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临床试验/NCT07356349
NCT07356349尚未招募3 期

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

UpTru Inc.0 个研究点目标入组 114 人开始时间: 2026年1月15日最近更新:
干预措施

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
114
主要终点
Detection

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • • 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.

排除标准

  • 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.

研究组 & 干预措施

Fluorescein

Experimental

Ingestion of 100 mg of fluorescein with 250 ml Gatorade tm

干预措施: Fluorescein (Drug)

placebo

Placebo Comparator

ingestion of 250 ml Gatorade tm without fluorescein

干预措施: placebo (Other)

结局指标

主要结局

Detection

时间窗: 15 minutes post ingestion

Presence of fluorescence

次要结局

未报告次要终点

研究者

发起方
UpTru Inc.
申办方类型
Industry
责任方
Sponsor

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