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NCT01071616 · ClinicalTrials.gov registry record · Phase 1
Oral Fluid, Plasma and Whole Pharmacokinetics and Stability Following Smoked Cannabis
A Phase 1 study, sponsored by National Institute on Drug Abuse (NIDA).
- Completed
- Registry status
- Phase 1
- Development phase
- 45
- Enrollment target
NCT01071616 is a Phase 1 study that has completed, run by National Institute on Drug Abuse (NIDA). The registered enrollment target is 45 participants.
The verdict
NCT01071616, a Phase 1 study, has completed, sponsored by National Institute on Drug Abuse (NIDA).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 45 participants
- Enrollment target
Study 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
Interventions
- DRUG Cannabis Cigarette
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2010-01-22 |
| Est. Completion | 2013-11-29 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01071616
The ClinicalTrials.gov registry entry for NCT01071616 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 45 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute on Drug Abuse (NIDA), which has 335 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Cannabis Cigarette is the first listed.
NCT01071616 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01071616 about?
NCT01071616 is a clinical study titled "Oral Fluid, Plasma and Whole Pharmacokinetics and Stability Following Smoked Cannabis". 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...
What is the current status of trial NCT01071616?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 45 participants. The study started on 2010-01-22. Estimated completion is 2013-11-29.
What interventions are being tested in trial NCT01071616?
The interventions under investigation include: Cannabis Cigarette (DRUG).
Who is sponsoring clinical trial NCT01071616?
This trial is sponsored by National Institute on Drug Abuse (NIDA), which has 335 total clinical trials registered on ClinicalTrials.gov.
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