Clinical Trial

Study to Confirm the AuthenTicity of Point of Care Urine samplEs Using Oral fluoreScein Sodium in adulTs With substancE Use Disorder (ATTESTED)

Study acronym: ATTESTED
Not Yet Recruiting Phase 3
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Summary
The purpose of this phase III, randomized, double-blind, placebo-controlled study is to confirm the authenticity of point-of-care urine samples in adult persons with substance use disorder using fluorescein sodium as a marker. Eligible persons will, drink a sample of Gatorade™ which includes either, 100 mg fluorescein sodium, or not, followed by 500 mL of water. Fifteen minutes after consuming the Gatorade™, participants will provide a mid-stream urine sample (at least 10 mL urine is required) for examination of fluorescence (in a single-blinded manner) using a Qubit™ fluorometer.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2026-01-12.
Trial Details
NCT Number NCT07356349
Lead Sponsor UpTru Inc.
Conditions Substance Use Disorder (SUD)
Enrollment 114 participants
Start Date 2026-01-15
Primary Completion 2026-09-30 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-01-23