Predicting Oxycodone Dose From Oral Fluid Drug Levels (AFTSLabs)

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

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 Overview

• Status: Completed
• Conditions: Chronic Pain

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).

• Study Type: Observational
• Enrollment (Actual): 55

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • Weill Cornell Medical College Pain Medicine Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 72 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects will be generally healthy males and females who are undergoing treatment for chronic pain.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Chronic Pain Patients taking opioid medications; Oral fluid, blood and urine samples will be obtained from chronic pain patients who are taking pain medications from the opioid class of drugs.
Negative controls; At least 10% of the total subject population. Chronic pain patients who are not taking pain medication from the opioid class of drugs.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
original dose of drug consumed (mg) as predicted by the drug concentration in the oral fluid (ng/mL)	The primary goal of the study is to develop and test an algorithm that will estimate drug dosage from measured oral fluid drug levels.	subjects will be followed for 6 months after enrollment.

Collaborators and Investigators

• Sponsor: Weill Medical College of Cornell University

Publications and helpful links

General Publications

• Bush DM. The U.S. Mandatory Guidelines for Federal Workplace Drug Testing Programs: current status and future considerations. Forensic Sci Int. 2008 Jan 30;174(2-3):111-9. doi: 10.1016/j.forsciint.2007.03.008. Epub 2007 Apr 16.
• Cone EJ, Clarke J, Tsanaclis L. Prevalence and disposition of drugs of abuse and opioid treatment drugs in oral fluid. J Anal Toxicol. 2007 Oct;31(8):424-33. doi: 10.1093/jat/31.8.424. Erratum In: J Anal Toxicol. 2008 Mar;32(2):199-200.
• Cone EJ, Presley L, Lehrer M, Seiter W, Smith M, Kardos KW, Fritch D, Salamone S, Niedbala RS. Oral fluid testing for drugs of abuse: positive prevalence rates by Intercept immunoassay screening and GC-MS-MS confirmation and suggested cutoff concentrations. J Anal Toxicol. 2002 Nov-Dec;26(8):541-6. doi: 10.1093/jat/26.8.541.
• Crouch D, Day J, Baudys J. Evaluation of aliva/oral fluid as an alternate drug testing specimen. NIJ Report 605-04 (2004).
• Heit HA, Gourlay DL. Urine drug testing in pain medicine. J Pain Symptom Manage. 2004 Mar;27(3):260-7. doi: 10.1016/j.jpainsymman.2003.07.008.
• Hemeryck A, Belpaire FM. Selective serotonin reuptake inhibitors and cytochrome P-450 mediated drug-drug interactions: an update. Curr Drug Metab. 2002 Feb;3(1):13-37. doi: 10.2174/1389200023338017.
• Jickells, S and Negrusz, A (editors). (2008) Clarke's Analytical Forensic Toxicology. London: Pharmaceutical Press
• Lacy, C, Armstrong, L, Golman, M, and Lance, L (editors). (2011) Drug Information Handbook (20th ed). Hudson, OH: Lexicomp
• Speckl IM, Hallbach J, Guder WG, Meyer LV, Zilker T. Opiate detection in saliva and urine--a prospective comparison by gas chromatography-mass spectrometry. J Toxicol Clin Toxicol. 1999;37(4):441-5. doi: 10.1081/clt-100102434.

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (ACTUAL): August 1, 2014
• Study Completion (ACTUAL): August 1, 2014

Study Registration Dates

• First Submitted: August 16, 2013
• First Submitted That Met QC Criteria: August 19, 2013
• First Posted (ESTIMATE): August 23, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): September 15, 2014
• Last Update Submitted That Met QC Criteria: September 12, 2014
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Keywords: chronic pain; opioids; oxycodone; oxymorphone; patients using opioid pain medication
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: 1212013319