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Oral Fluid, Plasma and Whole Pharmacokinetics and Stability Following Smoked Cannabis

2014-08-27 03:15:48 | BioPortfolio

Summary

Background:

- 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.

Objectives:

- 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.

Eligibility:

- 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.)

Design:

- 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.

Description

Background:

Smoking is the most common route of cannabis administration, yet the pharmacokinetic properties of cannabinoids in oral fluid following cannabis smoking have not been adequately characterized. Oral fluid is an important alternative matrix for monitoring in drug treatment, criminal justice, military and workplace settings, and for driving under the influence of drugs detection. Characterization of cannabinoid pharmacokinetics in oral fluid, correlations between oral fluid, whole blood and plasma concentrations, and relationships between biomarker concentrations and concurrent pharmacodynamic effects are critical for the appropriate interpretation of cannabinoid tests. Furthermore, of great practical significance, the short- and long-term stability of cannabinoid biomarkers, including glucuronide conjugates, in authentic whole blood, plasma, and oral fluid specimens following cannabis smoking is poorly defined. The only stability data available are from fortified samples, rather than authentic specimens. Our own cannabinoid pharmacokinetic data have been questioned by reviewers due to the lack of stability data. Few investigators have the ability to conduct controlled administration studies and analyze these complex biological matrices with highly sensitive and specific instrumentation.

Objectives:

(1) Characterize cannabinoid (Delta-9-tetrahydrocannabinol, [THC]; 11-hydroxy-THC, [11-OH-THC]; 11-nor-9-carboxy-THC, [THCCOOH]; and their Phase II conjugates) pharmacokinetics in whole blood, plasma, oral fluid and urine following a single smoked dose of cannabis. (2) Determine whole blood/oral fluid and plasma/oral fluid cannabinoid ratios in authentic specimens following controlled smoked cannabis (3) Correlate concentrations of THC and its metabolites in whole blood, plasma and oral fluid with impairment as determined through subjective assessments and neurocognitive tasks. (4) Determine stability over time of free and conjugated cannabinoids in authentic whole blood, plasma, oral fluid and urine from cannabis users following a single smoked dose of cannabis under various storage conditions.

Subject Population:

Up to 15 healthy cannabis users aged 18-45 with an average frequency of use of at least twice per month in the three months prior to study entry will be recruited for the study. Ten completers are required.

Experimental Design and Methods:

Participants smoke one standardized NIDA THC cigarette during a single visit. Serial blood and oral fluid collections, and assessment of neurocognitive, physiological and subjective effects are performed once prior to and multiple times after smoking.

Outcome Measures:

Primary outcome measures include THC and metabolite concentrations in whole blood, plasma, and oral fluid, stability of these concentrations over time, performance on neurocognitive tasks and subjective assessments

Study Design

Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Conditions

Cannabis Use

Intervention

Cannabis Cigarette

Location

National Institute on Drug Abuse, Biomedical Research Center (BRC)
Baltimore
Maryland
United States
21224

Status

Recruiting

Source

National Institutes of Health Clinical Center (CC)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:15:48-0400

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Medical and Biotech [MESH] Definitions

Compound isolated from Cannabis sativa extract.

A physiologically inactive constituent of Cannabis sativa L.

Inhaling and exhaling the smoke from CANNABIS.

A plant family of the order Urticales, subclass Hamamelidae, class Magnoliopsida. It is most notable for the members, Cannabis and Hops.

Compounds having the cannabinoid structure. They were originally extracted from Cannabis sativa L. The most pharmacologically active constituents are TETRAHYDROCANNABINOL; CANNABINOL; and CANNABIDIOL.

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