Pharmacokinetic and Pharmacodynamic Effects of Passive Cannabis Inhalation

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.

Study Overview

• Status: Completed
• Conditions: Cannabis Toxicology
• Intervention / Treatment: Drug: Cannabis

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21224
      • Johns Hopkins Behavioral Pharmacology Research Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Cannabis 5% THC, No Ventilation; 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; Participants will be exposed to cannabis smoke present in ambient air; Other Names: Marijuana
EXPERIMENTAL: Cannabis 11% THC, No Ventilation; 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; Participants will be exposed to cannabis smoke present in ambient air; Other Names: Marijuana
EXPERIMENTAL: Cannabis 11% THC, Ventilation; 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; Participants will be exposed to cannabis smoke present in ambient air; Other Names: Marijuana

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: RTI International; Substance Abuse and Mental Health Services Administration (SAMHSA)

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (ACTUAL): August 1, 2013
• Study Completion (ACTUAL): August 1, 2013

Study Registration Dates

• First Submitted: February 18, 2013
• First Submitted That Met QC Criteria: February 21, 2013
• First Posted (ESTIMATE): February 25, 2013

Study Record Updates

• Last Update Posted (ACTUAL): August 3, 2017
• Last Update Submitted That Met QC Criteria: August 2, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Marijuana Abuse
• Other Study ID Numbers: NA_00082269