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):
Ryan Vandrey, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01798186
First received: February 18, 2013
Last updated: December 3, 2013
Last verified: December 2013

February 18, 2013
December 3, 2013
May 2013
August 2013   (final data collection date for primary outcome measure)
delta-9-tetrahydrocanabinol (THC) Tmax [ Time Frame: Post-Cannabis Exposure ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01798186 on ClinicalTrials.gov Archive Site
Intoxication [ Time Frame: Post-Cannabis Exposure ] [ Designated as safety issue: No ]
Immediately after exposure to cannabis, participants will provide subjective ratings of intoxication using a 100mm visual analog scale
Same as current
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 active versus passive (second-hand) inhalation of cannabis smoke on toxicological analysis of "native" oral fluid (saliva) 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
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Cannabis Intoxication
  • Drug: Cannabis
    Cannabis cigarettes, each containing approximately one gram of cannabis, will be smoked during a 60-minute session.
    Other Name: Marijuana
  • Drug: Second-hand cannabis smoke
    See description of study arm
    Other Name: marijuana
  • Active Comparator: Cannabis
    Participants in this condition will self-administer cannabis cigarettes ad libitum
    Intervention: Drug: Second-hand cannabis smoke
  • Experimental: Second-hand cannabis smoke
    Participants will be in a room with other participants who will be smoking cannabis. This group will be passively exposed to second-hand cannabis smoke.
    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
38
August 2013
August 2013   (final data collection date for primary outcome measure)

Participants must:

  1. Be between the ages of 18 and 45
  2. Be in good general health based on a physical examination, medical history, vital signs, 12-lead ECG and screening urine and blood tests
  3. Demonstrate ability to expectorate 3-5 mL of "native" oral fluid over a 5-minute period
  4. 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
  5. 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.
  6. Have a body mass index (BMI) in the range of 19 to 33 kg/m2
  7. Have head hair that is at least 4-6 cm (approximately two inches) in length on the back of the head.
  8. 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
  9. 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.
  10. 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.
  11. No history of panic/anxiety reaction to extended periods of confinement in close quarters, smoke filled areas, or tight social situations.
  12. No history of adverse reactions to cannabis exposure, whether via direct use or passive exposure.
Both
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01798186
NA_00082269
No
Ryan Vandrey, Johns Hopkins University
Ryan Vandrey
  • Substance Abuse and Mental Health Services Administration (SAMHSA)
  • RTI International
Not Provided
Johns Hopkins University
December 2013

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