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_TEST
    Qualitative lateral-flow immunoassay analysis of fingerprint sweat specimen
  • Fingerprint sweat laboratory analysis — DIAGNOSTIC_TEST
    Laboratory 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

First listed
Oct 1, 2024
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: 1
    Donors randomized into the 0 mg codeine dosage block
  • Arm: 2
    Donors randomized into the 30 mg codeine dosage block
  • Arm: 3
    Donors randomized into the 60 mg codeine dosage block

Primary Outcome Measure

Method Comparison [ Time Frame: 30 minutes to 3 hours ]

Locations (3)

FacilityCityStateZIPSite coordinators
CenExel iResearchDecaturGeorgia30030
Candice Hartley, M.Ed., Ed.S.
404-537-1281
Kimball Johnson, MD
CenExel HRIBerlinNew Jersey08009
Danielle Brudon, B.S
856.753.7335
Cassie Blanchard, PhD
CenExel HRIMarltonNew Jersey08053
Lindsay Moellers
856-452-9901
Elan Cohen, PhD

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