Predicting Oxycodone Dose From Oral Fluid Drug Levels
| Status: | Completed |
|---|---|
| Conditions: | Chronic Pain, Chronic Pain |
| Therapuetic Areas: | Musculoskeletal |
| Healthy: | No |
| Age Range: | 18 - 72 |
| Updated: | 11/8/2014 |
| Start Date: | March 2013 |
| End Date: | January 2016 |
| Contact: | Neel Mehta, MD |
| Email: | nem9015@med.cornell.edu |
| Phone: | 646 962-0474 |
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.
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.
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 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).
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
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