Urine Sample Authenticity Clinical Trial
Official title:
A Phase I, Randomized, Double-blind, Placebo-controlled Study of Oral Fluorescite to Confirm the Authenticity of Point of Care Urine Samples
During this study, participants will ingest 100 mg of fluorescein disodium or a placebo (no drug) mixed in GatoradeTM. Participants will then provide a urine sample after 10, 15, 20 or 30 minutes to see if the investigator can detect fluorescein fluorescence (light) in the urine.
Every year, millions of dollars are spent on urine drug testing. Urine samples are generally
provided in an unwitnessed fashion. Only a small percentage of samples involve direct
observation of urination. The authenticity of the provided sample greatly affects its
clinical utility and/or the validity of the test results. Direct observation of urination can
be unpleasant and humiliating for people. For the institution, there are increased costs (for
example, staff, insurance) and risks regarding impropriety when direct observation is
utilized.
Participants are being asked to take part in a research study of an approved drug called
FluoresciteTM. FluoresciteTM is an intravenous drug (administered into a vein) that has been
approved by Health Canada. The active ingredient in FluoresciteTM is fluorescein disodium
(10% fluorescein disodium in sterile water).
Fluorescein disodium has been used medically for over fifty years. It is a fluorophore (emits
light, similar to a yellow glowstick) that is most commonly used in ophthalmology (the study
and treatment of disorders and diseases of the eye). It is currently used in angiography (to
view blood vessels), or topically for staining the eye's cornea. FluoresciteTM or fluorescein
disodium has not been approved by Health Canada for oral administration.
During this study, participants will ingest 100 mg of fluorescein disodium or a placebo (no
drug) mixed in GatoradeTM. The Investigator will then ask the participant to provide a urine
sample after 10, 15, 20 or 30 minutes to see if he can detect fluorescence (light) in the
urine.
The purpose of this study is to:
- Develop a new standardized protocol for urine sampling that will increase sample
authenticity and make the situation between the patient/physician more pleasant.
- To evaluate the safety and tolerability of orally ingested fluorescein disodium.
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