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Pharmacokinetic and Pharmacodynamic Effects of Passive Cannabis Inhalation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01798186
First Posted: February 25, 2013
Last Update Posted: August 3, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Substance Abuse and Mental Health Services Administration (SAMHSA)
RTI International
Information provided by (Responsible Party):
Johns Hopkins University
Results First Submitted: April 17, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Diagnostic
Condition: Cannabis Toxicology
Intervention: Drug: Cannabis

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants were randomized to 3 experimental sessions. Additionally, participants were recruited to smoke cannabis in order to generate the smoke that was passively inhaled by the experimental groups.

Reporting Groups
  Description
Cannabis 5% THC, no Ventilation passive exposure to 5% THC in an unventilated room
Cannabis 11% THC, no Ventilation passive exposure to 11% THC cannabis smoke in an unventilated room
Cannabis 11% THC, Ventilated passive exposure to 11% THC cannabis smoke in a room with active air ventilation
Active Smokers Participants that smoked cannabis

Participant Flow:   Overall Study
    Cannabis 5% THC, no Ventilation   Cannabis 11% THC, no Ventilation   Cannabis 11% THC, Ventilated   Active Smokers
STARTED   6   6   6   8 
COMPLETED   6   6   6   8 
NOT COMPLETED   0   0   0   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Cannabis 5% THC, no Vent passive exposure to 5% THC cannabis smoke, unventilated room
Cannabis 11% THC, no Vent passive exposure to 11% THC cannabis smoke, unventilated room
Cannabis 11% THC, Vent passive exposure to 11% THC cannabis smoke, ventilated room
Smokers cannabis smokers
Total Total of all reporting groups

Baseline Measures
   Cannabis 5% THC, no Vent   Cannabis 11% THC, no Vent   Cannabis 11% THC, Vent   Smokers   Total 
Overall Participants Analyzed 
[Units: Participants]
 6   6   6   8   26 
Age 
[Units: Years]
Mean (Standard Deviation)
 25  (3)   29  (9)   30  (8)   29  (6)   28  (7) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
         
Female      3  50.0%      3  50.0%      3  50.0%      3  37.5%      12  46.2% 
Male      3  50.0%      3  50.0%      3  50.0%      5  62.5%      14  53.8% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
         
Hispanic or Latino      0   0.0%      0   0.0%      2  33.3%      1  12.5%      3  11.5% 
Not Hispanic or Latino      6 100.0%      6 100.0%      4  66.7%      7  87.5%      23  88.5% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
         
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Asian      1  16.7%      0   0.0%      0   0.0%      0   0.0%      1   3.8% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Black or African American      2  33.3%      1  16.7%      0   0.0%      2  25.0%      5  19.2% 
White      3  50.0%      5  83.3%      5  83.3%      5  62.5%      18  69.2% 
More than one race      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      1  16.7%      1  12.5%      2   7.7% 
Region of Enrollment 
[Units: Participants]
         
United States   6   6   6   8   18 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   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 ]

2.  Secondary:   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 ]

3.  Secondary:   Subjective VAS Drug Effect   [ Time Frame: immediately post cannabis exposure. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Ryan Vandrey
Organization: Johns Hopkins University
phone: 410-550-4036
e-mail: rvandrey@jhmi.edu



Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01798186     History of Changes
Other Study ID Numbers: NA_00082269
First Submitted: February 18, 2013
First Posted: February 25, 2013
Results First Submitted: April 17, 2017
Results First Posted: August 3, 2017
Last Update Posted: August 3, 2017