Pharmacokinetic and Pharmacodynamic Effects of Passive Cannabis Inhalation

Study Overview
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Brief Summary
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This primary aim of this study is to assess the effects of passive (second-hand) inhalation of cannabis smoke on toxicological analysis of native oral fluid (saliva), urine and blood specimens. The results of this study will help inform the validity of oral fluid as a biomarker of cannabis exposure and to determine whether, and for how long, passive inhalation of cannabis smoke could result in a positive toxicology result.

Official Title
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Pharmacokinetic and Pharmacodynamic Effects of Passive Cannabis Inhalation

Conditions
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Cannabis Toxicology

Intervention / Treatment
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* Drug: Cannabis


Participation Criteria
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Eligibility Criteria
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Participants must: Be between the ages of 18 and 45 Be in good general health based on a physical examination, medical history, vital signs, 12-lead ECG and screening urine and blood tests Demonstrate ability to expectorate 3-5 mL of native oral fluid over a 5-minute period Be willing and able to abstain from use of any over-the-counter (OTC) or prescription drugs (other than birth control medications) after providing written informed consent and continuing until discharged from the study. OTC antacids may be taken up to 12 hours prior to dosing Not be pregnant or nursing (if female), and using effective birth control. 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 33 kg/m2 Have head hair that is at least 4-6 cm (approximately two inches) in length on the back of the head. Blood pressure at Screening Visit must not exceed a systolic blood pressure (SBP) of 140 mmHg or a diastolic blood pressure (DBP) of 90 mmHg Must not have history 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. Cannot have been enrolled in another clinical trial or have received any drug as part of a research study within 30 days prior to dosing. No history of panic/anxiety reaction to extended periods of confinement in close quarters, smoke filled areas, or tight social situations. No history of adverse reactions to cannabis exposure, whether via direct use or passive exposure.

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: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Between subjects Phase I study
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cannabis 5% THC, No Ventilation<br>Participants in this condition will be passively exposed to second-hand cannabis smoke from cannabis containing 5% THC and in a room with no ventilation. | Drug: Cannabis<br>* Participants will be exposed to cannabis smoke present in ambient air<br>* Other names: Marijuana;|
| Experimental: Cannabis 11% THC, No Ventilation<br>Participants in this condition will be passively exposed to second-hand cannabis smoke from cannabis containing 11% THC and in a room with no ventilation. | Drug: Cannabis<br>* Participants will be exposed to cannabis smoke present in ambient air<br>* Other names: Marijuana;|
| Experimental: Cannabis 11% THC, Ventilation<br>Participants in this condition will be passively exposed to second-hand cannabis smoke from cannabis containing 11% THC in a room with active ventilation. | Drug: Cannabis<br>* Participants will be exposed to cannabis smoke present in ambient air<br>* Other names: Marijuana;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Delta-9-tetrahydrocannabinol (THC) Cmax in Blood | After exposure to cannabis, we will conduct a pharmacokinetic analysis of THC in blood collected. | 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 22, 26, 30, and 34 hours post cannabis exposure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Delta-9-tetrahydrocannabinol (THC) Cmax in Oral Fluid | After exposure to cannabis, we will conduct a pharmacokinetic analysis of THC in oral fluid. | Samples collected 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 22, 26, 30, and 34 hours post cannabis exposure | 
| Subjective VAS Drug Effect | Visual analog scale (0-100; not at all to extremely) of subjective Drug Effect | immediately post cannabis exposure. |