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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Substance Use Disorder (SUD)
• Intervention / Treatment: Drug: Fluorescein; Other: placebo

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 Type: Interventional
• Enrollment (Estimated): 114
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Mark Dubé R President UPTru inc., MD; Phone Number: 1 7055222263; Email: mark.dube@upreu.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fluorescein; Ingestion of 100 mg of fluorescein with 250 ml Gatorade tm	Drug: Fluorescein; Oral ingestion of 100 mg of fluorescein in 250 ml of Gatorade tm; Other Names: Experimental: Fluorescein
Placebo Comparator: placebo; ingestion of 250 ml Gatorade tm without fluorescein	Other: placebo; Ingestion of 250 ml of Gatorade tm without fluorescein

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Detection	Presence of fluorescence	15 minutes post ingestion
Detection	Presence of fluorescence .30,000 using fluorometer	15 minutes post ingestion

Collaborators and Investigators

• Sponsor: UpTru Inc.

Publications and helpful links

Helpful Links

• Sponsor's Home Page
• Related Info

Study record dates

Study Major Dates

• Study Start (Estimated): January 15, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: January 12, 2026
• First Submitted That Met QC Criteria: January 12, 2026
• First Posted (Actual): January 21, 2026

Study Record Updates

• Last Update Posted (Actual): January 23, 2026
• Last Update Submitted That Met QC Criteria: January 21, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: randomized controlled trial; substitution heuristic
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Organic Chemicals; Heterocyclic Compounds; Heterocyclic Compounds, Fused-Ring; Hydrocarbons; Hydrocarbons, Cyclic; Polycyclic Compounds; Heterocyclic Compounds, 3-Ring; Spiro Compounds; Fluoresceins; Xanthenes; Fluorescein
• Other Study ID Numbers: UPTRu-301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: raw data & analysis-ready data sets
• IPD Sharing Time Frame: start date :January 1 2028 end date : December 31 2030
• IPD Sharing Access Criteria: Researchers who confirm that the data will be only used for medical scientific purposes, as per World Medical Association Helsinki Declaration 2024 will be able to submit their coordinates, and the data sets will be shared with them.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No