Predicting Oxycodone Dose From Oral Fluid Drug Levels

NCT01928303 | Completed

• 1 other identifier: 1212013319
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain

Keywords

opioids; chronic pain; oxycodone; oxymorphone; patients using opioid pain medication

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 72 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (1)

Weill Cornell Medical College Pain Medicine Center

New York, New York, 10065, United States

Location

Related 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. doi: 10.1016/j.forsciint.2007.03.008. Epub 2007 Apr 16.

  PMID: 17434274 BACKGROUND

• 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.

  PMID: 17988455 BACKGROUND

• 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.

  PMID: 12501910 BACKGROUND

• Crouch D, Day J, Baudys J. Evaluation of aliva/oral fluid as an alternate drug testing specimen. NIJ Report 605-04 (2004).

  BACKGROUND

• 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.

  PMID: 15010104 BACKGROUND

• 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.

  PMID: 11876575 BACKGROUND

• Jickells, S and Negrusz, A (editors). (2008) Clarke's Analytical Forensic Toxicology. London: Pharmaceutical Press

  BACKGROUND

• Lacy, C, Armstrong, L, Golman, M, and Lance, L (editors). (2011) Drug Information Handbook (20th ed). Hudson, OH: Lexicomp

  BACKGROUND

• 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.

  PMID: 10465240 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Once received into the laboratory at AFTS labs, oral fluid, blood and urine specimens will be aliquoted for analysis, and any remaining sample will be transferred to long term storage at -20 - 0°C.

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Attending of Anesthesiology

Study Record Dates

• First Submitted: August 16, 2013
• First Posted: August 23, 2013
• Study Start: March 1, 2013
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: September 15, 2014

Record last verified: 2014-09

Locations

US (1)