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Gatorade dye could stop fake urine samples in drug tests

NCT ID NCT07356349

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests if adding a safe dye to a drink can prove that urine samples are real and not tampered with. About 114 adults with substance use disorder will drink Gatorade with or without the dye, then provide a urine sample 15 minutes later. Researchers will check for the dye in the urine using a special device. The goal is to make drug testing more reliable.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 114 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jan 2026

An estimate. Start dates often move.

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

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  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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