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Pharmacokinetic and Pharmacodynamic Effects of Passive Cannabis Inhalation

This study has been completed.
Sponsor:
Collaborators:
Substance Abuse and Mental Health Services Administration (SAMHSA)
RTI International
Information provided by (Responsible Party):
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01798186
First received: February 18, 2013
Last updated: August 2, 2017
Last verified: August 2017
  Purpose
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 Intervention Phase
Cannabis Toxicology Drug: Cannabis Phase 1

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • 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:
  • 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.

  • Subjective VAS Drug Effect [ Time Frame: immediately post cannabis exposure. ]
    Visual analog scale (0-100; not at all to extremely) of subjective "Drug Effect"


Enrollment: 26
Study Start Date: May 2013
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01798186

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     History of Changes
Other Study ID Numbers: NA_00082269
Study First Received: February 18, 2013
Results First Received: April 17, 2017
Last Updated: August 2, 2017

Additional relevant MeSH terms:
Marijuana Abuse
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 22, 2017