Urine Specimen CollectionNCT07192887
Thebaine Urine Testing
An observational study of Urine Specimen Collection, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial summary
To develop and validate a urine drug screen to detect thebaine. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Urine Specimen Collection
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 7 May 2025to 13 Aug 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Flyers will be posted throughout the medical center for recruiting.
Who may be able to join
- Male or female
- Ages 18-65
- Healthy
Who cannot join
- Allergy to poppy seeds, or any of the related food stuffs used in the study
- Celiac disease or gluten sensitivity
- Ongoing or opioid use in the past 6 months
- History of renal or hepatic disease or dysfunction
- Inability or unwillingness to give repeated urine specimens
- Unwillingness to refrain from eating poppy seed-containing products during the two-day course of the study
Show all 10Show fewer
- Non-English speakers (due to study materials being in English)
- BMI greater than 30
- Antibiotic use in the previous 2 months
- Recent ingestion of poppy seeds from the previous 7 days
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
Official title: Clinical Feasibility of Thebaine Urine Mass Spectrometry Drug Testing
To develop and validate a urine drug screen to detect thebaine.
- Conditions
- Urine Specimen Collection
What is being measured
The primary outcome is the main question the study is designed to answer.
Validate thebaine urine screen
Validate a liquid chromatography-tandem mass spectrometry method to detect thebaine in urine
Measured: Enrollment to 48 hours after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2025
- Study start7 May 2025
- Primary completion13 Aug 2026
- Study completion13 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urine Specimen CollectionStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Charlotte Walter, MD, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07192887
- Sponsor's protocol ID
- 2024-0818
- Status last verified
- Oct 2026
- First submitted
- 12 Jun 2025
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Feasibility of Thebaine Urine Mass Spectrometry Drug Testing
- ClinicalTrials.gov ID
- NCT07192887
- Acronym / sponsor ID
- 2024-0818
- Conditions
- Urine Specimen Collection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Study start
- 7 May 2025 (actual)
- Primary completion
- 13 Aug 2026 (actual)
- Study completion
- 13 Aug 2026 (actual)
- First posted
- 25 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To develop and validate a urine drug screen to detect thebaine.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Flyers will be posted throughout the medical center for recruiting.
Key inclusion criteria (3 listed)
- Male or female
- Ages 18-65
- Healthy
Key exclusion criteria (10 listed)
- Allergy to poppy seeds, or any of the related food stuffs used in the study
- Celiac disease or gluten sensitivity
- Ongoing or opioid use in the past 6 months
- History of renal or hepatic disease or dysfunction
- Inability or unwillingness to give repeated urine specimens
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Validate thebaine urine screen
Time frame: Enrollment to 48 hours after enrollment
Validate a liquid chromatography-tandem mass spectrometry method to detect thebaine in urine
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charlotte Walter, MD principal investigator
Children's Hospital Medical Center, Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urine Specimen Collection, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validate thebaine urine screen (time frame: Enrollment to 48 hours after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.