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
  Purpose

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.


Condition Intervention Phase
Cannabis Intoxication
Drug: Cannabis
Drug: Second-hand cannabis smoke
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
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-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.


Secondary Outcome Measures:
  • 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


Enrollment: 38
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
Active Comparator: Cannabis
Participants in this condition will self-administer cannabis cigarettes ad libitum
Drug: Second-hand cannabis smoke
See description of study arm
Other Name: marijuana
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.
Drug: Cannabis
Cannabis cigarettes, each containing approximately one gram of cannabis, will be smoked during a 60-minute session.
Other Name: Marijuana

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  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
Ryan Vandrey
Substance Abuse and Mental Health Services Administration (SAMHSA)
RTI International
  More Information

No publications provided

Responsible Party: Ryan Vandrey, Assistant Professor, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01798186     History of Changes
Other Study ID Numbers: NA_00082269
Study First Received: February 18, 2013
Last Updated: December 3, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 18, 2014