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Age Differences in the Effects of Cannabis on Simulated Driving (ADCUF)

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ClinicalTrials.gov Identifier: NCT04325958
Recruitment Status : Not yet recruiting
First Posted : March 30, 2020
Last Update Posted : January 27, 2021
Sponsor:
Information provided by (Responsible Party):
Centre for Addiction and Mental Health

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.

Condition or disease Intervention/treatment Phase
Cannabis Drug: Cannabis Drug: Placebos Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: The Influence of Age on Driving-related Cannabis Effects: Exploring Cannabis Use Frequency and Related Factors
Estimated Study Start Date : June 2021
Estimated Primary Completion Date : September 2024
Estimated Study Completion Date : September 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Marijuana

Arm Intervention/treatment
Placebo Comparator: Placebo cannabis
Participants will drive the simulator before and after smoking a placebo cannabis cigarette (<1% THC)
Drug: Placebos
750mg cigarette of plant material
Other Name: Dummy

Experimental: Active cannabis
Participants will drive the simulator before and after smoking an active cannabis cigarette (12.5% THC)
Drug: Cannabis
750mg cigarette of plant material
Other Name: Marijuana




Primary Outcome Measures :
  1. Standard deviation of lateral position [ Time Frame: Before cannabis exposure and 30 minutes and 2 hours after cannabis exposure ]
    A measure of 'weaving' when driving the simulator (meters)


Secondary Outcome Measures :
  1. Mean speed [ Time Frame: Before cannabis exposure and 30 minutes and 2 hours after cannabis exposure ]
    A measure of the average speed while driving the simulator (km/hr)

  2. Standard deviation of speed [ Time Frame: Before cannabis exposure and 30 minutes and 2 hours after cannabis exposure ]
    A measure of the variability in speed while driving the simulator (km/hr)

  3. Maximum speed [ Time Frame: Before cannabis exposure and 30 minutes and 2 hours after cannabis exposure ]
    A measure of the greatest speed obtained while driving the simulator (in km/hr)

  4. Minimum time to collision [ Time Frame: Before cannabis exposure and 30 minutes and 2 hours after cannabis exposure ]
    A measure of time it would take to impact the car in front if that car slowed down (seconds)

  5. Following distance [ Time Frame: Before cannabis exposure and 30 minutes and 2 hours after cannabis exposure ]
    A measure of the distance between the car being driven and the car in front (meters)

  6. Braking latency [ Time Frame: Before cannabis exposure and 30 minutes and 2 hours after cannabis exposure ]
    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)

  7. Number of collisions [ Time Frame: Before cannabis exposure and 30 minutes and 2 hours after cannabis exposure ]
    The number of collisions while driving the simulator (total number)

  8. Blood concentration of delta-9-tetrahydrocannabinol (THC) [ Time Frame: Before cannabis exposure and 5, 15, 30 minutes and 1, 2, and 3 hours after cannabis ]
    A measure of the psychoactive component of cannabis in blood (ng/ml)

  9. Blood concentration of carboxy-tetrahydrocannabinol (THC-COOH) [ Time Frame: Before cannabis exposure and 5, 15, 30 minutes and 1, 2, and 3 hours after cannabis ]
    A measure of the inactive metabolite of cannabis in blood (ng/ml)

  10. Blood concentration of 11-hydroxy-tetrahydrocannabinol (11-OH-THC) [ Time Frame: Before cannabis exposure and 5, 15, 30 minutes and 1, 2, and 3 hours after cannabis ]
    A measure of the active metabolite of cannabis in blood (ng/ml)

  11. Systolic blood pressure [ Time Frame: Before cannabis exposure and 5, 15, 30 minutes and 1, 2, 3, 4 and 5 hours after cannabis ]
    A vital sign (mmHg)

  12. Diastolic blood pressure [ Time Frame: Before cannabis exposure and 5, 15, 30 minutes and 1, 2, 3, 4 and 5 hours after cannabis ]
    A vital sign (mmHg)

  13. Heart rate [ Time Frame: Before cannabis exposure and 5, 15, 30 minutes and 1, 2, 3, 4 and 5 hours after cannabis ]
    A vital sign (beats/minute)

  14. Temperature [ Time Frame: Before cannabis exposure and 5, 15, 30 minutes and 1, 2, 3, 4 and 5 hours after cannabis ]
    A vital sign (Celsius)

  15. Respiration rate [ Time Frame: Before cannabis exposure and 5, 15, 30 minutes and 1, 2, 3, 4 and 5 hours after cannabis ]
    A vital sign (respirations/minute)

  16. Visual Analog Scales such as 'I feel this effect', 'I like this drug effect', 'I feel the good effects' [ Time Frame: Before cannabis exposure and 5, 15, 30 minutes and 1, 2, 3, 4 and 5 hours after cannabis ]
    A measure of the subjective effects of cannabis (on a scale of 0 to 100, where is 100 is the strongest level of agreement)

  17. Digit Symbol Substitution Test [ Time Frame: Before cannabis exposure and 70 minutes after cannabis ]
    A measure of the cognitive effects of cannabis (reaction time in seconds)

  18. Verbal Free Recall Task [ Time Frame: Before cannabis exposure and 70 minutes after cannabis ]
    A measure of the cognitive effects of cannabis (number correct)

  19. Useful Field of View Test [ Time Frame: Before cannabis exposure and 70 minutes after cannabis ]
    A measure of the cognitive effects of cannabis (speed of visual processing, in milliseconds)

  20. Grooved Pegboard Test [ Time Frame: Before cannabis exposure and 70 minutes after cannabis ]
    A measure of the cognitive effects of cannabis (performance speed in milliseconds)

  21. Simple and Choice Reaction Time Tasks [ Time Frame: Before cannabis exposure and 70 minutes after cannabis ]
    A measure of the cognitive effects of cannabis (milliseconds)

  22. Vienna Risk-Taking Test [ Time Frame: One hour after cannabis exposure ]
    A measure of the amount of risk-taking (latency)



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04325958


Contacts
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Contact: Christine Wickens, PhD 416 535-8501 ext 34711 christine.wickens@camh.ca
Contact: Patricia Di Ciano, PhD 416 535-8501 ext 34002 patricia.diciano@camh.ca

Locations
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Canada, Ontario
Centre for Addiction and Mental Health
Toronto, Ontario, Canada, M5S 2S1
Contact: Christine Wickens, PhD    416-535-8501 ext 34711    christine.wickens@camh.ca   
Sponsors and Collaborators
Centre for Addiction and Mental Health
Investigators
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Study Director: Bernard Le Foll, MD, PhD Centre for Addiction and Mental Health
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Responsible Party: Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier: NCT04325958    
Other Study ID Numbers: 048/2019
First Posted: March 30, 2020    Key Record Dates
Last Update Posted: January 27, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Marijuana Abuse
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders