Overview

A Phase III, Randomized, Double-blind, Placebo-controlled Study to Confirm the AuthenTicity of Point of Care Urine samplEs Using Oral fluoreScein Sodium in adulTs With substancE Use Disorder

Status:
NOT_YET_RECRUITING

Trial end date:
2026-12-31

Target enrollment:

Participant gender:

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.

Phase:

PHASE3

Details

Lead Sponsor:

UpTru Inc.

Treatments:

Fluorescein