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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo Cannabis Edibles (0 mg THC) | Experimental | Participants consume a placebo dose of cannabis edibles (0 mg THC). |
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| Low Dose Cannabis Edibles (2 mg THC) | Experimental | Participants consume a low dose of cannabis edibles (2 mg THC). |
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| Medium Dose Cannabis Edibles (10 mg) | Experimental | Participants consume a medium dose of cannabis edibles (10 mg THC). |
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| High Dose Cannabis Edibles (20 mg) | Experimental | Participants consume a high dose of cannabis edibles (20 mg THC). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cannabis - Placebo Dose (0 mg) | Drug | Participants will consume placebo cannabis edibles. |
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| Measure | Description | Time Frame |
|---|---|---|
| Standard Deviation of Lateral Position (SDLP) | The driving simulator will objectively record SDLP during a number of pre-programmed driving scenarios. | Before cannabis exposure; 2 and 5 hours after cannabis exposure (repeated each session for 4 sessions). Also repeated on the test for residual effects, approximately 24 hours after dosing. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Speed (MS) | The driving simulator will objectively record MS during a number of pre-programmed driving scenarios. | Before cannabis exposure; 2 and 5 hours after cannabis exposure (repeated each session for 4 sessions). Also repeated on the test for residual effects, approximately 24 hours after dosing. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bernard Le Foll, MD, PhD | Centre for Addiction and Mental Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Addiction and Mental Health | Toronto | Ontario | M5S 2S1 | Canada |
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| ID | Term |
|---|---|
| D002189 | Marijuana Abuse |
| D000066448 | Driving Under the Influence |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D000066479 | Criminal Behavior |
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| ID | Term |
|---|---|
| C587251 | nabiximols |
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The study will be a within-subjects, double-blind, placebo-controlled, randomized and counterbalanced human laboratory experiment assessing the effects of a range of doses of cannabis edibles on driving simulator performance. These 4 drug exposure conditions are: placebo, low dose (2 + 2% mg THC), medium dose (10 + 2% mg THC), and high dose (20 + 2% mg THC).
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| Cannabis - Low Dose (2 mg) | Drug | Participants will consume a low dose (2 mg) of cannabis edibles. |
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| Cannabis - Medium Dose (10 mg) | Drug | Participants will consume a medium dose (10 mg) of cannabis edibles. |
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| Cannabis - High Dose (20 mg) | Drug | Participants will consume a high dose (20 mg) of cannabis edibles. |
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| Reaction Time (RT) |
The driving simulator will objectively record RT during a number of pre-programmed driving scenarios. |
| Before cannabis exposure; 2 and 5 hours after cannabis exposure (repeated each session for 4 sessions). Also repeated on the test for residual effects, approximately 24 hours after dosing. |
| Standard Deviation of Speed (SDS) | The driving simulator will objectively record SDS during a number of pre-programmed driving scenarios. | Before cannabis exposure; 2 and 5 hours after cannabis exposure (repeated each session for 4 sessions). Also repeated on the test for residual effects, approximately 24 hours after dosing. |
| Blood concentrations of Δ9-tetrahydrocannabinol (THC), 11-hydroxy-Δ9-tetrahydrocannabinol (OH-THC), and 11-Nor-9-carboxy-Δ9-tetrahydrocannabinol (THC-COOH) | Used to assess THC and metabolite concentrations (ng/mL) in blood. | Before cannabis exposure; 2 and 5 hours after cannabis exposure (repeated each session for 4 sessions). Also repeated on the test for residual effects, approximately 24 hours after dosing. |
| Oral fluid concentrations of Δ9-tetrahydrocannabinol (THC), 11-hydroxy-Δ9-tetrahydrocannabinol (OH-THC), and 11-Nor-9-carboxy-Δ9-tetrahydrocannabinol (THC-COOH) and point-of-care detection of cannabinoids | Used to assess THC and metabolite concentrations (ng/mL) in oral fluid. | Before cannabis exposure; 2 and 5 hours after cannabis exposure (repeated each session for 4 sessions). Also repeated on the test for residual effects, approximately 24 hours after dosing. |
| Heart Rate | Heart rate (bpm) will be measured. | Before cannabis exposure; 0, 30, 60, 90 minutes and 2, 3, 4 and 5 hours after cannabis exposure (repeated each session for 4 sessions). Also repeated approximately 24 hours after dosing. |
| Blood Pressure | Systolic and diastolic blood pressure (mmHg) will be measured. | Before cannabis exposure; 0, 30, 60, 90 minutes and 2, 3, 4 and 5 hours after cannabis exposure (repeated each session for 4 sessions). Also repeated approximately 24 hours after dosing. |
| Temperature | Temperature (degrees Celsius) will be measured. | Before cannabis exposure; 0, 30, 60, 90 minutes and 2, 3, 4 and 5 hours after cannabis exposure (repeated each session for 4 sessions). Also repeated approximately 24 hours after dosing. |
| Visual Analog Scale (VAS) | Used to assess subjective effects of cannabis on a sliding scale of 0 (not at all) to 100 (maximum effect). | Before cannabis exposure; 0, 30, 60, 90 minutes and 2, 3, 4 and 5 hours after cannabis exposure (repeated each session for 4 sessions). Also repeated approximately 24 hours after dosing. |
| Addiction Research Centre Inventory (ARCI) | Used to assess subjective effects of cannabis. | Before cannabis exposure; 2 and 5 hours after cannabis exposure (repeated each session for 4 sessions). Also repeated on the test for residual effects, approximately 24 hours after dosing. |
| Profile of Mood States (POMS) | Used to assess subjective effects of cannabis. | Before cannabis exposure; 2 and 5 hours after cannabis exposure (repeated each session for 4 sessions). Also repeated on the test for residual effects, approximately 24 hours after dosing. |
| Verbal Free Recall Task | Used to assess the impact of cannabis on verbal learning and memory. | Before cannabis exposure; 2 and 5 hours after cannabis exposure (repeated each session for 4 sessions). Also repeated on the test for residual effects, approximately 24 hours after dosing. |
| Blood Concentrations of mtDNA | Used to assess concentrations of mtDNA. | Before cannabis exposure; 2 and 5 hours after cannabis exposure (repeated each session for 4 sessions). Also repeated on the test for residual effects, approximately 24 hours after dosing. |
| Blood Concentrations Endocannabinoids | Used to assess concentrations of endocannabinoids. | Before cannabis exposure; 2 and 5 hours after cannabis exposure (repeated each session for 4 sessions). Also repeated on the test for residual effects, approximately 24 hours after dosing. |
| D001519 | Behavior |
| D003617 | Dangerous Behavior |