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

Starting soon · Phase 3 · Has a placebo group

Conditions studied: Substance Use Disorder (SUD)

In brief

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.

Key facts

Study ID

NCT07356349

Run by

UpTru Inc.

People needed

114

Starts

2026-01-15

Expected to finish

2026-12-31

Last updated by the study team

2026-01-23

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• • Written informed consent, obtained from the person or legally acceptable representative, before any study-related procedure is performed. Adults aged between 18 and 65 years, inclusive, at the time of signing the informed consent form.
• A documented current substance use disorder, including but not limited to alcohol, cocaine, and/or opioid.
• Female participants must be: Not women of childbearing potential (WOCBP), i.e., postmenopausal and/or surgically sterile, OR: WOCBP who agree to use a contraceptive method that is highly effective (based on the investigator's judgment) for 28 days before and after study product administration.
• Male participants must agree to use effective birth control methods and must not donate sperm until 2 weeks after study product administration.
• Must agree not to be a gamete donor from Screening until 28 days after the follow-up telephone call.
• Willing and able to comply with the study instructions and attend all scheduled study visits.

You may not qualify if…

• Life expectancy less than 5 years.
• Women who are pregnant or are breast-feeding.
• Known cirrhosis.
• Diagnosis of Gilbert's syndrome.
• Heart failure, classified as being in New York Heart Association Class II-IV at Screening.
• Known allergy to fluorescein, Gatorade™, or any of their excipients.
• Estimated glomerular filtration rate <30 mL/min/1.73m2 using the Cockroft-Gault method at Screening.
• Hemoglobin <120 g/L at Screening.
• Diagnosis of sickle cell anemia or sickle cell trait.
• Any major episode of infection requiring hospitalization and/or treatment with intravenous antiinfective agents during the 2 months prior to Screening.
• Use of fluorescein for medical imaging (eg, angiogram, corneal staining) in the 3 days prior to the Randomization Visit. UP
• In the opinion of the investigator, any other condition that would preclude participation in the study.

Full record on ClinicalTrials.gov

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