Back to resultsAge Differences in the Effects of Cannabis on Simulated Driving (ADCUF)
Primary Purpose
Cannabis
Status
Not yet recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Cannabis
Placebos
Sponsored by
About this trial
This is an interventional basic science trial for Cannabis
Eligibility Criteria
Inclusion Criteria:
- 19-25 or 35-45 years of age;
- Use of smoked cannabis for recreational purposes on up to 2 occasions per week or 5+ occasions per week but on no more than 5 days per week;
- 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 Practice and Test Sessions;
- Willing to abstain from all other drugs not prescribed for medical purposes for the duration of the study;
- Resides within the Metropolitan Toronto area (in which the trial site is located) or can reside with friends/family in the Metropolitan area after a Test Session; this area may be extended to the Greater Toronto area if recruitment challenges arise;
- Provides written and informed consent.
Exclusion Criteria:
- Urine toxicology screens negative for cannabis upon Eligibility Assessment;
- Use of cannabis primarily for therapeutic purposes;
- Diagnosis of medical condition that contraindicates use of cannabis determined by self-report as judged by the Qualified Investigator; this includes a history of hypersensitivity to cannabinoids smoke, respiratory disease and/or severe cardiovascular, cerebrovascular, renal or liver disease. Smoking cannabis is not recommended for patients with respiratory diseases, and they will be excluded
- Diagnosis of psychiatric condition that contraindicates use of cannabis determined by self-report and SCID;
- Females: Pregnancy or breastfeeding;
- Meets criteria for current or lifetime alcohol or other substance use disorder (DSM-5), except tobacco use disorder and caffeine use disorder
- 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.
Sites / Locations
- Centre for Addiction and Mental Health
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo cannabis
Active cannabis
Arm Description
Participants will drive the simulator before and after smoking a placebo cannabis cigarette (<1% THC)
Participants will drive the simulator before and after smoking an active cannabis cigarette (12.5% THC)
Outcomes
Primary Outcome Measures
Standard deviation of lateral position
A measure of 'weaving' when driving the simulator (meters)
Secondary Outcome Measures
Mean speed
A measure of the average speed while driving the simulator (km/hr)
Standard deviation of speed
A measure of the variability in speed while driving the simulator (km/hr)
Maximum speed
A measure of the greatest speed obtained while driving the simulator (in km/hr)
Minimum time to collision
A measure of time it would take to impact the car in front if that car slowed down (seconds)
Following distance
A measure of the distance between the car being driven and the car in front (meters)
Braking latency
A measure of the time it takes to move the foot from the gas pedal to the brake when a stop sign is encountered (seconds)
Number of collisions
The number of collisions while driving the simulator (total number)
Blood concentration of delta-9-tetrahydrocannabinol (THC)
A measure of the psychoactive component of cannabis in blood (ng/ml)
Blood concentration of carboxy-tetrahydrocannabinol (THC-COOH)
A measure of the inactive metabolite of cannabis in blood (ng/ml)
Blood concentration of 11-hydroxy-tetrahydrocannabinol (11-OH-THC)
A measure of the active metabolite of cannabis in blood (ng/ml)
Systolic blood pressure
A vital sign (mmHg)
Diastolic blood pressure
A vital sign (mmHg)
Heart rate
A vital sign (beats/minute)
Temperature
A vital sign (Celsius)
Respiration rate
A vital sign (respirations/minute)
Visual Analog Scales such as 'I feel this effect', 'I like this drug effect', 'I feel the good effects'
A measure of the subjective effects of cannabis (on a scale of 0 to 100, where is 100 is the strongest level of agreement)
Digit Symbol Substitution Test
A measure of the cognitive effects of cannabis (reaction time in seconds)
Verbal Free Recall Task
A measure of the cognitive effects of cannabis (number correct)
Useful Field of View Test
A measure of the cognitive effects of cannabis (speed of visual processing, in milliseconds)
Grooved Pegboard Test
A measure of the cognitive effects of cannabis (performance speed in milliseconds)
Simple and Choice Reaction Time Tasks
A measure of the cognitive effects of cannabis (milliseconds)
Vienna Risk-Taking Test
A measure of the amount of risk-taking (latency)
Full Information
NCT ID
NCT04325958
First Posted
March 26, 2020
Last Updated
December 1, 2022
Sponsor
Centre for Addiction and Mental Health
1. Study Identification
Unique Protocol Identification Number
NCT04325958
Brief Title
Age Differences in the Effects of Cannabis on Simulated Driving
Acronym
ADCUF
Official Title
The Influence of Age on Driving-related Cannabis Effects: Exploring Cannabis Use Frequency and Related Factors
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 2023 (Anticipated)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre for Addiction and Mental Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
Epidemiological studies have established that the use of cannabis can increase the risk of a motor vehicle collision. A number of variables can influence the effects of cannabis on driving. For example, frequent users of cannabis have been shown to have different cognitive and physiological responses to cannabis as compared to occasional users. In addition, we know that younger drivers are more likely to be involved in motor vehicle collisions after alcohol use as compared to older users. The contribution of age and experience with cannabis on cannabis-mediated effects on driving have yet to be delineated in laboratory studies. The purpose of the present investigation will be to determine whether cannabis has different effects on driving in young, as compared to middle aged, drivers. Half of each age group will be occasional users of cannabis and the other half will be frequent users.
