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Not yet recruiting NCT07356349

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

Phase III Interventional Substance Use Disorder (SUD)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Fluorescein, placebo.
Who it may be relevant to
Registry conditions: Substance Use Disorder (SUD). Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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

Primary outcome measures

  • Detection [Time frame: 15 minutes post ingestion]
  • Detection [Time frame: 15 minutes post ingestion]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Diagnostic

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07356349 · UPTRu-301

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