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Predicting Oxycodone Dose From Oral Fluid Drug Levels (AFTSLabs)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01928303
Recruitment Status : Completed
First Posted : August 23, 2013
Last Update Posted : September 15, 2014
Sponsor:
Information provided by (Responsible Party):
Neel Mehta, Weill Medical College of Cornell University

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.

Condition or disease
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).

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Study Type : Observational
Actual Enrollment : 55 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Predicting Oxycodone Dose From Oral Fluid Drug Levels For Chronic Pain Management Patients
Study Start Date : March 2013
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain
Drug Information available for: Oxycodone

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.



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


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.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 72 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects will be generally healthy males and females who are undergoing treatment for chronic pain.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01928303


Locations
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United States, New York
Weill Cornell Medical College Pain Medicine Center
New York, New York, United States, 10065
Sponsors and Collaborators
Weill Medical College of Cornell University
Publications:
Crouch D, Day J, Baudys J. Evaluation of aliva/oral fluid as an alternate drug testing specimen. NIJ Report 605-04 (2004).
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

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Responsible Party: Neel Mehta, Assistant Attending of Anesthesiology, Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT01928303    
Other Study ID Numbers: 1212013319
First Posted: August 23, 2013    Key Record Dates
Last Update Posted: September 15, 2014
Last Verified: September 2014
Keywords provided by Neel Mehta, Weill Medical College of Cornell University:
opioids
chronic pain
oxycodone
oxymorphone
patients using opioid pain medication
Additional relevant MeSH terms:
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Chronic Pain
Pain
Neurologic Manifestations