Eligible participants will attend the laboratory for two test sessions; in one session they will smoke a cannabis cigarette and in the other they smoke a placebo cigarette. Participants will drive a driving simulator before and after smoking the cigarette. Blood for measurement of THC and metabolites will also be collected before smoking the cigarette and at a number of times after smoking. Subjective and cognitive tasks will be completed before and after smoking.
It is hoped that the findings of this study will help to inform public perception and policy into the potential effects of cannabis on driving.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cannabis
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
128 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Placebo cannabis
Arm Type
Placebo Comparator
Arm Description
Participants will drive the simulator before and after smoking a placebo cannabis cigarette (<1% THC)
Arm Title
Active cannabis
Arm Type
Experimental
Arm Description
Participants will drive the simulator before and after smoking an active cannabis cigarette (12.5% THC)
Intervention Type
Drug
Intervention Name(s)
Cannabis
Other Intervention Name(s)
Marijuana
Intervention Description
750mg cigarette of plant material
Intervention Type
Drug
Intervention Name(s)
Placebos
Other Intervention Name(s)
Dummy
Intervention Description
750mg cigarette of plant material
Primary Outcome Measure Information:
Title
Standard deviation of lateral position
Description
A measure of 'weaving' when driving the simulator (meters)
Time Frame
Before cannabis exposure and 30 minutes and 2 hours after cannabis exposure
Secondary Outcome Measure Information:
Title
Mean speed
Description
A measure of the average speed while driving the simulator (km/hr)
Time Frame
Before cannabis exposure and 30 minutes and 2 hours after cannabis exposure
Title
Standard deviation of speed
Description
A measure of the variability in speed while driving the simulator (km/hr)
Time Frame
Before cannabis exposure and 30 minutes and 2 hours after cannabis exposure
Title
Maximum speed
Description
A measure of the greatest speed obtained while driving the simulator (in km/hr)
Time Frame
Before cannabis exposure and 30 minutes and 2 hours after cannabis exposure
Title
Minimum time to collision
Description
A measure of time it would take to impact the car in front if that car slowed down (seconds)
Time Frame
Before cannabis exposure and 30 minutes and 2 hours after cannabis exposure
Title
Following distance
Description
A measure of the distance between the car being driven and the car in front (meters)
Time Frame
Before cannabis exposure and 30 minutes and 2 hours after cannabis exposure
Title
Braking latency
Description
A measure of the time it takes to move the foot from the gas pedal to the brake when a stop sign is encountered (seconds)
Time Frame
Before cannabis exposure and 30 minutes and 2 hours after cannabis exposure
Title
Number of collisions
Description
The number of collisions while driving the simulator (total number)
Time Frame
Before cannabis exposure and 30 minutes and 2 hours after cannabis exposure
Title
Blood concentration of delta-9-tetrahydrocannabinol (THC)
Description
A measure of the psychoactive component of cannabis in blood (ng/ml)
Time Frame
Before cannabis exposure and 5, 15, 30 minutes and 1, 2, and 3 hours after cannabis
Title
Blood concentration of carboxy-tetrahydrocannabinol (THC-COOH)
Description
A measure of the inactive metabolite of cannabis in blood (ng/ml)
Time Frame
Before cannabis exposure and 5, 15, 30 minutes and 1, 2, and 3 hours after cannabis
Title
Blood concentration of 11-hydroxy-tetrahydrocannabinol (11-OH-THC)
Description
A measure of the active metabolite of cannabis in blood (ng/ml)
Time Frame
Before cannabis exposure and 5, 15, 30 minutes and 1, 2, and 3 hours after cannabis
Title
Systolic blood pressure
Description
A vital sign (mmHg)
Time Frame
Before cannabis exposure and 5, 15, 30 minutes and 1, 2, 3, 4 and 5 hours after cannabis
Title
Diastolic blood pressure
Description
A vital sign (mmHg)
Time Frame
Before cannabis exposure and 5, 15, 30 minutes and 1, 2, 3, 4 and 5 hours after cannabis
Title
Heart rate
Description
A vital sign (beats/minute)
