Predicting Oxycodone Dose From Oral Fluid Drug Levels

Chronic Pain Clinical Trial

— AFTSLabs  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01928303
• Other study ID #: 1212013319
• Status: Completed
• Phase: N/A
• First received: August 16, 2013
• Last updated: September 12, 2014
• Start date: March 2013
• Est. completion date: August 2014

Study information

• Verified date: September 2014
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 72 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Pain

Locations

Country	Name	City	State
United States	Weill Cornell Medical College Pain Medicine Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

References & Publications (9)

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. Epub 2007 Apr 16. — View Citation

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. Erratum in: J Anal Toxicol. 2008 Mar;32(2):199-200. — View Citation

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No