Pharmacokinetic and Pharmacodynamic Effects of Passive Cannabis Inhalation

• ClinicalTrials.gov Identifier: NCT01798186
• Recruitment Status: Completed
• First Posted: February 25, 2013
• Results First Posted: August 3, 2017
• Last Update Posted: August 3, 2017
• Sponsor: Johns Hopkins University
• Collaborators: Substance Abuse and Mental Health Services Administration (SAMHSA); RTI International
• Information provided by (Responsible Party): Johns Hopkins University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Cannabis Toxicology	Drug: Cannabis	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 26 participants
• 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
• Primary Purpose: Diagnostic
• Official Title: Pharmacokinetic and Pharmacodynamic Effects of Passive Cannabis Inhalation
• Study Start Date: May 2013
• Actual Primary Completion Date: August 2013
• Actual Study Completion Date: August 2013

Arms and Interventions

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 Name: 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 Name: 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 Name: Marijuana

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

1. Delta-9-tetrahydrocannabinol (THC) Cmax in Oral Fluid [ Time Frame: 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 ]
   After exposure to cannabis, we will conduct a pharmacokinetic analysis of THC in oral fluid.
2. Subjective VAS Drug Effect [ Time Frame: immediately post cannabis exposure. ]
   Visual analog scale (0-100; not at all to extremely) of subjective "Drug Effect"

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 45 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

United States, Maryland

Johns Hopkins Behavioral Pharmacology Research Unit

Baltimore, Maryland, United States, 21224

Sponsors and Collaborators

Johns Hopkins University

Substance Abuse and Mental Health Services Administration (SAMHSA)

RTI International

More Information

• Responsible Party: Johns Hopkins University
• ClinicalTrials.gov Identifier: NCT01798186
• Other Study ID Numbers: NA_00082269
• First Posted: February 25, 2013
• Results First Posted: August 3, 2017
• Last Update Posted: August 3, 2017
• Last Verified: August 2017

Additional relevant MeSH terms:

Marijuana Abuse; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders