Oral Fluid, Plasma and Whole Pharmacokinetics and Stability Following Smoked Cannabis
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|ClinicalTrials.gov Identifier: NCT01071616|
Recruitment Status : Completed
First Posted : February 19, 2010
Last Update Posted : July 5, 2018
- Little research has been done on how different components of cannabis (marijuana) appear in oral fluid (i.e., saliva) after smoking. Cannabinoids have been well studied in whole blood, plasma, and urine after cannabis use, but less is known about how cannabinoids appear in oral fluid after controlled drug administration and how long these biomarkers last after use. In addition, the issue of stability of cannabinoids and their glucuronide metabolites is a controversial topic that is poorly understood. These data are critical to the interpretation of cannabinoid test results.
- To collect whole blood, plasma, urine, and oral fluid specimens after smoking cannabis, to characterize the disposition and pharmacokinetics of cannabinoids in multiple biological matrices and to provide scientifically reliable data on the stability of cannabinoids and metabolites.
- To test basic brain function and thinking processes after smoking cannabis.
- Healthy volunteers between 18 and 45 years of age who use cannabis (an average of at least twice per month in the 3 months before the study.)
- Participants may complete the single study session as outpatients, or they may spend the night prior to and/or following drug administration at the residential research unit in Baltimore, MD. Participants must provide a negative urine drug screen if they have not spent the evening prior to testing at the research unit.
- Participants will provide whole blood, plasma, oral fluid, and urine samples, and will complete several tests of thinking and brain function at the start of the study.
- Participants will smoke one standardized cannabis cigarette. Blood and oral fluid samples will be collected, and participants will repeat the tests of thinking and brain function multiple times after smoking.
- Six hours after smoking the cigarette, participants must pass a neuromotor exam (testing balance and coordination) before they can be discharged from the study. Participants may be asked to stay overnight at the clinical center if there are concerns for their safety because of intoxication.
|Condition or disease||Intervention/treatment||Phase|
|Cannabis Use Drug Abuse||Drug: Cannabis Cigarette||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||45 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Oral Fluid, Plasma and Whole Pharmacokinetics and Stability Following Smoked Cannabis|
|Study Start Date :||January 22, 2010|
|Actual Study Completion Date :||November 29, 2013|
- THC and metabolite concentrations in whole blood, plasma, and oral fluid, stability of these concentrations over time, performance on neurocognitive tasks and subjective assessments.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01071616
|United States, Maryland|
|National Institute on Drug Abuse, Biomedical Research Center (BRC)|
|Baltimore, Maryland, United States, 21224|
|Principal Investigator:||Marilyn Huestis, Ph.D.||National Institute on Drug Abuse (NIDA)|