime alcohol or other substance use disorder (DSM-5), except tobacco use disorder and caffeine use disorder;

Exclusion

  • Use of cannabis primarily for therapeutic purposes, or equally for therapeutic and recreational purposes;
  • Diagnosis of psychiatric condition that contraindicates use of cannabis determined by self-report or SCID-5;
  • Is a regular user of medications that affect brain function (based on self-report); this includes concomitant therapy with sedative-hypnotics or other psychoactive drugs
  • Use of anti-hypertensives;
  • First-degree relative diagnosed with schizophrenia or another psychotic disorder.
  • Participation in a past driving study at CAMH (to limit practice effects).
  • Participation in a clinical study concurrent with their participation in this study.
  • Participants of childbearing potential: Pregnancy (point-of-care test) or breastfeeding;
  • Diagnosis of medical condition that contraindicates use of cannabis determined by self-report as judged by the Principal InvestigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more → and a study physician; this includes a history of hypersensitivity to cannabinoids smoke, respiratory disease and/or severe cardiovascular, cerebrovascular, renal or liver disease, and bleeding disorders. Smoking cannabis is not recommended for individuals with respiratory diseases, and they will be excluded;
  • Meets criteria for current or lifetime alcohol or other substance use disorder (DSM-5), except tobacco use disorder and caffeine use disorder;
5 concepts to explore on this page · up to 1,300 pointsTap any term to learn what it means.

In plain language

Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.

Learning 
What this study is

This study is investigating how something functions in the body, rather than testing a treatment directly.

This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.

From the trial registry

Built from these fields:

  • designModule.designInfo.primaryPurpose
  • designModule.phases
Who receives what

There are 2 groups in this study.

Groups A and B receive one or more of: Cannabis and PlacebosPlaceboA dummy treatment with no active medicine, used for comparison.Read more →.

Registry label: A: Age group 19 to 25 · B: Age group 35 to 45

From the trial registry

Built from these fields:

  • armsInterventionsModule.armGroups[].label
  • armsInterventionsModule.armGroups[].type
  • armsInterventionsModule.armGroups[].interventionNames
How the study is run

Groups are assigned by the study team using set rules, rather than by chance.

Neither you nor the study team would know which group you are in until the study ends.

From the trial registry

Built from these fields:

  • designModule.designInfo.allocation
  • designModule.designInfo.maskingInfo.masking
Is there a placebo?

This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.

From the trial registry

Built from these fields:

  • armsInterventionsModule.armGroups[].type
  • armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for

The study lists an age range of 19 years to 45 years.

The study is open to people of any sex.

The study accepts healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more → as well as people with the condition.

These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.

From the trial registry

Built from these fields:

  • eligibilityModule.minimumAge
  • eligibilityModule.maximumAge
  • eligibilityModule.sex
  • eligibilityModule.healthyVolunteers
How big and how long

The study aims to enrol about 128 people.

The study is currently expected to finish around March 2027.

The main measurement is taken over: Before cannabis exposure and 30 minutes and 2 hours after cannabis exposure.

From the trial registry

Built from these fields:

  • designModule.enrollmentInfo.count
  • statusModule.completionDateStruct.date
  • outcomesModule.primaryOutcomes[].timeFrame
What the study measures

Standard deviation of lateral position — measured over Before cannabis exposure and 30 minutes and 2 hours after cannabis exposure.

From the trial registry

Built from these fields:

  • outcomesModule.primaryOutcomes[].measure
  • outcomesModule.primaryOutcomes[].timeFrame

Source: NCT04325958 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.

Not medical advice. What do these terms mean?

What is being tested — in plain terms

About CannabisDrug

750mg cigarette of plant material

From the trial registry — its own words, unedited.

What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.

Read the full explanation → · in clinical review

About PlacebosDrug

750mg cigarette of plant material

From the trial registry — its own words, unedited.

What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.

Read the full explanation → · in clinical review

Common questions

Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.

Am I eligible for this trial?

Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.

What the study lists: an age range of 19 years to 45 years.

The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.

The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.

From the trial registry
  • eligibilityModule.minimumAge
  • eligibilityModule.maximumAge
  • eligibilityModule.eligibilityCriteria
Is there a placebo?

This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.

From the trial registry
  • armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?

Neither you nor the study team would know which group you are in until the study ends.

Groups are assigned by the study team using set rules, rather than by chance.

From the trial registry
  • designModule.designInfo.maskingInfo.masking
  • designModule.designInfo.allocation
Who can join?

The study lists an age range of 19 years to 45 years.

It is open to people of any sex.

It accepts healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more → as well as people with the condition.

Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.

From the trial registry
  • eligibilityModule.minimumAge
  • eligibilityModule.maximumAge
  • eligibilityModule.sex
  • eligibilityModule.healthyVolunteers
How long would this take?

The study's main measurement is taken over: Before cannabis exposure and 30 minutes and 2 hours after cannabis exposure.

The study as a whole is currently expected to finish around 2027-03.

How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.

From the trial registry
  • outcomesModule.primaryOutcomes[].timeFrame
  • statusModule.completionDateStruct.date
How many people are taking part?

The study aims to enrol about 128 people.

From the trial registry
  • designModule.enrollmentInfo.count
Where is this happening?

This study lists one location: Toronto, Ontario, Canada.

Sites can open and close during a study, so confirm with the team before travelling.

From the trial registry
  • trial_locations

About This Trial

Epidemiological studies suggest that the use of cannabis is associated with an increase in the risk of motor vehicle collisions. It is also known that younger users may be at increased risk for motor vehicle collisions. Further, the frequency with which cannabis is used may be an important variable in determining the effects of cannabis on driving. The purpose of the present study will be to investigate the effects of cannabis on simulated driving in young as compared to middle-aged drivers. Half of the participants will be occasional users of cannabis and half will be frequent users of cannabis.

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This page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.