Clinical trial NCT01928303: Predicting Oxycodone Dose From Oral Fluid Drug Levels
Official title: Predicting Oxycodone Dose From Oral Fluid Drug Levels For Chronic Pain Management Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Pain
Keywords: opioids
chronic pain
oxycodone
oxymorphone
patients using opioid pain medication
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2013-08-23
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 72
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects will be generally healthy males and females who are undergoing treatment for chronic pain.

Brief 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.

Detailed description: Each potential subject will be requested to verify their willingness to participate in the study by signing and dating an Informed Consent Form and the Health Insurance Portability and Accountability Act (HIPAA) Authorization for use of protected health information in research.

The donor will produce a sample by placing a collection swab under his or her tongue until the indicator window turns blue. To ensure the validity of the sample, the donor may not eat, drink, or consume candy for ten minutes prior to the collection time.

A second oral fluid sample will be obtained for the purpose of determining salivary pH at the time of collection. The donors will expel oral fluid into a small collection cup or spoon, and the collector will determine pH using specialized pH strips.

Urine samples will be collected from donors in approved specimen cups according to protocols indicated by the New York State Department of Health guidelines. Blood samples will be collected by trained and certified medical professionals using appropriate collection tubes.

Participating donors will also be requested to complete a questionnaire regarding information including age, weight, and medication information (including type of medication, dosage, dosing pattern, and time of last dose), and medical history (concerning known health issues).

Eligibility criteria: Inclusion Criteria:

* Adults between 18 and 72 years of age
* Chronic pain patient at Weill Cornell Medical College Pain Medicine Center

Exclusion Criteria:

* taking any medications that can alter the metabolism of oxycodone or oxymorphone in the body
* not a chronic pain patient at Weill Cornell Medical College Pain Medicine Center

Primary outcomes:
measure: original dose of drug consumed (mg) as predicted by the drug concentration in the oral fluid (ng/mL)
timeFrame: subjects will be followed for 6 months after enrollment.
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Medical College Pain Medicine Center
state: New York
Study officials:
References:
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