Clinical trial NCT01798186: Pharmacokinetic and Pharmacodynamic Effects of Passive Cannabis Inhalation
Official title: Pharmacokinetic and Pharmacodynamic Effects of Passive Cannabis Inhalation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cannabis Toxicology
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Substance Abuse and Mental Health Services Administration (SAMHSA)
name: RTI International
First posted: 2013-02-25
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Between subjects Phase I study
Primary purpose: DIAGNOSTIC

Brief 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.

Primary outcomes:
measure: Delta-9-tetrahydrocannabinol (THC) Cmax in Blood
timeFrame: 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 outcomes:
measure: Delta-9-tetrahydrocannabinol (THC) Cmax in Oral Fluid
timeFrame: 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
measure: Subjective VAS Drug Effect
timeFrame: immediately post cannabis exposure.
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Behavioral Pharmacology Research Unit
state: Maryland
Study officials:
References: