NCT07192887

Brief Summary

To develop and validate a urine drug screen to detect thebaine.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
10mo left

Started May 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress55%
May 2025Mar 2027

Study Start

First participant enrolled

May 7, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 12, 2025

Completed
4 months until next milestone

First Posted

Study publicly available on registry

September 25, 2025

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

September 25, 2025

Status Verified

September 1, 2025

Enrollment Period

1.8 years

First QC Date

June 12, 2025

Last Update Submit

September 17, 2025

Conditions

Urine Specimen Collection

Outcome Measures

Primary Outcomes (1)

  • Validate thebaine urine screen

    Validate a liquid chromatography-tandem mass spectrometry method to detect thebaine in urine

    Enrollment to 48 hours after enrollment

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Flyers will be posted throughout the medical center for recruiting.

You may qualify if:

  • Male or female
  • Ages 18-65
  • Healthy

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

RECRUITING

Study Officials

  • Charlotte Walter, MD

    Children's Hospital Medical Center, Cincinnati

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Charlotte Walter, MD

CONTACT

513-636-4408charlotte.walter@cchmc.org

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 12, 2025

First Posted

September 25, 2025

Study Start

May 7, 2025

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Last Updated

September 25, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)