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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
February 18, 2013
August 2, 2017
May 2013
August 2013   (Final data collection date for primary outcome measure)
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.
delta-9-tetrahydrocanabinol (THC) Tmax [ Time Frame: Post-Cannabis Exposure ]
After exposure to cannabis, we will conduct a pharmacokinetic analysis of THC in saliva and 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.
Complete list of historical versions of study NCT01798186 on ClinicalTrials.gov Archive Site
  • 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"
Intoxication [ Time Frame: Post-Cannabis Exposure ]
Immediately after exposure to cannabis, participants will provide subjective ratings of intoxication using a 100mm visual analog scale
Not Provided
Not Provided
 
Pharmacokinetic and Pharmacodynamic Effects of Passive Cannabis Inhalation
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.
Not Provided
Interventional
Phase 1
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
Cannabis Toxicology
Drug: Cannabis
Participants will be exposed to cannabis smoke present in ambient air
Other Name: Marijuana
  • 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.
    Intervention: Drug: Cannabis
  • 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.
    Intervention: Drug: Cannabis
  • 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.
    Intervention: Drug: Cannabis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
26
August 2013
August 2013   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 45 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01798186
NA_00082269
No
Not Provided
Not Provided
Johns Hopkins University
Johns Hopkins University
  • Substance Abuse and Mental Health Services Administration (SAMHSA)
  • RTI International
Not Provided
Johns Hopkins University
August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP