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Cannabis Effects on Driving Performance (ADCUF Trial)

N/A

Recruiting

Led By Christine Wickens, PhD

Research Sponsored by Centre for Addiction and Mental Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

19-25 or 35-45 years of age;

19-25 or 35-45 years of age

Must not have

Females: Pregnancy or breastfeeding

Diagnosis of psychiatric condition that contraindicates use of cannabis determined by self-report and SCID

Timeline

Screening 3 weeks

Treatment Varies

Follow Up one hour after cannabis exposure

Summary

This trial will study the effects of cannabis on driving in young vs. middle-aged drivers who are occasional or frequent users of cannabis.

Who is the study for?

This trial is for occasional or frequent cannabis users aged 19-25 or 35-45 with a valid driver's license. Participants must not use alcohol or drugs other than prescribed ones before sessions and live in the Toronto area. Pregnant women, those with certain health conditions, and regular users of brain-affecting meds cannot join.

What is being tested?

The study examines how cannabis affects simulated driving performance in young versus middle-aged drivers. It compares the effects between occasional and frequent cannabis users using placebos as controls to understand age-related differences in impairment.

What are the potential side effects?

While specific side effects are not listed for this trial, common side effects from cannabis may include altered senses, mood changes, impaired body movement, difficulty thinking and problem-solving, impaired memory, and an increased risk of accidents.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 19-25 or 35-45 years old.

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I am between 19-25 or 35-45 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not pregnant or breastfeeding.

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I have a mental health condition that makes cannabis use unsafe for me.

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A close family member has been diagnosed with schizophrenia or a similar condition.

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I regularly use medications that affect my brain function, including sedatives or psychoactive drugs.

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I do not have conditions like severe heart, lung, kidney, or liver diseases that make cannabis use unsafe for me.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ one hour after cannabis exposure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~one hour after cannabis exposure

This trial's timeline: 3 weeks for screening, Varies for treatment, and one hour after cannabis exposure for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Standard deviation of lateral position

Secondary study objectives

Blood concentration of 11-hydroxy-tetrahydrocannabinol (11-OH-THC)

Blood concentration of carboxy-tetrahydrocannabinol (THC-COOH)

Blood concentration of delta-9-tetrahydrocannabinol (THC)

+15 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Age group 35 to 45Experimental Treatment2 Interventions

Participants will complete two sessions: one where they drive the simulator before and after smoking a placebo cannabis cigarette (\<1% THC), the other where they drive the simulator before and after smoking an active cannabis cigarette (15% ± 5% THC).

Group II: Age group 19 to 25Experimental Treatment2 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Placebos

2019

Completed Phase 4

~2030

Cannabis

2014

Completed Phase 3