Cutoff Assessment for Codeine in Fingerprint Sweat Relative to Oral Fluid, Following Controlled, Oral Administration of Codeine Phosphate Tablets to 40 Healthy Adults

This is a prospective, observational, open-label, single-site, in-clinic study with two 20-subject cohorts. Each subject receives two (2) doses of 60mg codeine phosphate in tablet form, the second dose four (4) hours after the first.

The primary objective of this study is to compare data from a fingerprint sweat opiate fluorescence immunoassay screening method to oral fluid opiate screening in subjects dosed with codeine phosphate. Fluorescence measurement data from the fingerprint sweat screening method will be analyzed post hoc to select the fingerprint sweat codeine cutoff best aligned with the oral fluid cutoff.

The secondary objective is to compare LC-MS/MS data from fingerprint sweat specimens and oral fluid in order to select the fingerprint sweat codeine cutoff best aligned with codeine in oral fluid.