drugset / Trial / NCT07356349

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

NCT07356349

Phase 3 Not yet recruiting 114 enrolled UpTru Inc.
RandomizedParallel-groupTriple-blindDiagnostic

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.

Timeline

Start
2026-01-15
Primary completion
2026-09-30
Completion
2026-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Fluorescein Diagnostic / imaging agent 100 mg Oral