Substance Use Disorder (SUD)Phase 3ATTESTEDNCT07356349
Study to Confirm the AuthenTicity of Point of Care Urine samplEs Using Oral fluoreScein Sodium in adulTs With substancE Use Disorder (ATTESTED)
A Phase 3 study testing Fluorescein in people with Substance Use Disorder (SUD), run by UpTru Inc..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Substance Use Disorder (SUD)
- What is being tested?
- Fluorescein
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 114 participants
- Where
- No sites listed yet
- Study dates
- 15 Jan 2026to 31 Dec 2026
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Conditions
- Substance Use Disorder (SUD)
- Being tested
- Fluorescein, placebo
- Keywords
- randomized controlled trial, substitution heuristic
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluoresceinDrug
Also called Experimental: Fluorescein
Oral ingestion of 100 mg of fluorescein in 250 ml of Gatorade tm
placeboOther
Ingestion of 250 ml of Gatorade tm without fluorescein
| Study group | Role | What they receive |
|---|---|---|
| Fluorescein | Experimental | Ingestion of 100 mg of fluorescein with 250 ml Gatorade tm Receives: Drug: Fluorescein |
| placebo | Placebo comparator | ingestion of 250 ml Gatorade tm without fluorescein Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection
Presence of fluorescence
Measured: 15 minutes post ingestion
Detection
Presence of fluorescence .30,000 using fluorometer
Measured: 15 minutes post ingestion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study start15 Jan 2026 (estimated)
- Primary completion30 Sep 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance Use Disorder (SUD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double blinded randomized controlled trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UpTru Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07356349
- Sponsor's protocol ID
- UPTRu-301
- Acronym
- ATTESTED
- Status last verified
- Jan 2026
- First submitted
- 12 Jan 2026
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: raw data \& analysis-ready data sets