Method Comparison of Intelligent Fingerprinting Drug Screening System
Start Date
6/2/2026
Completion Date
8/31/2026
Summary
Prospective, multi-site, open-label, single- or double-dose, randomized, multi-site performance evaluation of accuracy of the Intelligent Fingerprinting Drug Screening System in the hands of intended users: "operators" and "donors."
Detailed Description
This will be a study under non-fasting conditions. The total number of healthy adult "operator" subjects (male and non-pregnant females) required for enrollment in this study protocol is nine (9). The total number of healthy adult "donor" subjects (male and non-pregnant females) required for enrollment in this study protocol is 135. These subjects will be distributed across three sites with the recruiting goal of three (3) operators and 45 subjects per site. Subjects will be recruited to participate as either "operator" or "donor." The total duration of the study, from check-in through the end of the study will be approximately three (3) days for "operators" with no overnight confinement, and one to eight hours for "donors" at two of the sites. At the third site, 31 "donors" will be dosed twice and will remain at the clinic overnight so that biological sampling can occur 24 hours after the first codeine dose. Because the "operators" are required to be at the clinic for three days, they may be recruited separately and compensated at a different rate than the "donors." "Operators" may be employed by the clinic. "Donors" at sites 1 and 2 will be block randomized to one of two cohorts: no codeine dose or 60 mg codeine dose. The goal is to complete the study with approximately 69% of subjects in the 60 mg cohort. "Donors" at site 3 will be randomized into one of two cohorts: no codeine dose or two 60 mg doses. The cohort receiving two 60 mg codeine doses will be confined at the clinic overnight to enable additional biological sampling events.
Eligibility Criteria
Age Range: 18 years to 65 years
Interventions
Diagnostic Test
Conditions
Locations
CenExel Clinical Research
Marlton, New Jersey 08053
United States