Urine test to detect thebaine
Clinical Feasibility of Thebaine Urine Mass Spectrometry Drug Testing
This study will test a urine screening method to detect thebaine in healthy adults aged 18 to 65.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Children's Hospital Medical Center, Cincinnati Academic / other |
| Locations | 1 site (Cincinnati, Ohio) |
| Trial ID | NCT07192887 on ClinicalTrials.gov |
What this trial studies
Researchers will develop and validate a urine drug screen designed to detect thebaine, an opiate alkaloid. The observational study enrolls healthy adults who will provide repeated urine specimens while following dietary restrictions to avoid poppy-seed contamination. People with recent opioid use, renal or hepatic disease, certain medication exposures, or recent antibiotic use are excluded to reduce confounding. Laboratory analysis will use targeted analytical chemistry methods to determine detection limits, timing of positivity, and test specificity.
Who should consider this trial
Good fit: Ideal candidates are healthy English-speaking adults 18–65 with BMI ≤30 who can provide repeated urine samples and agree to avoid poppy-seed products, recent antibiotics, and opioid use.
Not a fit: Patients with renal or liver disease, recent opioid use or recent poppy-seed ingestion, non-English speakers, or those unable to provide repeated urine specimens are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, clinicians and laboratories could more accurately identify thebaine exposure and reduce misinterpretation of urine drug results.
How similar studies have performed: Related studies using mass spectrometry and targeted assays have detected opiate alkaloids in urine, but formal validation specifically for thebaine is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male or female * Ages 18-65 * Healthy Exclusion Criteria: * 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 * 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
Where this trial is running
Cincinnati, Ohio
- Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Charlotte Walter, MD — Children's Hospital Medical Center, Cincinnati
- Study coordinator: Charlotte Walter, MD
- Email: charlotte.walter@cchmc.org
- Phone: 513-636-4408
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.