Cannabis Edibles for Driving Performance

Overseen By Madison Wright, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Centre for Addiction and Mental Health

Must not be taking: ADHD medication, Benzodiazepines, Opioids

Disqualifiers: Severe medical condition, Substance use disorder, Schizophrenia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 4 sessions

52 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this human laboratory experiment is to determine the acute and residual effects of a range of doses of orally administered cannabis edibles on driving simulator performance in people who use cannabis recreationally. Four conditions will be tested: placebo, low dose, medium dose and high dose. Driving performance will be tested objectively using a driving simulator during a number of pre-programmed driving scenarios. The investigators will test the hypothesis that driving performance on a high-fidelity driving simulator will decrease with increasing doses of cannabis. Secondary objectives will: * Determine the acute and residual (24 hour) cognitive, behavioural, and physiological effects of a range of doses of orally administered cannabis edibles on subjective effects, cognitive tests, verbal memory, and mood. * Examine how the concentration of THC in blood and oral fluids correlates with driving simulator performance, as well as cognitive, behavioural, and physiological measures. Cannabinoid levels in blood, urine and oral fluids will be measured at baseline and over a 5 hour period following drug exposure. The investigators will examine the relationship between cannabinoid levels and performance measures in this time frame. * Explore potential biomarkers of acute exposure to cannabis edibles by analyzing the following: circulating cell-free mtDNA (ccf-mtDNA), endocannabinoids, and metabolic biomarkers.

Research Team

Bernard Le Foll, MD

Principal Investigator

Centre for Addiction and Mental Health

Eligibility Criteria

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

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.

Timeline

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)

Treatment Details

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.

Participant Groups

Group I: Placebo Cannabis Edibles (0 mg THC) Experimental Treatment 1 Intervention

Participants consume a placebo dose of cannabis edibles (0 mg THC).

Group II: Medium Dose Cannabis Edibles (10 mg) Experimental Treatment 1 Intervention

Participants consume a medium dose of cannabis edibles (10 mg THC).

Group III: Low Dose Cannabis Edibles (2 mg THC) Experimental Treatment 1 Intervention

Participants consume a low dose of cannabis edibles (2 mg THC).

Group IV: High Dose Cannabis Edibles (20 mg) Experimental Treatment 1 Intervention

Participants consume a high dose of cannabis edibles (20 mg THC).

Who Is Running the Clinical Trial?

Centre for Addiction and Mental Health

Lead Sponsor

Trials

388

Recruited

84,200+