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NOT YET RECRUITING
NCT07356349
PHASE3

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

Sponsor: UpTru Inc.

View on ClinicalTrials.gov

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.

Official title: AuthenTicity of Point of Care Urine samplEs Using Oral fluoreScein Sodium in adulTs With substancE Use Disorder

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

114

Start Date

2026-01-15

Completion Date

2026-12-31

Last Updated

2026-01-23

Healthy Volunteers

No

Interventions

DRUG

Fluorescein

Oral ingestion of 100 mg of fluorescein in 250 ml of Gatorade tm

OTHER

placebo

Ingestion of 250 ml of Gatorade tm without fluorescein