Drug Screening System Method Comparison
Part of paid clinical trials in Decatur, Georgia.
- Sponsor
- Intelligent Bio Solutions Inc.
- Study ID
- NCT06618183
- Status
- Recruiting
Conditions
- Reagent Kits, Diagnostic
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 65 Years
- Healthy Volunteers
- Accepted
Interventions
- Fingerprint sweat drug screen — DIAGNOSTIC_TESTQualitative lateral-flow immunoassay analysis of fingerprint sweat specimen
- Fingerprint sweat laboratory analysis — DIAGNOSTIC_TESTLaboratory analysis of fingerprint sweat specimen by liquid chromatography/tandem mass spectrometry
Study Details
Prospective, open-label, single-dose, randomized, multi-site performance evaluation of the accuracy and usability Intelligent Fingerprinting Drug Screening System in the hands of intended users: "operators" and "donors."
Key Dates
- Start date
- Aug 26, 2024
- Status verified
- Sep 2024
- Primary completion
- Nov 30, 2024
- Completion
- Dec 31, 2024
Study Design
- Enrollment
- 135 participants (estimated)
Arms
- Arm: 1Donors randomized into the 0 mg codeine dosage block
- Arm: 2Donors randomized into the 30 mg codeine dosage block
- Arm: 3Donors randomized into the 60 mg codeine dosage block
Primary Outcome Measure
Method Comparison [ Time Frame: 30 minutes to 3 hours ]
Locations (3)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| CenExel iResearch | Decatur | Georgia | 30030 | Kimball Johnson, MD |
| CenExel HRI | Berlin | New Jersey | 08009 | Cassie Blanchard, PhD |
| CenExel HRI | Marlton | New Jersey | 08053 | Elan Cohen, PhD |