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

NCT07356349 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: UPTRu-301
• Study Type: interventional
• Target: 114
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Substance Use Disorder (SUD)

Keywords

randomized controlled trial; substitution heuristic

Outcome Measures

Primary Outcomes (2)

• Detection

  Presence of fluorescence

  15 minutes post ingestion

• Detection

  Presence of fluorescence .30,000 using fluorometer

  15 minutes post ingestion

Study Arms (2)

Fluorescein

EXPERIMENTAL

Ingestion of 100 mg of fluorescein with 250 ml Gatorade tm

Drug: Fluorescein

placebo

PLACEBO COMPARATOR

ingestion of 250 ml Gatorade tm without fluorescein

Other: placebo

Interventions

Fluorescein DRUG

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

Also known as: Experimental: Fluorescein

Fluorescein

placebo OTHER

Ingestion of 250 ml of Gatorade tm without fluorescein

placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• UpTru Inc.: lead

Related Links

• Sponsor's Home Page
• Related Info

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

Fluorescein

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Fluoresceins; Spiro Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Xanthenes; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Polycyclic Compounds

Central Study Contacts

Mark Dubé R President UPTru inc., MD

CONTACT

1 7055222263; mark.dube@upreu.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Double blinded randomized controlled trial

Study Record Dates

• First Submitted: January 12, 2026
• First Posted: January 21, 2026
• Study Start: January 15, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Time Frame: start date :January 1 2028 end date : December 31 2030
• 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.