Cannabis Edibles for Driving Performance

BL
MW
Overseen ByMadison Wright, PhD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different doses of cannabis edibles affect driving skills using a simulator. Researchers aim to determine if higher doses worsen driving performance. They also examine how cannabis impacts memory, mood, and other mental functions, and how THC levels in the body relate to these effects. Individuals who use cannabis recreationally at least once a week and have held a driver's license for over a year may be suitable for this trial. As an unphased trial, it offers participants the chance to contribute to important research on cannabis use and its effects on driving and mental functions.

Do I have to stop taking my current medications for the trial?

The trial requires you to stop using all drugs not medically required for the duration of the study, starting 48 hours before the practice session. If you regularly use medication that affects cognitive functioning or driver performance, you may not be eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that cannabis edibles, which contain THC (the component that causes a high), can impair driving ability. Users have reported changes in thinking, behavior, and body functions after consumption.

1. **Low Dose (2 mg THC):** Although most studies focus on higher doses, even small amounts of THC can affect driving and thinking. These effects are usually milder than those from higher doses.

2. **Medium Dose (10 mg THC):** This common amount in edible products can noticeably impair driving and thinking. Regulators often recommend this as the maximum amount per serving to reduce risk.

3. **High Dose (20 mg THC):** At this higher dose, THC has a stronger impact. Studies have shown it can significantly impair driving skills and cognitive abilities, with recovery taking about 5 to 7 hours after consumption.

Prospective trial participants should remember that the effects of THC from edibles can last longer than when smoked. Always exercise caution and be aware of personal reactions to THC.12345

Why are researchers excited about this trial?

Researchers are excited about the use of cannabis edibles to assess driving performance because this approach offers a new perspective on how THC levels affect drivers. Unlike traditional methods that might use smoked or vaporized cannabis, edibles provide a controlled and precise way to administer THC, allowing for a more accurate measurement of its impact on driving. The trial includes varying doses, from low (2 mg THC) to high (20 mg THC), which helps in understanding the spectrum of effects THC can have, offering insights into safe consumption levels for drivers. Additionally, the inclusion of a placebo group (0 mg THC) allows for clear comparisons to be made, enhancing the reliability of the results.

What evidence suggests that this trial's treatments could be effective for driving performance?

This trial will compare the effects of different doses of cannabis edibles on driving performance. Studies have shown that cannabis, especially THC (the ingredient that causes a high), can affect driving. Participants in this trial may receive low-dose cannabis edibles (2 mg THC), which research suggests might cause slight changes, like driving a bit slower, but not major issues like swerving. Those receiving medium doses (10 mg THC) may experience minimal effects, such as a small impact on speed and lane maintenance. Participants consuming high doses (20 mg THC) may show more noticeable effects, with increased difficulty in tasks requiring focus. Overall, higher THC levels in edibles are linked to more significant effects on driving abilities.16789

Who Is on the Research Team?

Pharmacology and Toxicology

Bernard Le Foll, MD

Principal Investigator

Centre for Addiction and Mental Health

Are You a Good Fit for This Trial?

This trial is for people who use cannabis recreationally. Participants must be healthy, with no history of substance abuse other than cannabis, and not currently taking any medications that could affect driving performance. Pregnant or breastfeeding individuals cannot participate.

Inclusion Criteria

Willing to abstain from using cannabis for 72 hours prior to each practice or test session
Provides written and informed consent
Use of appropriate contraception for those with childbearing potential
See 8 more

Exclusion Criteria

I have heart or brain blood vessel disease.
Severe laboratory abnormalities that could create safety issues
I regularly take medication that could affect my thinking or driving.
See 8 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants consume cannabis edibles at varying doses and undergo driving simulator tests and physiological assessments

4 sessions
4 visits (in-person)

Follow-up

Participants are monitored for residual effects 24 hours after dosing

1 day
1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Cannabis Edibles
Trial Overview The study tests how different doses of orally taken cannabis edibles (placebo, low, medium, high) affect driving on a simulator. It also looks at the effects on mood, memory and behavior up to 24 hours later and measures THC levels in body fluids.
How Is the Trial Designed?
4Treatment groups
Experimental Treatment
Group I: Placebo Cannabis Edibles (0 mg THC)Experimental Treatment1 Intervention
Group II: Medium Dose Cannabis Edibles (10 mg)Experimental Treatment1 Intervention
Group III: Low Dose Cannabis Edibles (2 mg THC)Experimental Treatment1 Intervention
Group IV: High Dose Cannabis Edibles (20 mg)Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Centre for Addiction and Mental Health

Lead Sponsor

Trials
388
Recruited
84,200+

Citations

The effect of cannabis edibles on driving and blood THCCannabis has been shown to impact driving due to changes produced by delta-9-tetrahydrocannabinol (THC), the psychoactive component of cannabis.
Study Finds No Significant Changes In Driving Performance...Edibles contained, on average, 7.3 mg of THC. Subjects' driving performance was assessed at two, four, and six hours. Study participants were ...
3.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/38822413/
The effect of cannabis edibles on driving and blood THCCompared to control, cannabis edibles produced a decrease in mean speed 2 h after consumption but not at 4 and 6 h. Under dual task conditions ...
Cannabis Effects on Driving Performance: Clinical ...Media coverage of this study conveyed the findings as CBD-dominant cannabis not causing driving impairment while THC-dominant cannabis does, ...
Tasty THC: Promises and Challenges of Cannabis EdiblesMore recently, Cooper and colleagues (2013) found that, while a high dose. (20 milligrams [mg]) of dronabinol resulted in a. “high” that was liked and resulted ...
NCT06595576 | Cannabis Edibles and Simulated DrivingFour conditions will be tested: placebo, low dose, medium dose and high dose. Driving performance will be tested objectively using a driving simulator during a ...
Driving Performance and Cannabis Users' Perception of ...Acute consumption of Δ9-tetrahydrocannabinol (THC) negatively affects cognitive functioning and reduces driving performance, particularly in ...
Impact of cannabis‐infused edibles on public safety and ...Fatalities involving cannabis and alcohol impairment while driving jumped from 4.8% in 2000 to 10.3% in 2018 [14]. In Colorado alone, traffic ...
tetrahydrocannabinol (Δ 9 -THC)-induced driving and ...Most driving-related skills are predicted to recover within ∼5-hs (and almost all within ∼7-hs) of inhaling 20 mg Δ 9 -THC.
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