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Clinical Trials/NCT07356349
NCT07356349Not yet recruitingPhase 3

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

UpTru Inc.0 sites114 target enrollmentStarted: January 15, 2026Last updated:
Interventions

Trial Snapshot

Phase
Phase 3
Status
Not yet recruiting
Sponsor
Enrollment
114
Primary Endpoint
Detection

Study Overview

Brief 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Diagnostic
Masking
Triple (Participant, Care Provider, Investigator)

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • • 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.

Exclusion Criteria

  • 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.

Arms & Interventions

Fluorescein

Experimental

Ingestion of 100 mg of fluorescein with 250 ml Gatorade tm

Intervention: Fluorescein (Drug)

placebo

Placebo Comparator

ingestion of 250 ml Gatorade tm without fluorescein

Intervention: placebo (Other)

Outcomes

Primary Outcomes

Detection

Time Frame: 15 minutes post ingestion

Presence of fluorescence

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
UpTru Inc.
Sponsor Class
Industry
Responsible Party
Sponsor

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