CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 55 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
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Search/NCT01928303
NCT01928303N/ACompleted

Predicting Oxycodone Dose From Oral Fluid Drug Levels For Chronic Pain Management Patients

Weill Medical College of Cornell University·observational·Posted Aug 23, 2013·Updated Sep 15, 2014

In Brief

An observational study for Chronic Pain. Completed, enrolled 55 participants across 1 site.

Detailed Summary

This study will develop and test an algorithm that will estimate drug dosage from drug levels measured in oral fluid (saliva). Traditionally, urine has been used as the principle medium to monitor drug compliance in patients receiving opioids for chronic pain as well as those being treated for substance abuse. Recently, the use of saliva as an alternative to urine drug testing has been gaining in popularity. Oral fluid has several advantages over urine as a medium for drug screening. In this study, oral fluid, urine and blood specimens will be collected from volunteer patient donors with chronic pain taking opioid medications. Samples from the anonymous donor will be analyzed for opiate class drugs, using New York State Department of Health approved and validated laboratory methods. Analytical results and other information collected will assist in evaluating the use of oral fluid as a specimen to detect opiate drug levels. The measurement of drug concentrations in blood and oral fluid simultaneously will allow for the determination of the amount of oral fluid that will be needed for successful drug testing. It is proposed that by measuring oral fluid drug levels an estimate of the amount of drug taken will be possible.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Pain
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedAug 23, 2013
Enrollment StartMar 1, 2013
Primary CompletionAug 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 12.9 years ago