NCT07356349

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

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

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 114 (estimated)
• Sponsor: UpTru Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

One hundred fourteen eligible persons will be randomized. One hour after completely emptying their bladders, in a blinded manner, half will receive Gatorade and the other half will receive Gatorade with 100 mg of fluorescein. All will then drink 500 ml of water and 15 minutes later they will provide urine samples. A solution of sodium bicarbonate will be added to the samples and blinded observers will then examine all of the samples for fluorescence using a Qbit fluorometer.

Conditions

• Substance Use Disorder (SUD)

Interventions

Type	Name	Description
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

Timeline

• Start date: 2026-01-15
• Primary completion: 2026-09-30
• Completion: 2026-12-31
• First posted: 2026-01-21
• Last updated: 2026-01-23