Differences in Cannabis Impairment and Its Measurement Due to Route of Administration

Study Overview
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Brief Summary
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This research is being done to measure the effects of both oral and vaporized cannabis (marijuana), at different doses, on the ability to perform certain tasks such as balancing, eye tracking, and computerized measures of memory and attention, as well as performance on a novel app (DRUID) that is being developed for field sobriety testing. The investigators will collect biological fluids (urine, blood, saliva/spit) after cannabis is eaten or vaporized to see if there are markers in those fluids that can predict performance on the behavioral tasks and the DRUID App. The results of this study will help us better understand the effects of using cannabis, and to help identify behaviors and/or substances in the body that relate to cannabis impairment.

Official Title
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Differences in Cannabis Impairment and Its Measurement Due to Route of Administration

Conditions
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Behavioral Pharmacology of Cannabis

Intervention / Treatment
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* Drug: cannabis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Be in good general health based on a physical examination, medical history, vital signs, 12-lead ECG and screening urine and blood tests Test negative for recent cannabis use in urine at the screening visit (confirmed by Gas Chromatography (GC)/ Mass Spectrometry (MS) laboratory test) and at clinic admission Test negative for other drugs of abuse, including alcohol at the screening visit and at clinic admission Demonstrate ability to expectorate 3-5 mL of native oral fluid over a 5-minute period Not be pregnant or nursing (if female). All females must have a negative serum pregnancy test at the screening visit and a negative urine pregnancy test at clinic admission. Have a body mass index (BMI) in the range of 19 to 36 kg/m2 Blood pressure at Screening Visit does not exceed a systolic blood pressure (SBP) of 150 mmHg or a diastolic blood pressure (DBP) of 90 mmHg Have no allergies to any of the ingredients used to prepare cannabis brownies (chocolate, eggs, wheat, etc.). Report prior experience inhaling cannabis (either via smoking or vaporization). Exclusion Criteria: History of or current evidence of significant medical or psychiatric illness judged by the investigator to put the participant at greater risk of experiencing an adverse event due to exposure or completion of other study procedures. Use of an Over-the-Counter (OTC), systemic or topical drug(s), herbal supplement(s), or vitamin(s) within 14 days of experimental sessions; which, in the opinion of the investigator or sponsor, will interfere with the study result or the safety of the subject. Use of a prescription medication (with the exception of birth control prescriptions) within 14 days of experimental sessions; which, in the opinion of the investigator or sponsor, will interfere with the study result or the safety of the subject. Use of hemp seeds or hemp oil in any form in the past 3 months. Use of dronabinol (Marinol) within the past 6 months. History of xerostomia (dry mouth), or the presence of mucositis, gum infection or bleeding, or other significant oral cavity disease or disorder that in the investigator's opinion may affect the collection of oral fluid samples. History of clinically significant cardiac arrhythmias or vasospastic disease (e.g., Prinzmetal's angina). Abnormal EKG result that in the investigator's opinion is clinically significant. Epilepsy or a history of seizures. Enrolled in another clinical trial or have received any drug as part of a research study within 30 days prior to dosing

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo Oral Cannabis<br>Single acute administration of placebo cannabis baked into a brownie | Drug: cannabis<br>* Cannabis will be self-administered by study participants<br>* Other names: marijuana;|
| Experimental: Low-Dose Oral Cannabis<br>Single acute administration of cannabis containing 10mg THC baked into a brownie | Drug: cannabis<br>* Cannabis will be self-administered by study participants<br>* Other names: marijuana;|
| Experimental: High-Dose Oral Cannabis<br>Single acute administration of cannabis containing 25mg THC baked into a brownie | Drug: cannabis<br>* Cannabis will be self-administered by study participants<br>* Other names: marijuana;|
| Placebo Comparator: Placebo Vaporized Cannabis<br>Single acute administration of placebo cannabis via commercial vaporizer | Drug: cannabis<br>* Cannabis will be self-administered by study participants<br>* Other names: marijuana;|
| Experimental: Low-Dose Vaporized Cannabis<br>Single acute administration of placebo cannabis containing 5mg THC via commercial vaporizer | Drug: cannabis<br>* Cannabis will be self-administered by study participants<br>* Other names: marijuana;|
| Experimental: High-Dose Vaporized Cannabis<br>Single acute administration of placebo cannabis containing 20mg THC via commercial vaporizer | Drug: cannabis<br>* Cannabis will be self-administered by study participants<br>* Other names: marijuana;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tetrahydrocannabinol (THC) Concentration in Blood | Quantitation of active drug (THC) in whole blood (ng/ml). | 8 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 11-hydroxy-tetrahydrocannabinol (11-OH-THC) | Quantitation of THC metabolite in blood (ng/ml) | 8 hours | 
| Tetrahydrocannabinolic Acid (THCCOOH) | Quantitation of THC metabolite in blood (ng/ml). | 8 hours | 
| Change in Heart Rate | Peak change from baseline | Baseline, 1, 2, 3, 4, 5, 6, 7, and 8 hours post drug exposure | 
| Mean (SD) Peak Change-from-baseline Drug Effect Rating | Subjective rating of drug effect (0-100) at peak effect: between 2 and 5 hours for oral dosing conditions and 0 and 2 hours for vaporized conditions. Higher numbers mean stronger drug effects, where 0 means no drug effect and 100 means extremely strong drug effect. | Up to 5 hours | 
| Change From Baseline Behavioral Task Performance as Assessed by the DRUID App Score | Composite Global Impairment Score on the DRUID (DRiving Under the Influence of Drugs) App, a measure of behavioral task performance (range 0-100) where lower scores indicate better performance. ≥13-point change (from baseline) on DRUID global impairment score = impaired; <13-point change (from baseline) = not impaired. | 8 hours | 
| Peak Change in Blood Pressure | Systolic and Diastolic blood pressure will be measured at baseline and repeatedly for 8 hours after drug exposure. Outcome is the peak change from baseline assessed within the 8 hour period of assessment. | 8 hours post drug exposure |