Predicting Oxycodone Dose From Oral Fluid Drug Levels
Condition: Chronic Pain
MeSH terms: Chronic Pain
Study type: Observational

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).
    

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.
      
Biospecimen description: 
      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.
    
Keywords: opioids; chronic pain; oxycodone; oxymorphone; patients using opioid pain medication