Pharmacokinetic and Pharmacodynamic Effects of Passive Cannabis Inhalation



Status:Completed
Conditions:Psychiatric
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - 45
Updated:8/4/2017
Start Date:May 2013
End Date:August 2013

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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.


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.
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