Time Frame
Before cannabis exposure and 5, 15, 30 minutes and 1, 2, 3, 4 and 5 hours after cannabis
Title
Temperature
Description
A vital sign (Celsius)
Time Frame
Before cannabis exposure and 5, 15, 30 minutes and 1, 2, 3, 4 and 5 hours after cannabis
Title
Respiration rate
Description
A vital sign (respirations/minute)
Time Frame
Before cannabis exposure and 5, 15, 30 minutes and 1, 2, 3, 4 and 5 hours after cannabis
Title
Visual Analog Scales such as 'I feel this effect', 'I like this drug effect', 'I feel the good effects'
Description
A measure of the subjective effects of cannabis (on a scale of 0 to 100, where is 100 is the strongest level of agreement)
Time Frame
Before cannabis exposure and 5, 15, 30 minutes and 1, 2, 3, 4 and 5 hours after cannabis
Title
Digit Symbol Substitution Test
Description
A measure of the cognitive effects of cannabis (reaction time in seconds)
Time Frame
Before cannabis exposure and 70 minutes after cannabis
Title
Verbal Free Recall Task
Description
A measure of the cognitive effects of cannabis (number correct)
Time Frame
Before cannabis exposure and 70 minutes after cannabis
Title
Useful Field of View Test
Description
A measure of the cognitive effects of cannabis (speed of visual processing, in milliseconds)
Time Frame
Before cannabis exposure and 70 minutes after cannabis
Title
Grooved Pegboard Test
Description
A measure of the cognitive effects of cannabis (performance speed in milliseconds)
Time Frame
Before cannabis exposure and 70 minutes after cannabis
Title
Simple and Choice Reaction Time Tasks
Description
A measure of the cognitive effects of cannabis (milliseconds)
Time Frame
Before cannabis exposure and 70 minutes after cannabis
Title
Vienna Risk-Taking Test
Description
A measure of the amount of risk-taking (latency)
Time Frame
One hour after cannabis exposure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
19-25 or 35-45 years of age;
Use of smoked cannabis for recreational purposes on up to 2 occasions per week or 5+ occasions per week but on no more than 5 days per week;
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 Practice and Test Sessions;
Willing to abstain from all other drugs not prescribed for medical purposes for the duration of the study;
Resides within the Metropolitan Toronto area (in which the trial site is located) or can reside with friends/family in the Metropolitan area after a Test Session; this area may be extended to the Greater Toronto area if recruitment challenges arise;
Provides written and informed consent.
Exclusion Criteria:
Urine toxicology screens negative for cannabis upon Eligibility Assessment;
Use of cannabis primarily for therapeutic purposes;
Diagnosis of medical condition that contraindicates use of cannabis determined by self-report as judged by the Qualified Investigator; this includes a history of hypersensitivity to cannabinoids smoke, respiratory disease and/or severe cardiovascular, cerebrovascular, renal or liver disease. Smoking cannabis is not recommended for patients with respiratory diseases, and they will be excluded
Diagnosis of psychiatric condition that contraindicates use of cannabis determined by self-report and SCID;
Females: Pregnancy or breastfeeding;
Meets criteria for current or lifetime alcohol or other substance use disorder (DSM-5), except tobacco use disorder and caffeine use disorder
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christine Wickens, PhD
Phone
416 535-8501
Ext
34711
Email
christine.wickens@camh.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Patricia Di Ciano, PhD
Phone
416 535-8501
Ext
34002
Email
patricia.diciano@camh.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bernard Le Foll, MD, PhD
Organizational Affiliation
Centre for Addiction and Mental Health
Official's Role
Study Director
Facility Information:
Facility Name
Centre for Addiction and Mental Health
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5S 2S1
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christine Wickens, PhD
Phone
416-535-8501
Ext
34711
Email
christine.wickens@camh.ca
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Age Differences in the Effects of Cannabis on Simulated Driving
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