Pharmacokinetic and Pharmacodynamic Effects of Passive Cannabis Inhalation
Condition: Cannabis Toxicology
MeSH terms: Marijuana Abuse
Intervention: Cannabis
Intervention description: Participants will be exposed to cannabis smoke present in ambient air
Phase: Phase 1
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Between subjects Phase I study
Masking: Single (Participant)
Masking description: Participants are blind to the THC concentrations of cannabis being administered
Enrollment: 26.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      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.
    

Eligibility criteria:

        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.