Gatorade dye could stop fake urine samples in drug tests
NCT ID NCT07356349
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 114 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jan 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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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
Only the study team decides who joins. These are the ways to reach them.
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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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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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